[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diffuse-large-b-cell-lymphoma-dlbcl\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diffuse-large-b-cell-lymphoma-dlbcl":63},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,66,0,25,[9,48,79,110,142,165,194,215,251,279,301,328,366,391,419,445,465,490,525,554,588,612,635,661,681],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100523149","phase-3-a-study-to-compare-how-well-odronextamab-combined-with-chemotherapy-works-and-how-safe-it-is-against-rituximab-combined-with-chemotherapy-in-adult-patients-with-previously-untreated-diffuse-large-b-cell-lymphoma-100523149",false,"NCT06091865","A Study to Compare How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Against Rituximab Combined With Chemotherapy, in Adult Patients With Previously Untreated Diffuse Large B-cell Lymphoma","A Phase 3, Open Label, Randomized Study Comparing the Efficacy and Safety of Odronextamab (REGN1979), an Anti-CD20 × Anti-CD3 Bispecific Antibody, in Combination With CHOP (ODRO-CHOP) Versus Rituximab in Combination With CHOP (R-CHOP) in Previously Untreated Participants With Diffuse Large B-cell Lymphoma (DLBCL) (OLYMPIA-3)","OLYMPIA-3","Key Inclusion Criteria:\n\n1. Previously untreated participants for lymphoma with documented Cluster of Differentiation 20+ (CD20+) DLBCL, as described in the protocol OR relapsed or refractory DLBCL, for whom next available standard of care therapy is not available or deemed ineligible according to the investigator (Part 1A only)\n2. Measurable disease with at least one nodal lesion or at least one extranodal lesion, as described in the protocol\n3. Eastern Cooperative Oncology Group (ECOG) performance status ≤2\n4. Life expectancy ≥ 12 months\n5. International Prognostic Index (IPI) of 3 to 5 (part 1 only) and ≥2 (part 2) for untreated DLBCL only\n6. Adequate hematologic and organ function, as defined in the protocol.\n\nKey Exclusion Criteria:\n\n1. Primary Central Nervous System (CNS) lymphoma or known involvement by non-primary CNS NHL and history or current relevant CNS pathology\n2. Another active malignancy, significant active disease or medical condition, as described in the protocol\n3. Peripheral neuropathy Grade ≥3\n4. Treatment with any systemic anti-lymphoma therapy, except for participants with Relapsed\u002FRefractory (R\u002FR) DLBCL and participants with DLBCL transformed from an indolent lymphoma after treatment with systemic anti-lymphoma therapy.\n5. Any other therapy or investigational treatment within 28 days or 5 half-lives of the drug, whichever is shorter, prior to the start of study treatment\n6. Recent major surgery, prior organ transplantation, or standard radiotherapy, as described in the protocol\n7. Allergy\u002Fhypersensitivity to study drugs, as described in the protocol\n8. Infections such as any active infection (bacterial, viral, fungal, mycobacterial, parasitic or other), active Coronavirus Disease (COVID-19) infection, uncontrolled infection with Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV), Cytomegalovirus (CMV) infection, as described in the protocol.\n\nNote: Other protocol-defined Inclusion\u002F Exclusion criteria apply","ALL","18 Years",{"count":21,"type":22},904,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","This study is researching an experimental drug called odronextamab, referred to as study drug, when used in combination with chemotherapy. The study is focused on patients with Diffuse Large B-cell Lymphoma (DLBCL) that have not been treated before (called \"previously untreated\"). Patients with DLBCL that have come back after treatment (called \"relapsed\"), or have not responded to treatment (called \"refractory\"), can also participate in this study.\n\nThis study will be made up of Part 1A, Part 1B, and Part 2.The aim of Part 1A and Part 1B of the study is to see how safe and tolerable the study drug in combination with chemotherapy is and to determine the dose and schedule of the study drug to be combined with chemotherapy in Part 2 of the study.\n\nThe aim of Part 2 of the study is to see how effective the combination of the study drug with chemotherapy is in comparison with the combination of rituximab (the comparator drug), and chemotherapy, the current standard of care treatment approved for DLBCL. Standard of care means the usual medication expected and used when receiving treatment for a condition.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drug when combined with chemotherapy\n* How much study drug is in the blood at different times\n* Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)\n* The impact from the study drug on quality of life and ability to complete routine daily activities",[28],"Diffuse Large B-cell Lymphoma (DLBCL)",[30,31,32,33,34],"Non-Hodgkin Lymphomas (NHL)","B-cell Non-Hodgkin Lymphomas (B-NHL)","Diffuse Large B-cell Lymphoma","Odronextamab","Anti-CD20 × anti-CD3 bispecific antibody","RECRUITING","2026-08-19",{"date":38,"type":39},"2026-08-20","ACTUAL",{"date":41,"type":39},"2023-12-13",{"date":43,"type":22},"2029-09-12",{"name":45,"class":46},"Regeneron Pharmaceuticals","INDUSTRY",178,{"id":49,"slug":50,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":59,"conditions":60,"keywords":64,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":78},"100641004","phase-2-epcoritamab-in-combination-with-r-chop-for-patients-with-aggressive-non-hodgkin-lymphoma-100641004","NCT07588698","Epcoritamab in Combination With R-CHOP for Patients With Aggressive Non-Hodgkin Lymphoma","Epcoritamab in Combination With R-CHOP Debulking in Newly Diagnosed Patients With Aggressive Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n1. Participants must have confirmed CD20-positive aggressive B-cell lymphoma, including de novo or transformed diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS); high-grade B-cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangement; primary mediastinal large B-cell lymphoma (PMBCL); T-cell\u002Fhistiocyte-rich large B-cell lymphoma (THRLBCL); Epstein-Barr virus-positive DLBCL, NOS; or follicular lymphoma grade 3b.\n2. Measurable disease per Lugano 2014 criteria.\n3. No prior therapy for DLBCL or FL G3B other than corticosteroids or palliative radiotherapy. Of note, a cycle of anthracycline-containing regimen (given as standard of care prior to study enrollment) is allowed, provided that patients will receive a total of six cycles of chemotherapy as part of their treatment plan. Patients who received one cycle of an anthracycline-containing regimen prior to enrollment will proceed directly to Cycle 2 on study.\n4. Age ≥18 years\n5. Participants must have an International Prognostic Index (IPI) score of 2-5.\n6. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)\n7. Demonstrates adequate organ function as defined below:\n\n   Adequate bone marrow function:\n\n   absolute neutrophil count platelets\n   * 1.0 × 10⁹\u002FLitre (L) (with growth factor use allowed)\n   * 75 × 10⁹\u002FL\n\n   Exceptions:\n\n   Patients may be enrolled despite not meeting the thresholds above if either of the following applies, provided the Absolute Neutrophil Count (ANC) is ≥0.75 × 10⁹\u002FL:\n   1. The patient has received one prior cycle of chemotherapy off study, and cytopenias at Cycle 2, Day 1 of protocol therapy are believed to be due to recent chemotherapy, provided there is evidence of marrow recovery and no other contraindications.\n   2. The patient has documented bone marrow involvement by lymphoma, and cytopenias are believed to be disease-related rather than indicative of poor marrow reserve or unrelated pathology. In such cases, enrollment is permitted at the discretion of the investigator if the patient is otherwise eligible and deemed safe to proceed.\n\n   Adequate hepatic function:\n\n   Total bilirubin\n\n   ≤2 × upper limit of normal (ULN) (unless due to Gilbert's)\n\n   Aspartate aminotransferase (AST) Serum glutamic-oxaloacetic transaminase (SGOT)\n\n   ≤3 × institutional upper limit of normal\n\n   Alanine aminotransferase (ALT) Serum glutamic-pyruvic transaminase (SGPT)\n\n   ≤3 × institutional upper limit of normal\n\n   Adequate renal function:\n\n   As assessed by estimated glomerular filtration rate (eGFR)\n\n   Coagulation:\n\n   Prothrombin time (PT) International Normalized Ratio (INR) and Activated partial thromboplastin time aPTT\n\n   ≤1.5 × ULN, unless receiving anticoagulation therapy\n8. Left ventricular ejection fraction (LVEF) ≥50% by multigated acquisition (MUGA) or echocardiography at screening.\n9. Ability to understand and the willingness to sign a written informed consent document.\n10. .Human immunodeficiency virus (HIV)-infected individuals are eligible if the following criteria are met:\n\n    1. Serum HIV viral load is \\\u003C lower limit of detection (LLD) and controlled with antiretroviral therapy for at least 1 year prior to enrollment, with confirmatory testing at screening;\n    2. CD4 count ≥ 200 cells\u002Fmicroliter (μL) at screening;\n    3. Subject is receiving antiretroviral regimens in accordance with current International Acquired Immunodeficiency Syndrome (AIDS) Society guidelines;\n    4. No evidence of AIDS-defining illnesses (other than lymphoma diagnosis) or active opportunistic infections;\n    5. Antiretroviral therapy does not interfere with study medications.\n11. For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.\n12. Individuals with a history of hepatitis C virus (HCV) infection must have been treated and cured. For individuals with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.\n13. Individuals with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n14. The effects of epcoritamab on the developing human fetus are unknown. For this reason, and because bispecific antibodies may be teratogenic, women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, or abstinence). Woman with reproductive potential must agree to use adequate contraception during the trial, and for 12 months after the last administration of epcoritamab or according to the local prescribing information of the standard of care (SOC) regimens, whichever is the longest. Adequate contraception is defined as highly effective methods of contraception. Also refer to the local prescribing information for information regarding contraceptive requirements for the SOC regimens.\n15. A woman of childbearing potential must have a negative serum (beta-hCG) pregnancy test at screening and a negative urine pregnancy test before treatment administration on Day 1 of every cycle.\n16. A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the trial and for 12 months after receiving the last dose of epcoritamab or according to the local prescribing information of the SOC regimens, whichever is the longest.\n17. A man who is sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a barrier method of birth control, eg, either condom with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository or partner with occlusive cap (diaphragm or cervical\u002Fvault caps) with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository, and all men must also not donate sperm during the trial and for 12 months after receiving the last dose of epcoritamab or according to the local prescribing information of the SoC regimens, whichever is the longest.\n18. Participants must agree not to donate blood for 60 days after receiving the last dose of trial treatment.\n19. Participants must have a treating physician at University of California, San Francisco (UCSF) or Zuckerberg San Francisco General Hospital (ZSFGH), receive study treatment under the supervision of the study Principal Investigator or qualified study sub-investigators at the enrolling site, and be willing to comply with study procedures.\n\nExclusion Criteria:\n\n1. History of severe allergic or anaphylactic reactions to anti-CD20 mAb therapy or known allergy or intolerance to any component or excipient of epcoritamab.\n2. Any prior treatment with a bispecific antibody targeting CD3 and CD20.\n3. Treatment with an investigational drug within 4 weeks or 5 half-lives, whichever is longer, prior to the first dose of epcoritamab.\n4. Requiring immunosuppressive therapy for an ongoing baseline medical condition. For corticosteroids, prednisolone \\>10 mg daily (or equivalent) qualifies as immunosuppressive and thus be excluded for this use. Note: corticosteroids at any dose are permitted for control of lymphoma related symptoms, including during screening, and for any adverse events (AE) management during study.\n5. Vaccination with live vaccines within 28 days prior to the first dose of epcoritamab.\n6. Clinically significant cardiovascular disease, including:\n\n   1. Myocardial infarction within 6 months prior to the first dose of epcoritamab, or unstable or uncontrolled disease\u002Fcondition related to or affecting cardiac function (eg, unstable angina, congestive heart failure New York Heart Association Class III-IV), cardiac arrhythmia (NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5 Grade 3 or higher), or clinically significant electrocardiogram (ECG) abnormalities\n   2. Screening 12-lead ECG showing a baseline QT Corrected for Heart Rate using Fridericia's Formula (QTcF) \\>470 msec\n   3. Stroke within 6 months prior to first epcoritamab dose\n7. Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at trial enrolment or significant infections within 2 weeks prior to the first dose of epcoritamab.\n8. Active hepatitis B Virus (HBV) (Deoxyribonucleic Acid Polymerase Chain Reaction (DNA PCR) -positive) or hepatitis C (Ribonucleic Acid Polymerase Chain Reaction (RNA PCR) -positive infection). Subjects with evidence of prior HBV but who are PCR-negative are permitted in the trial but should receive prophylactic antiviral therapy. Subjects who received treatment for Hepatitis C Virus (HCV) that was intended to eradicate the virus may participate if hepatitis C Ribonucleic acid (RNA) levels are undetectable.\n9. Known past or current malignancy other than inclusion diagnosis, except for:\n\n   1. Cervical carcinoma of Stage 1B or less\n   2. Non-invasive basal cell or squamous cell skin carcinoma\n   3. Non-invasive, superficial bladder cancer\n   4. Prostate cancer with a current Prostate-Specific Antigen (PSA) level \\\u003C 0.1 ng\u002Fmilliliter (mL)\n   5. Any curable cancer with a complete response (CR) of \\> 2 years duration.\n10. Neuropathy \\> grade 1 with the exception of neuropathy directly related to lymphoma (e.g., direct nerve compression from tumor).\n11. . Female who is pregnant, breast-feeding, or planning to become pregnant while enrolled in this trial or within 12 months after the last dose of epcoritamab; female subjects must also agree not to breastfeed during the entire trial and until 12 months after the last administration of study drug.\n12. Male who plans to father a child while enrolled in this trial or within 12 months after the last dose of epcoritamab.\n13. Contraindication to any of the individual drugs of the R-CHOP regimen.",{"count":56,"type":22},20,[58],"PHASE2","A Phase II, open-label, two-arm, multicenter study evaluating the combination of epcoritamab with R-CHOP chemotherapy in patients with newly diagnosed, aggressive B-cell non-Hodgkin lymphoma.",[61,62,63],"Non-Hodgkin's B-cell Lymphoma","Lymphoma Non-Hodgkin","Diffuse Large B-Cell Lymphoma (DLBCL)",[65,66,67],"Newly diagnosed B-cell lymphoma patients","Combination immunotherapy chemotherapy","epcoritamab R-CHOP lymphoma trial","NOT_YET_RECRUITING","2026-08-17",{"date":36,"type":39},{"date":72,"type":22},"2026-09-15",{"date":74,"type":22},"2029-08-31",{"name":76,"class":77},"Carrie Ho, MD","OTHER",2,{"id":80,"slug":81,"hasResults":12,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":23,"phases":88,"briefSummary":90,"conditions":91,"keywords":98,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":4},"100649540","phase-1-a-phase-12-study-of-ub-vv400-with-rapamycin-in-relapsedrefractory-b-cell-malignancies-100649540","NCT07735533","A Phase 1\u002F2 Study of UB-VV400 With Rapamycin in Relapsed\u002FRefractory B-cell Malignancies","A Phase 1\u002F2, Open-label, Multicenter Study of UB-VV400 With Rapamycin in Relapsed or Refractory B-cell Malignancies","Inclusion Criteria:\n\n1. 18 years or older\n2. Provides voluntary written informed consent\n3. Relapsed or refractory large B-cell lymphoma (LBCL)\n4. Measurable disease according to Lugano 2014 criteria\n5. Confirmed CD22 expression\n6. No serious concomitant diseases or active\u002Funcontrolled infections\n7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n8. Adequate organ function\n\nExclusion Criteria:\n\n1. Women who are pregnant or breastfeeding\n2. Current isolated central nervous system (CNS) involvement\n3. Prior allogeneic bone marrow transplant, gene therapy, or adoptive cell transfer (except tumor-infiltrating lymphocytes, CAR-NK cells, T-cell receptor \\[TCR\\] fusion constructs, TCR T cells, and CAR T cells)\n4. History of or active human immunodeficiency virus (HIV)\n5. Active or chronic hepatitis B, or active hepatitis C\n6. Systemic immunodeficiency diseases, except for well-controlled Type I diabetes or thyroid disease\n7. Ongoing CNS disease that would preclude neurologic assessment\n8. Uncontrolled angina or other acute heart disease\n9. Currently receiving treatment in another interventional clinical trial.",{"count":87,"type":22},274,[89,58],"PHASE1","This study is a Phase 1\u002F2 dose-finding and dose-confirmation study to evaluate the safety and antitumor activity of UB-VV400. The study will enroll patients with relapsed\u002Frefractory B-cell malignancies, including large B-cell lymphoma (LBCL).",[92,62,93,94,95,96,97],"Lymphoma, B Cell","High Grade B Cell Lymphoma","Richter Transformation Lymphoma","Grade 3b Follicular Lymphoma","Primary Mediastinal B Cell Lymphoma","Diffuse Large B Cell Lymphoma (DLBCL)",[99,100,101],"CAR T","chimeric antigen receptor","CD22","2026-08-13",{"date":69,"type":39},{"date":105,"type":22},"2026-08",{"date":107,"type":22},"2031-08",{"name":109,"class":46},"Umoja Biopharma",{"id":111,"slug":112,"hasResults":12,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":23,"phases":119,"briefSummary":120,"conditions":121,"keywords":129,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":133,"lastUpdatePostDateStruct":134,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":141},"100591414","phase-1-dose-determining-study-of-exs73565-in-participants-with-relapsed-or-refractory-b-cell-malignancies-100591414","NCT06980116","Dose Determining Study of EXS73565 in Participants With Relapsed or Refractory B-Cell Malignancies","A Phase 1 Open-label, Multicenter, Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of EXS73565 in Participants With Relapsed or Refractory B-cell Malignancies","Key Inclusion Criteria:\n\n* Age ≥18 years at the time of signing the informed consent.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n* Histologically confirmed diagnosis of one of the following B-cell malignancies: chronic lymphocytic leukemia (CLL), including Richter's transformation from CLL, mantle-cell lymphoma, diffuse large B-cell lymphoma, follicular lymphoma, marginal zone lymphoma, or waldenström macroglobulinaemia.\n* Participants that have relapsed after standard of care or have progressed during standard of care or are not suitable for standard of care therapy\n\nKey Exclusion Criteria:\n\n* Any medical or psychiatric condition that, in the view of the Principal Investigator, could jeopardize or would compromise the participant's safety or ability to participate in the study.\n* Known central nervous system (CNS) malignancy or primary CNS lymphoma.\n* Concurrent active or previous malignancy (other than the primary lymphoma\u002FCLL for which the participant will be treated on this protocol within 5 years prior to randomization; participants with prior cancers may be enrolled with documented Sponsor approval.\n* Received anticancer therapy, including chemotherapy, immunotherapy, radiation therapy (with the exception of palliative radiotherapy), biologic therapy, cancer-related hormonal therapy, or any investigational therapy within 14 days or 5 half-lives (whichever is shorter) before the first dose of the study treatment.",{"count":118,"type":22},85,[89],"The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of EXS73565 administered orally as a single agent in participants with relapsed\u002Frefractory B-cell malignancies.",[122,123,124,125,126,127,128],"Relapsed or Refractory B-cell Malignancies","Chronic Lymphocytic Leukemia\u002FSmall Lymphocytic Lymphoma (CLL\u002FSLL)","Follicular Lymphoma (FL)","Marginal Zone Lymphoma (MZL)","Mantle Cell Lymphoma (MCL)","Diffuse-large B-cell Lymphoma (DLBCL)","Waldenstrom's Macroglobulinemia (WM)",[130,131,124,125,126,127,128,132],"B-cell Malignancies","Chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma (CLL\u002FSLL)","MALT1","2026-08-11",{"date":102,"type":39},{"date":136,"type":39},"2025-03-31",{"date":138,"type":22},"2028-12",{"name":140,"class":46},"Exscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.",17,{"id":143,"slug":144,"hasResults":12,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":149,"enrollmentInfo":150,"targetDuration":4,"studyType":23,"phases":152,"briefSummary":154,"conditions":155,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":4},"100651419","phase-4-pomalidomide-plus-rituximab-maintenance-in-young-high-risk-newly-diagnosed-dlbcl-after-first-line-response-100651419","NCT07760610","Pomalidomide Plus Rituximab Maintenance in Young High-Risk Newly Diagnosed DLBCL After First-Line Response","A Prospective, Single-Arm, Single-Center Clinical Study on the Maintenance Treatment of Young High-Risk Newly Diagnosed Diffuse Large B-Cell Lymphoma (DLBCL) Patients With Pomalidomide Combined With Rituximab.","Inclusion Criteria:\n\n1. Age ≥18 years and \\\u003C60 years, male or female.\n2. Histologically confirmed newly diagnosed diffuse large B-cell lymphoma (DLBCL), with at least a partial response (PR) after first-line therapy.\n3. Age-adjusted International Prognostic Index (aaIPI) \\>1 at initial diagnosis.\n4. Ann Arbor stage II-IV disease at initial diagnosis.\n5. Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-2.\n6. Adequate bone marrow hematopoietic function, defined as absolute neutrophil count ≥1.5 × 10\\^9\u002FL, with granulocyte colony-stimulating factor support allowed; platelet count ≥75 × 10\\^9\u002FL, with platelet transfusion allowed to reach this minimum platelet count; and hemoglobin ≥8.0 g\u002FdL, with prior red blood cell transfusion or recombinant human erythropoietin allowed. If abnormal peripheral blood counts are caused by lymphoma involvement of the bone marrow or spleen, eligibility may be determined at the investigator's discretion.\n7. Adequate major organ function, defined as total serum bilirubin ≤2.0 × upper limit of normal (ULN), serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN, and creatinine clearance \\>30 mL\u002Fmin. For participants with hepatic involvement by lymphoma, eligibility may be determined at the investigator's discretion.\n8. Expected survival of ≥3 months as judged by the investigator.\n9. Ability to understand the study and willingness to provide written informed consent.\n10. Female participants must use effective contraception, must not be pregnant, and must agree n\n\nExclusion Criteria:\n\n1. Presence of another active malignancy that is untreated or currently being treated.\n2. History of severe venous thromboembolism (VTE) or cerebral infarction before treatment.\n3. Active hepatitis B or hepatitis C infection, or human immunodeficiency virus (HIV) seropositivity.\n4. Uncontrolled or severe cardiovascular disease, including myocardial infarction within 3 months before enrollment, unstable coronary artery disease, uncontrolled chronic congestive heart failure, New York Heart Association (NYHA) class III-IV heart failure, or clinically significant pericardial disease.\n5. Uncontrolled hypertension or diabetes mellitus.\n6. Uncontrolled active infection or acute active infection.\n7. Contraindication or allergy to any study drug.\n8. Pregnant or breastfeeding women.\n9. Any severe physical or psychiatric illness that, in the opinion of the protocol or the investigator, may interfere with participation in this clinical study; or any substance abuse, medical, psychological, or social condition that may interfere with study participation or assessment of study results.\n10. Current treatment with other investigational drugs.\n11. Participation in another clinical trial within 1 month before enrollment.\n12. Any other condition that, in the opinion of the investigator, makes the participant unsuitable for enrollment.","60 Years",{"count":151,"type":22},27,[153],"PHASE4","This is a prospective, single-arm, single-center clinical study evaluating pomalidomide combined with rituximab as maintenance treatment in young high-risk patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL) who have achieved at least a partial response after first-line therapy.\n\nEligible participants will receive rituximab 375 mg\u002Fm² by intravenous infusion on Day 1 every 8 weeks and pomalidomide 4 mg orally once daily on Days 1 to 21 of each 28-day cycle. Maintenance treatment is planned for 24 months unless disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-defined discontinuation criteria occur.\n\nThe main purpose of this study is to evaluate the efficacy and safety of this maintenance treatment approach. The primary outcome measure is the 1-year progression-free survival rate. Secondary outcome measures include conversion from partial response to complete response, duration of response, progression-free survival, overall survival, 1-year and 2-year overall survival rates, 2-year progression-free survival rate, minimal residual disease, complete molecular response, immune cell subsets, immune function markers, and adverse events.",[63],"2026-08-10",{"date":158,"type":39},"2026-08-12",{"date":160,"type":22},"2026-09",{"date":162,"type":22},"2029-07",{"name":164,"class":77},"The First Hospital of Jilin University",{"id":166,"slug":167,"hasResults":12,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":4,"eligibilityCriteria":171,"healthyVolunteers":12,"sex":18,"minAge":172,"maxAge":4,"enrollmentInfo":173,"targetDuration":4,"studyType":23,"phases":175,"briefSummary":176,"conditions":177,"keywords":182,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":188,"completionDateStruct":190,"leadSponsor":192,"locationsCount":4},"100650619","phase-1-grace-a-phase-12a-study-of-vtru200-in-relapsedrefractory-aml-high-risk-mds-dlbcl-post-cart-failure-and-advanced-solid-tumors-100650619","NCT07749976","GRACE: A Phase 1\u002F2a Study of VTRU200 in Relapsed\u002FRefractory AML, High-risk MDS, DLBCL Post CART Failure and Advanced Solid Tumors","A Phase I\u002FIIa Dose Escalation and Expansion Study of VTRU200 in Adult and Pediatric Participants With Relapsed\u002FRefractory AML, HR-MDS, DLBCL Post-CART Failure and Advanced Solid Tumors","Inclusion Criteria:\n\n* 1\\. Adults (≥18 years) with\n\nI. Pathologically confirmed acute myeloid leukemia (AML) according to WHO 2022 criteria. Relapsed or refractory AML, defined as either:\n\n1. Refractory AML: Failure to achieve CR, CRh, or CRi after at least 2 courses of intensive induction therapy.\n2. Relapsed AML: Recurrence after prior CR, CRh, or CRi, documented by one or more of the following: Bone marrow blasts \\>5% by morphologic assessment; persistent reappearance of blasts in peripheral blood by morphologic assessment II. HR-MDS: Pathologically confirmed myelodysplastic syndrome (MDS) according to WHO 2022 criteria, with high-risk disease defined as IPSS-R high-risk or very high-risk (score \\>4.5). Ineligible for allogeneic hematopoietic stem cell transplantation.\n\nIII. DLBCL post-CAR T: histologically confirmed DLBCL per WHO 2022 criteria and relapsed or refractory disease after prior CART therapy. Qualifying post-CAR T treatment failure must be documented at least 1 month after CAR T infusion and include no metabolic response, first metabolic progressive disease, or first relapse after prior response. Prior CART infusion must have occurred at least 1 month before screening. Participants must not be in partial metabolic response or complete metabolic response at screening and must have measurable disease on PET\u002FCT (preferred) or CT\u002FMRI, defined as at least 1 nodal lesion \\>1.5 cm or at least 1 extranodal lesion \\>1.0 cm; if PET is used, lesions must be FDG-avid and consistent with active lymphoma IV. Advanced solid tumors 2. Children (6 months-11 years) and adolescents (12-17 years) with R\u002FR-AML.\n\n1. Children and adolescent refractory AML: Bone marrow contains 1% blasts by multiparametic flow cytometry (MFC) at the end of 2 cycles of induction therapy\n2. Children and adolescent relapsed AML: A single bone marrow sample showing 5% leukemic blasts by MFC, fluorescence in situ hybridization (FISH) testing or other molecular method, or a single bone marrow sample with at least two tests showing 1% blasts such as by MFC, karyotypic abnormality with at least one metaphase similar or identical to diagnosis, FISH abnormality identical to one present at diagnosis (above level of sensitivity of specific FISH probe) or polymerase chain reaction (PCR) or next generation sequencing (NGS)-based demonstration of leukemogenic lesion (e.g., fusion, mutation) identical to diagnosis and is quantifiably 1% 3. Eastern Cooperative Oncology Group (ECOG) performance status 0-2 or Karnofsky Performance Score (KPS) ≥50% 4. Adequate organ function: I. Hepatic: Serum AST\u002FALT ≤2.5×ULN and total bilirubin ≤1.5×ULN (≤3×ULN if Gilbert's syndrome) II. Renal: Serum creatinine ≤1.5×ULN; Calculated CrCl: ≥40 mL\u002Fmin (Cockcroft-Gault \\[adults\\]; Schwartz formula \\[adolescents\\]; apply if serum creatinine is borderline) III. Cardiac: ejection fraction ≥ 50% and no evidence of pericardial effusion as determined by ECHO IV. Hematologic: WBC count must be ≤20 × 10⁹\u002FL prior to the first dose of study treatment and before each dose in Cycle 1; patients with WBC \\>20 × 10⁹\u002FL may receive cytoreduction with hydroxyurea (up to 4 g\u002Fday) and\u002For leukapheresis per protocol to achieve this threshold, with hydroxyurea held ≥12-24 hours before each study treatment dose 5. Females of childbearing potential must have a negative serum or urine pregnancy test 6. Adults: written informed consent. Adolescents: written patient assent plus parental\u002Fguardian informed consent.\n\n   7\\. Prior treatment with an investigational agent is permitted provided that at least 5 half-lives have elapsed and all treatment-related toxicities have resolved to Grade ≤1 (except alopecia). Prior T-cell engaging, checkpoint inhibitor, or cellular therapies require a minimum washout of 8 weeks.\n\n   Exclusion Criteria:\n   * 1\\. Active central nervous system (CNS) disease requiring treatment. 2. Uncontrolled or clinically significant baseline neurologic disorder (e.g., uncontrolled seizures or severe cognitive impairment\u002Fdelirium), significant psychiatric illness or active substance abuse.\n\n     3\\. Uncontrolled infections including persistent bacteremia\u002Ffungemia despite appropriate therapy, progressive invasive fungal infection, or uncontrolled viral infection with end-organ disease. Active tuberculosis.\n\n     4\\. Concurrent malignancy requiring active systemic therapy. 5. Cytotoxic chemotherapy within 14 days prior to first dose. Targeted anti-leukemic therapy within 7-14 days prior to first dose. Radiotherapy within 14 days prior to first dose (except limited-field palliative radiotherapy). Prior CD3-engaging therapy.\n\n     6\\. T-cell depleting therapy (ATG, alemtuzumab, or equivalent) within 6 months prior to enrollment 7. Severe uncontrolled cardiovascular disease (e.g., NYHA class III\u002FIV heart failure, unstable angina or MI within 6 months, uncontrolled arrhythmia). Severe uncontrolled pulmonary disease (e.g., requiring high-flow oxygen or ventilatory support).\n\n     8\\. Systemic corticosteroids \\>10 mg\u002Fday prednisone equivalent within 7 days prior to first dose.\n\n     9\\. Active autoimmune disease requiring systemic immunosuppression within the past 12 months.\n\n     10\\. Prior allogeneic transplant within 3 months or active graft-versus-host disease (GVHD).\n\n     11\\. Primary immunodeficiency (congenital immunodeficiency disorder requiring ongoing medical management).\n\n     12\\. Known HIV infection. Hepatitis B: HBsAg positive (chronic HBV infection). Hepatitis C: anti-HCV positive (HCV exposure).\n\n     13\\. Pregnant or breastfeeding 14. Known congenital or acquired bleeding disorder, including hemophilia A\u002FB or von Willebrand disease, or other clinically significant coagulopathy 15. History of severe allergic reaction to immunotherapy","6 Months",{"count":174,"type":22},108,[89,58],"About this study\n\nThis is the first study of VTRU200 in people. The main purpose of this study is to find a safe dose of VTRU200 and learn how the medicine behaves in the body. Researchers will also look for early signs that it may help treat cancer.\n\nVTRU200 is an experimental immunotherapy. It is designed to help the body's immune system find and destroy cancer cells while limiting effects on healthy cells.\n\nUnlike many cancer treatments that target a single protein, VTRU200 recognizes stress signals that are commonly found on cancer cells. These signals include certain sugars (called glycans) and fats (called phospholipids) that are present on many types of cancer cells but are uncommon on normal healthy cells. VTRU200 also attaches to immune cells called T cells and helps direct them to attack cancer cells.\n\nBecause VTRU200 targets features that are shared by many cancers, it may continue to work even if cancer cells lose or change individual proteins that other treatments depend on.\n\nWho can take part?\n\nThis study is for people with certain blood cancers that have come back after treatment or have not responded to available treatments. These include:\n\nAcute myeloid leukemia (AML) Higher-risk myelodysplastic syndromes (HR-MDS) Diffuse large B-cell lymphoma (DLBCL) that has returned after CAR T-cell therapy\n\nLater parts of the study may also include adolescents and children with AML.\n\nWhat will happen during the study?\n\nParticipants will receive VTRU200 through a vein (intravenous infusion).\n\nThe study will begin by giving small doses to help determine the safest dose for future participants. If those doses are well tolerated, later participants may receive higher doses.\n\nResearchers will:\n\nMonitor participants closely for side effects. Perform blood tests to measure how VTRU200 moves through and leaves the body. Measure how the immune system responds to treatment. Check whether the cancer shrinks, disappears, or remains under control.\n\nParticipants may receive multiple treatment cycles if they continue to benefit and do not have unacceptable side effects.\n\nWhat are the possible benefits?\n\nVTRU200 may or may not help participants. Information learned from this study may help develop new treatments for people with these cancers in the future.\n\nWhat are the possible risks?\n\nBecause VTRU200 is being tested in humans for the first time, not all side effects are known.\n\nPossible risks include reactions related to activation of the immune system, infusion-related reactions, laboratory test changes, and other side effects. Participants will be monitored closely throughout the study, and medical care will be available if side effects occur.\n\nBrief Study Description\n\nThis first-in-human, open-label, Phase 1\u002F2a study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary antitumor activity of VTRU200 in participants with relapsed or refractory acute myeloid leukemia (AML), higher-risk myelodysplastic syndromes (HR-MDS), or diffuse large B-cell lymphoma (DLBCL) following CAR T-cell therapy. VTRU200 is an investigational trispecific T-cell engager that binds stress-associated glycans, phosphatidylserine, and CD3 to redirect T cells toward cancer cells. The Phase 1 dose-escalation portion will determine the recommended Phase 2 dose (RP2D), followed by disease-specific expansion cohorts to further evaluate safety and preliminary antitumor activity.\n\nWhy is this research important?\n\nMany blood cancers eventually stop responding to available treatments. Cancer cells can escape therapy by changing or losing the proteins that many current medicines target.\n\nVTRU200 is designed to recognize stress-related features that many cancer cells share rather than relying on a single protein target. Researchers hope this approach may reduce the chance of treatment resistance while limiting damage to healthy cells. This study will help determine whether VTRU200 can be given safely and whether it shows early signs of helping people with difficult-to-treat blood cancers.",[178,97,179,180,181],"Acute Myeloid Leukemia","High Risk Myelodysplastic Syndrome","Solid Tumor Malignancies","Pediatric Acute Myeloid Leukemia",[183,184],"T cell engager","TCE","2026-08-03",{"date":187,"type":39},"2026-08-06",{"date":189,"type":22},"2027-01",{"date":191,"type":22},"2029-01",{"name":193,"class":46},"Vitruviae",{"id":195,"slug":196,"hasResults":12,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":4,"eligibilityCriteria":200,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":201,"enrollmentInfo":202,"targetDuration":4,"studyType":23,"phases":204,"briefSummary":205,"conditions":206,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":207,"startDateStruct":209,"completionDateStruct":210,"leadSponsor":212,"locationsCount":214},"100647667","phase-2-birelentinib-plus-r-chop-in-patients-with-newly-diagnosed-diffuse-large-b-cell-lymphoma-tai-shan19-100647667","NCT07712588","Birelentinib Plus R-CHOP in Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma (TAI-SHAN19)","A Phase 2\u002F3, Randomized, Double-Blind, Multi-center Study of Birelentinib Combined With R-CHOP in Patients With Newly Diagnosed Diffuse Large B-Cell Lymphoma","Inclusion Criteria:\n\n* Age 18-70 years\n* ECOG score 0-2\n* Pathologically confirmed DLBCL unspecified (DLBCL, NOS)\n* No prior anti-lymphoma therapy\n* Ann Arbor Stages II - IV\n* IPI score ≥ 3, or IPI score 1 - 2 and LDH \\> 1.3 × ULN and\u002For lesion diameter ≥ 7 cm\n* Adequate bone marrow and organ function\n* Willing to comply with contraceptive restrictions\n\nExclusion Criteria:\n\n* Indolent lymphoma or Richter transformation, primary mediastinal lymphoma, lymphoma invading the central nervous system or high-grade lymphoma with MYC and BCL2 rearrangements.\n* Vaccination with live attenuated vaccines or viral vector vaccines within 4 weeks prior to treatment.\n* Taking vitamin K antagonists, taking 2 or more antiplatelet\u002Fanticoagulant drugs at the same time, drugs\u002Fherbs or supplements known to potently induce or inhibit CYP3A enzyme activity, anti-tumor traditional Chinese medicine.\n* Major surgery within 4 weeks or anticipated surgery after the start of this study.\n* Clinically significant cardiac disorders. History of thrombotic diseases, stroke or intracranial hemorrhage within 6 months.\n* Active infectious diseases.\n* Peripheral neuropathy ≥ Grade 2 (as defined by CTCAE version 6.0)\n* Intractable nausea and vomiting that cannot be well controlled by supportive treatment, chronic gastrointestinal diseases, dysphagia, or previous surgical resection of the intestinal segment may affect the adequate absorption of the drug.\n* Diagnosed with other malignant diseases other than B-cell lymphoma within the past 2 years.\n* Patients with severe or uncontrolled systemic diseases, including poorly controlled hypertension and active bleeding constitution.\n* Patients with a history of hypersensitivity to any component of the R-CHOP regimen, DZD8586 drug excipients, or other chemical analogues.\n* Serious medical or psychiatric illness that could affect participation in the study or could compromise the ability to consent.\n* Women who are pregnant or breastfeeding.","70 Years",{"count":203,"type":22},880,[58,25],"This study will treat patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL). It will assess the anti-tumor efficacy and safety of birelentinib plus rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) vs placebo plus R-CHOP.",[63],{"date":208,"type":39},"2026-08-05",{"date":160,"type":22},{"date":211,"type":22},"2032-02",{"name":213,"class":46},"Dizal Pharmaceuticals",5,{"id":216,"slug":217,"hasResults":12,"nctId":218,"briefTitle":219,"officialTitle":220,"acronym":221,"eligibilityCriteria":222,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":223,"targetDuration":4,"studyType":23,"phases":225,"briefSummary":226,"conditions":227,"keywords":236,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":241,"lastUpdatePostDateStruct":242,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":250},"100607438","phase-3-a-study-to-investigate-ronde-cel-versus-investigators-choice-cd19-car-t-cell-therapy-100607438","NCT07188558","A Study to Investigate Ronde-cel Versus Investigator's Choice CD19 CAR T-Cell Therapy","A Phase 3 Randomized Controlled Trial of Rondecabtagene Autoleucel , an Autologous, Dual-targeting CD19\u002FCD20 CAR T-Cell Product Candidate, Vs. Investigator's Choice of CD19 CAR T-Cell Therapy in Patients With Relapsed or Refractory Large B-Cell Lymphoma in the Second-line Setting","PiNACLE-H2H","Key Inclusion Criteria:\n\n1. CAR T cell naïve and eligible to receive a CD19 CART-cell therapy\n2. Histologically confirmed large B-cell lymphoma, including the following types defined by (WHO 2022) or International Consensus Classification (2022)\n\n   * Diffuse large B-cell lymphoma (DLBCL)\n   * Transformations of indolent B-cell lymphomas (excluding Richter's transformation)\n   * DLBCL\u002FHigh-grade B-cell lymphoma (HGBCL) with MYC and BCL2 rearrangements\n   * High-grade B-cell lymphoma (HGBCL) not otherwise specified (HGBCL NOS)\n   * Primary mediastinal large B-cell lymphoma (PMBCL)\n   * Grade 3B follicular lymphoma\u002Flarge cell follicular lymphoma (FL3B)\n3. Relapsed or refractory disease after anti-CD20 antibody and anthracycline-containing first-line chemoimmunotherapy\n4. Measurable disease by presence of \\[18F\\]-fluorodeoxyglucose PET\u002FCT positive lesion during Screening per Lugano Criteria\n5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n6. Adequate hematological, renal, hepatic, pulmonary, and cardiac function\n\nKey Exclusion Criteria:\n\n1. Patients ineligible to receive CD19 CAR T-cell therapy\n2. Primary CNS lymphoma\n3. Patients with primary cutaneous LBCL, human herpes virus-8 positive lymphoma, Burkitt lymphoma, T cell histiocyte-rich lymphoma, or transformation from chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma (Richter's transformation)\n4. Patients with prior history of malignancy, other than aggressive relapsed or refractory LBCL, unless the patient has been free of the disease for ≥ 2 years\n5. Patients with uncontrolled systemic fungal, bacterial, viral, or other infection (including tuberculosis) despite appropriate antibiotics or other treatment\n6. Active autoimmune disease requiring ongoing systemic immunosuppressive therapy.\n\nNote: Other protocol defined Inclusion\u002FExclusion criteria may apply",{"count":224,"type":22},400,[25],"This Phase 3 study compares rondecabtagene autoleucel (ronde-cel), a dual-targeting CD19\u002FCD20 CAR T-cell therapy, with investigator's choice of CD19 CAR T-cell therapy in patients with relapsed or refractory large B-cell lymphoma in the second-line setting.",[228,229,230,231,232,233,97,234,235],"Large B-cell Lymphoma","Lymphoma, B-Cell","Relapsed Non-Hodgkin Lymphoma","Refractory Non-Hodgkin Lymphoma","Non-Hodgkin Lymphoma","Non-Hodgkin Lymphoma Refractory\u002F Relapsed","Diffuse Large B Cell Lymphoma Refractory","Diffuse Large B Cell Lymphoma Relapsed",[237,232,238,239,240,228],"Lymphoma","CAR T-Cell Therapy","CD19","CD19\u002FCD20","2026-07-31",{"date":243,"type":39},"2026-08-04",{"date":245,"type":39},"2026-01-12",{"date":247,"type":22},"2032-01",{"name":249,"class":46},"Lyell Immunopharma, Inc.",36,{"id":252,"slug":253,"hasResults":12,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":4,"eligibilityCriteria":257,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":258,"targetDuration":4,"studyType":23,"phases":260,"briefSummary":261,"conditions":262,"keywords":265,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":278},"100642551","phase-1-a-study-of-rocbrutinib-in-combination-with-lacutoclax-in-patients-with-b-cell-malignancies-100642551","NCT07609862","A Study of Rocbrutinib in Combination With Lacutoclax in Patients With B-Cell Malignancies","A Phase Ib\u002FII, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BTK Inhibitor Rocbrutinib in Combination With BCL-2 Inhibitor Lacutoclax in Patients With B-Cell Malignancies","Inclusion Criteria:\n\n1. Age ≥18 years, regardless of sex.\n2. Ib: Histologically confirmed diagnosis of CLL\u002FSLL (per 2018 iwCLL criteria) or B-cell malignancies (per 2022 WHO classification), including: MCL, DLBCL, FL, and WM. Must have received at least one prior line of systemic therapy, with documented disease progression or intolerance.\n\n   II: For Treatment-naïve (TN) CLL\u002FSLL patients: Must meet iwCLL treatment indications and no prior systemic therapy. For R\u002FR CLL\u002FSLL patients: at least one prior systemic therapy with documented disease progression or intolerance.\n3. Have at least one measurable lesion.\n4. Phase Ib: ECOG performance status ≤1; phase II: ECOG performance status ≤2.\n5. Life expectancy ≥ 12 weeks.\n6. Adequate coagulation function, liver and kidney function, bone marrow hematopoietic function.\n7. Male patients and female patients of childbearing potential must agree to use effective contraception during the study and for 90 days after the last dose of study treatment. Female patients of childbearing potential must have a negative pregnancy test before study treatment and must not be breastfeeding. Male patients must not donate sperm during the study and for 90 days after the last dose.\n8. Participation is voluntary, requiring signed informed consent and compliance with the treatment regimen and visit schedule.\n\nExclusion Criteria:\n\n1. Known hypersensitivity or intolerance to Rocbrutinib, Lacutoclax, or any of their excipients; prior treatment with any BCL-2 inhibitor; or prior treatment with both covalent and non-covalent BTK inhibitors.\n2. Use of systemic corticosteroids at doses equivalent to \\>20 mg\u002Fday of prednisone for ≥3 days within 7 days prior to the first dose.\n3. History of or currently suspected Richter's syndrome.\n4. Known or suspected central nervous system (CNS) involvement.\n5. Prior allogeneic hematopoietic stem cell transplantation (allo-HSCT), or autologous hematopoietic stem cell transplantation (auto-HSCT) or chimeric antigen receptor T-cell (CAR-T) therapy within 90 days before the first dose of study treatment.\n6. Received antitumor therapy, investigational agents, major surgery, severe trauma, or live attenuated vaccines within 4 weeks or 5 half-lives prior to the first dose of study treatment.\n7. Received herbal medicines for antitumor treatment, or localized radiotherapy within 14 days prior to the first dose of study treatment.\n8. Use of moderate or strong CYP3A inhibitors within 7 days prior to the first dose of study treatment, or consumption of grapefruit, grapefruit juice, starfruit, or Seville oranges within 3 days prior to prior to the first dose.\n9. History of other active malignancies within the past 3 years, except for curatively treated basal cell carcinoma, localized squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or other malignancies considered cured.\n10. Any severe and\u002For uncontrolled systemic disease, or any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in the study.\n11. Any of the following events within 6 months prior to the first dose: Symptomatic arrhythmia, myocardial infarction, intracranial hemorrhage, or Stroke.\n12. Impaired cardiac function.\n13. Any uncontrolled systemic infection.\n14. Conditions that may impair oral drug administration or significantly affect absorption or pharmacokinetics of the study drug.\n15. Unable to discontinue moderate or strong CYP3A inhibitors or inducers, P-gp (P-glycoprotein) inhibitors, sensitive substrates of OATP1B3 or CYP2C8 during the study period.\n16. Received vaccination with any live-attenuated vaccines within 4 weeks prior to the first dose of study treatment.\n17. Evidence of an active bleeding constitution or a history of significant hemorrhagic disorders.\n18. Requirement for ongoing therapy with warfarin or other vitamin K antagonists.\n19. Presence of an active, uncontrolled, or symptomatic autoimmune disease that requires systemic treatment.\n20. Any other condition that, in the investigator's judgment, makes the patient unsuitable for study participation.",{"count":259,"type":22},92,[89,58],"BTK inhibitors and BCL-2 inhibitors have demonstrated significant clinical activity in mature B-cell malignancies, and combination therapy may provide improved clinical benefit. This is a multi-center, open-label, single-arm Phase Ib\u002FII clinical study. The purpose of this clinical trial is to investigate the safety, tolerability, pharmacokinetics, and preliminary efficacy of Rocbrutinib, a fourth-generation Bruton tyrosine kinase inhibitor (BTKi), in combination with the BCL-2 inhibitor Lacutoclax in patients with mature B-cell malignancies. The Phase Ib will use a classic 3+3 dose-escalation design to evaluate dose-limiting toxicities (DLTs), determine the maximum tolerated dose (MTD), and identify the recommended dosing regimen. The Phase II portion is intended to further evaluate the efficacy and safety of the combination therapy.",[126,63,263,264,123],"Follicular Lymphoma ( FL)","Waldenström Macroglobulinemia (WM)",[266,267,268],"mature B-cell malignancies","BTK inhibitor","BCL-2 inhibitor","2026-07-29",{"date":271,"type":39},"2026-07-30",{"date":273,"type":39},"2026-07-14",{"date":275,"type":22},"2033-05-30",{"name":277,"class":46},"Guangzhou Lupeng Pharmaceutical Company LTD.",1,{"id":280,"slug":281,"hasResults":12,"nctId":282,"briefTitle":283,"officialTitle":284,"acronym":4,"eligibilityCriteria":285,"healthyVolunteers":12,"sex":18,"minAge":149,"maxAge":4,"enrollmentInfo":286,"targetDuration":4,"studyType":23,"phases":288,"briefSummary":289,"conditions":290,"keywords":291,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":293,"lastUpdatePostDateStruct":294,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":278},"100623530","phase-2-crp-regimen-in-treating-elderly-patients-with-previously-untreated-double-positive-dlbcl-100623530","NCT07397832","CRP Regimen in Treating Elderly Patients With Previously Untreated Double-Positive DLBCL","CRP Regimen (Chidamide, Rituximab and Polatuzumab Vedotin) in Treating Elderly Patients With Previously Untreated Double-Positive DLBCL: Single-Arm, Open-Label, Multicenter Phase II Trial","Inclusion Criteria:\n\n1. Patients aged ≥70 years, or patients aged 60-69 years with an ECOG performance status score of 2-4. Both males and females are eligible.\n2. No prior treatment for DLBCL, including chemotherapy, targeted therapy, immunotherapy, local radiotherapy directed at the lymphoma (excluding palliative radiotherapy for symptom relief), or surgical therapy (excluding diagnostic biopsy or surgery not targeting the lymphoma).\n3. Histopathological confirmation meeting all of the following conditions:\n\n   1. Diagnosis of diffuse large B-cell lymphoma (DLBCL) with CD20 positivity; concurrent positive expression of C-MYC and Bcl-2 (double-expressor phenotype).\n   2. At least one measurable lesion positive on ¹⁸F-FDG PET-CT scan according to the Lugano 2014 criteria for Hodgkin and non-Hodgkin lymphoma.\n4. Laboratory tests at screening must meet the following criteria, unless the investigator attributes abnormalities to lymphoma (no corrective or supportive therapy for these parameters within 2 weeks prior to assessment):\n\n   1. Hematology: Hb ≥90 g\u002FL, ANC ≥1.5 × 10⁹\u002FL, PLT ≥90 × 10⁹\u002FL.\n   2. Biochemistry: Cr ≤1.5 ×ULN; TBIL ≤1.5 × ULN; ALT and AST ≤2.5 × ULN (for patients with liver involvement: ≤5 × ULN).\n5. Life expectancy of at least 6 months, as judged by the investigator.\n6. Ability to understand and voluntarily provide written informed consent.\n\nExclusion Criteria:\n\n1. History of or concurrent other active malignancies.\n2. Prior treatment with Chidamide and\u002For R-CHOP. Contraindication to any component of CHOP, including prior anthracycline therapy. History of severe hypersensitivity or anaphylaxis to humanized or murine monoclonal antibodies, or known sensitivity\u002Fallergy to murine products.\n3. Current diagnosis of any of the following: Follicular lymphoma grade 3B; B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma (grey zone lymphoma); Primary mediastinal (thymic) large B-cell lymphoma; Burkitt lymphoma; Central nervous system (CNS) lymphoma (primary or secondary); Primary effusion DLBCL; Primary cutaneous DLBCL, leg type.\n4. History of myocardial infarction, unstable angina, or other clinically significant cardiac disease within 12 months prior to signing informed consent; or prior coronary angioplasty\u002Fstenting within 12 months.\n5. Clinically uncontrolled active infection (bacterial, fungal, or viral) or organ hemorrhage.\n6. Pregnant or lactating women.\n7. Participation in any other clinical trial within 6 months prior to signing informed consent.\n8. Any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in this study.",{"count":287,"type":22},58,[58],"A Single-Arm, Open-Label, Multicenter Phase II Trial of CRP Regimen (Chidamide, Rituximab, Polatuzumab Vedotin) in Treating Elderly Patients with Previously Untreated Double-Positive Diffuse Large B-Cell Lymphoma",[63],[292],"Diffuse Large B-Cell Lymphoma","2026-07-28",{"date":269,"type":39},{"date":296,"type":39},"2026-02-03",{"date":298,"type":22},"2028-12-30",{"name":300,"class":77},"Tianjin Medical University Cancer Institute and Hospital",{"id":302,"slug":303,"hasResults":12,"nctId":304,"briefTitle":305,"officialTitle":306,"acronym":4,"eligibilityCriteria":307,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":308,"targetDuration":4,"studyType":23,"phases":310,"briefSummary":311,"conditions":312,"keywords":314,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":326,"locationsCount":278},"100641249","phase-2-the-cardioprotect-trial-100641249","NCT07654426","The CARDIOPROTECT Trial","A Randomized Study of Dexrazoxane or Liposomal Doxorubicin in Newly Diagnosed Diffuse Large B-cell Lymphoma at High Risk for Heart Failure Events: the CARDIOPROTECT Trial","Inclusion Criteria:\n\n* Participants must have histologically confirmed diffuse large B-cell lymphoma, histologically transformed large B cell lymphoma from a prior indolent lymphoma, or other high-grade B-cell lymphoma for which R-CHOP or pola-R-CHP are planned. Any cancer stage is permitted.\n* Participants must not have received any prior chemotherapy for this malignancy. Pre-phase steroids are allowed. Prior treatment for a different malignancy is allowed, including prior treatment for indolent lymphoma.\n* Age ≥18 years. Diffuse large B cell lymphoma is rare in participants \\\u003C18 years of age. The prevalence of HF prior to chemotherapy is also exceedingly rare in participants \\\u003C18 years of age; therefore, participants \\\u003C18 years of age are excluded from this study.\n* Participants must have ONE or more of the following risk factors for HF events with anthracycline-containing chemotherapy\n\n  1. LVEF 30-50% on most recent echocardiogram with or without HF history\n  2. LVEF 50% with a history of HF (i.e. HF with improved EF or HF with preserved EF).\n  3. History of anthracycline exposure for different malignancy.\n* Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.\n* Because dexrazoxane as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of chemotherapy administration.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* New York Heart Association (NYHA) Class III or IV exertional dyspnea. The symptoms should be attributed to HF and not due to lymphoma, anemia, arthritis or other causes per the assessment of the treating clinician or study investigator. NYHA Class III defined as: \"Marked limitations with less than ordinary activity such as walking short distances or climbing a few stairs\" and NYHA Class IV defined as: \"Inability to carry out any activity without discomfort. Symptoms are present at rest and if any physical activity is undertaken the symptoms are increased.\" (see Appendix A for NYHA Classification).\n* LVEF \\\u003C30% on most recent echocardiogram. Patients with prior LVEF \\\u003C30% with improvement to \\>30% on most recent echocardiogram are eligible.\n* Meeting criteria for frailty according to the simplified geriatric assessment (see Appendix A for the simplified geriatric assessment criteria).\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to any agents used in study.\n* Presence of central nervous system involvement\n* Presence of concurrent genetic rearrangements of the MYC and BCL2 genes, so called \"double-hit\" large-cell lymphoma who are not deemed eligible for intensified induction chemotherapy such as dose adjusted EPOCH-R by their treating physician can be enrolled\n* Ineligible for R-CHOP or pola-R-CHP because of liver disease per institutional policies\n* Patients with planned dose reductions from the first cycle ie R-mini-CHOP will be excluded\n* There are no contraindicated medications. Caution and monitoring are advised with medications that can cause myelosuppression.\n* Patients with positive Hepatitis B core antibody can be enrolled if they have negative viral load and can be maintained on antiviral prophylaxis\n* Patients with HIV can be enrolled if they have anti-retroviral therapy options without drug-drug interactions with the cancer treatment, agree to take anti-retroviral therapy and do not have uncontrolled opportunistic infections.\n* Pregnant women are excluded from this study because dexrazoxane and liposomal doxorubicin are agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with dexrazoxane and liposomal doxorubicin, breastfeeding should be discontinued if the mother is treated with dexrazoxane and liposomal doxorubicin. These potential risks may also apply to other agents used in this study.\n* Eligibility for observational arm of the study. The above inclusion and exclusion criteria are for the randomized trial. Patients who meet the inclusion criteria but have one or more exclusion criterion are eligible to participate in the observational arm of the study. In addition, patients who meet all eligibility criteria for the randomized trial but decline participation in the randomized trial are also eligible to participate in the observational arm of the study.",{"count":309,"type":22},60,[58],"This trial is to evaluate if dexrazoxane is safer and more effective than liposomal doxorubicin in preventing heart failure events in participants with diffuse large B-cell lymphoma (DLBCL) undergoing either standard of care R-CHOP or pola-R-CHP treatment regiments.\n\nThe names of the study drugs involved in this study are:\n\n* Dexrazoxane (a type of Topoisomerase II Inhibitor)\n* Liposomal Doxorubicin (a type of Topoisomerase II Inhibitor)\n* Standard of care R-CHOP treatment regimen (Cyclophosphamide, doxorubicin, vincristine, prednisone, rituximab)\n* Standard of care pola-R-CHP treatment regimen: Cyclophosphamide, doxorubicin, polatuzumab vedotin-piiq, prednisone, rituximab",[28,313,237],"Cardiotoxicity",[28,315,313,237,316,317,318],"High Risk for Heart Failure Events","Stage B Heart Failure","Stage C Heart Failure","Left ventricular ejection fraction (LVEF) decline","2026-07-24",{"date":321,"type":39},"2026-07-27",{"date":323,"type":22},"2026-08-31",{"date":325,"type":22},"2035-12-31",{"name":327,"class":77},"Beth Israel Deaconess Medical Center",{"id":329,"slug":330,"hasResults":12,"nctId":331,"briefTitle":332,"officialTitle":332,"acronym":333,"eligibilityCriteria":334,"healthyVolunteers":12,"sex":18,"minAge":335,"maxAge":336,"enrollmentInfo":337,"targetDuration":4,"studyType":23,"phases":339,"briefSummary":340,"conditions":341,"keywords":346,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":359,"startDateStruct":360,"completionDateStruct":362,"leadSponsor":364,"locationsCount":278},"100648944","phase-1-autologous-ic-nine-cd30-car-and-constitutive-il7r-expressing-ebvst-for-cd30-lymphoma-ancile-30-100648944","NCT07729397","Autologous IC-Nine, CD30 CAR, and Constitutive IL7R Expressing EBVST for CD30 Lymphoma (ANCILE-30)","ANCILE-30","Procurement Inclusion Criteria:\n\nParticipants must meet the protocol-defined procurement eligibility criteria before collection of peripheral blood mononuclear cells for manufacture of the investigational product, including:\n\n1. Diagnosis of relapsed or refractory Hodgkin lymphoma or non-Hodgkin lymphoma.\n2. CD30 positive tumor (can be pending at this time) as assayed in a CLIA certified Pathology Laboratory.\n3. Age 16 to 75 years.\n4. Hemoglobin ≥7.0(may be transfused value).\n5. Karnofsky or Lansky score of \\> 60%\n6. Informed consent explained to, understood by and signed by patient or guardian. Patient or guardian given copy of informed consent.\n\nProcurement Exclusion Criteria:\n\n1. Active HIV or HTLV infection (testing may be pending at procurement).\n2. Active bacterial, fungal, or viral infection.\n\n   \\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\\_\n\nTreatment Inclusion Criteria:\n\nParticipants with a successfully manufactured product must continue to satisfy the protocol-defined treatment eligibility criteria before receiving study treatment, including:\n\n1. Diagnosis and clinical course falling into one of the following categories:\n\n   * Hodgkin lymphoma\n   * CD30+ aggressive B-cell lymphoma\n   * ALK-negative anaplastic T cell lymphoma or other peripheral T- cell lymphoma\n   * ALK-positive anaplastic T cell lymphoma\n2. CD30 expression confirmed in a CLIA-certified laboratory. Recovered from all acute non-hematologic toxic effects of all prior chemotherapy\n3. Age 16 to 75 years.\n4. Bilirubin ≤ 2 times the upper limit of normal (except for Gilbert syndrome, where the criteria will be Bilirubin ≤ 3 times the upper limit of normal).\n5. AST ˂ 3 times the upper limit of normal\n6. Estimated GFR \\> 50 mL\u002Fmin\n7. Pulse oximetry of \\> 90% on room air\n8. Karnofsky or Lansky score of \\> 60%\n9. Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after study is concluded. Male partner should use a condom\n10. Informed consent explained to, understood by and signed by patient\u002Fguardian. Patient\u002FGuardian given copy of informed consent.\n\nTreatment Exclusion Criteria:\n\n1. Received an investigational cell therapy or vaccine within the past 6 weeks.\n2. Received an investigational small molecule within the past 2 weeks.\n3. Received anti-CD30 antibody-based therapy within the previous 4 weeks.\n4. History of hypersensitivity reactions to murine protein-containing products\n5. Pregnancy or breastfeeding.\n6. Tumor in a location where enlargement could cause airway obstruction (determined at the investigators' discretion)\n7. Current use of systemic corticosteroids at a dose equivalent to higher than 10 mg\u002Fday of prednisone.\n8. Active significant, uncontrolled bacterial, viral or fungal infection.\n9. Symptomatic cardiac disease (NYHA Class III or IV disease).","16 Years","75 Years",{"count":338,"type":22},21,[89],"This Phase I study will evaluate the safety of autologous Epstein-Barr virus-specific T lymphocytes modified to express a constitutively active IL7 receptor (C7R) and a chimeric antigen receptor (CAR) for CD30 (C7R.CD30-CAR-EBVSTs) in patients with relapsed or refractory CD30-positive lymphomas.\n\nParticipants who meet procurement eligibility criteria will undergo collection of peripheral blood mononuclear cells for manufacture of the investigational product. Participants with a successfully manufactured product who continue to meet treatment eligibility criteria will receive lymphodepleting chemotherapy followed by infusion of autologous C7R.CD30-CAR-EBVSTs.\n\nThe primary objective is to evaluate safety. Secondary and exploratory objectives include evaluation of antitumor effect, expansion and persistence of the infused cells, and the association between immunological parameters, safety, and clinical response.",[63,342,343,344,345],"Hodgkin Lymphoma","Peripheral T-cell Lymphoma (PTCL)","Anaplastic Large Cell Lymphoma, ALK-Positive","Anaplastic Large Cell Lymphoma, ALK-Negative",[347,348,349,350,351,352,353,354,355,356,357],"CD30","Chimeric Antigen Receptor","CAR T Cells","Epstein-Barr Virus-Specific T Lymphocytes","EBVST","Constitutive IL7 Receptor","C7R","Gene Therapy","Cell Therapy","iC9","Inducible Caspase 9","2026-07-22",{"date":321,"type":39},{"date":361,"type":22},"2027-01-15",{"date":363,"type":22},"2044-02-28",{"name":365,"class":77},"The Methodist Hospital Research Institute",{"id":367,"slug":368,"hasResults":12,"nctId":369,"briefTitle":370,"officialTitle":371,"acronym":4,"eligibilityCriteria":372,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":373,"enrollmentInfo":374,"targetDuration":4,"studyType":23,"phases":375,"briefSummary":376,"conditions":377,"keywords":379,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":383,"lastUpdatePostDateStruct":384,"startDateStruct":385,"completionDateStruct":387,"leadSponsor":389,"locationsCount":278},"100630968","phase-2-celecoxib-plus-r-chop-vs-r-chop-in-newly-diagnosed-advanced-cd5-dlbcl-100630968","NCT07494565","Celecoxib Plus R-CHOP vs R-CHOP in Newly Diagnosed Advanced CD5+ DLBCL","A Multicenter, Prospective, Randomized, Open-Label, Phase II Study of Celecoxib Combined With R-CHOP Versus R-CHOP in Patients With Newly Diagnosed Advanced CD5-Positive Diffuse Large B-Cell Lymphoma (CD5+ DLBCL)","Inclusion Criteria:\n\n1. Age ≥ 18 years and ≤ 80 years, either gender, life expectancy \\> 6 months.\n2. Histopathologically confirmed diffuse large B-cell lymphoma (DLBCL), CD20-positive, and immunohistochemically CD5-positive .\n\n   Note: Patients must provide a local pathological report before screening or sufficient fresh or paraffin-embedded tissue to confirm the CD5+ IHC result.\n3. No prior therapy for DLBCL, including chemotherapy, targeted therapy, immunotherapy, local radiotherapy for lymphoma (except palliative local radiotherapy for tumor-related symptoms), or surgical treatment (except tumor\u002Fpathologic biopsy and non-lymphoma-directed surgical resection).\n4. At least one assessable or measurable lesion according to the Lugano 2014 criteria:\n\n   * Lymph node lesion: longest diameter \\> 1.5 cm;\n   * Extranodal lesion: longest diameter \\> 1.0 cm.\n5. International Prognostic Index (IPI) score 0-5, stage III-IV disease.\n6. ECOG performance status 0-2.\n7. Laboratory results must meet the following criteria prior to the first dose:\n\n   \\- Bone marrow function: WBC ≥ 3×10⁹\u002FL, HGB ≥ 90 g\u002FL, ANC ≥ 1.5×10⁹\u002FL, PLT ≥ 80×10⁹\u002FL;\n   * Liver function: TBIL ≤ 1.5×ULN; ALT or AST ≤ 2.5×ULN (≤ 5×ULN if liver involvement); ALP ≤ 3×ULN in patients without bone involvement;\n   * Renal function: serum creatinine ≤ 1.5×ULN, or estimated glomerular filtration rate ≥ 50 mL\u002Fmin by the Cockcroft-Gault equation;\n   * PT, APTT, INR ≤ 1.5×ULN unless receiving anticoagulation.\n8. Left ventricular ejection fraction (LVEF) ≥ 50% by echocardiography at screening.\n9. Female patients of childbearing potential must have a negative serum or urine pregnancy test within 7 days before enrollment, agree to use effective contraception during study participation and for ≥ 12 months after the last dose.\n\nMale patients must agree to use effective contraception during study participation and for ≥ 3 months after the last dose.\n\n10\\. Understand and voluntarily provide written informed consent.\n\n\\---\n\nExclusion Criteria:\n\n1. History of primary or secondary central nervous system (CNS) lymphoma or CNS lymphoma involvement.\n2. Current or previous diagnosis of the following lymphoma subtypes: primary CNS DLBCL, primary mediastinal (thymic) large B-cell lymphoma, primary effusion DLBCL, double-hit DLBCL with BCL2 and MYC rearrangements, B-cell lymphoma unclassifiable with features intermediate between DLBCL and classic Hodgkin lymphoma\u002FBurkitt lymphoma (gray-zone lymphoma), primary cutaneous DLBCL, indolent lymphoma, Burkitt lymphoma, EBV-positive mucocutaneous ulcer, DLBCL associated with chronic inflammation, lymphomatoid granulomatosis, intravascular large B-cell lymphoma, ALK-positive large B-cell lymphoma, plasmablastic lymphoma, HHV8-positive DLBCL NOS, primary testicular lymphoma.\n3. Transformed lymphoma derived from other lymphoma types, including follicular lymphoma, marginal zone B-cell lymphoma, and chronic lymphocytic leukemia\u002Fsmall lymphocytic lymphoma.\n4. Previous organ transplantation or hematopoietic stem cell transplantation.\n5. Other malignancy diagnosed within 5 years prior to the first dose or concurrent malignancy, \\*\\*except\\*\\*:\n\n   other malignancy treated with surgery alone and achieving disease-free survival (DFS) for 5 consecutive years; cured carcinoma in situ of the cervix, non-melanoma skin cancer, and superficial bladder cancer \\[Ta (non-invasive tumor), Tis (carcinoma in situ), T1 (tumor invades lamina propria)\\].\n6. Previous treatment with cytotoxic agents for other diseases (e.g., rheumatoid arthritis) within 5 years prior to the first dose, or previous use of any anti-CD20 antibody.\n7. Previous use of any monoclonal antibody within 3 months prior to the first dose.\n8. Participation in another interventional clinical trial within 3 months prior to the first dose.\n9. Known hypersensitivity or contraindication to any study intervention, including:\n\n   * Contraindications to celecoxib, including hypersensitivity to celecoxib (e.g., known sulfonamide allergy, history of asthma, urticaria, or other allergic reactions induced by NSAIDs);\n   * Active peptic ulcer or gastrointestinal bleeding;\n   * Known hypersensitivity to rituximab or murine monoclonal antibody products;\n   * Contraindication to any component of the CHOP regimen, including previous anthracycline therapy;\n   * Diabetic patients unable to tolerate prednisone in the regimen.\n10. Use of glucocorticoids \\> 30 mg\u002Fday prednisone or equivalent for indications other than lymphoma symptom control:\n\n    \\- If receiving corticosteroid therapy ≤ 30 mg\u002Fday prednisone or equivalent, a stable dose must be documented for at least 4 weeks before Cycle 1 Day 1;\n\n    \\- If urgent glucocorticoid therapy (up to 100 mg prednisone or equivalent for a maximum of 7 days, Days -7 to -1) is required for lymphoma symptom control before the first dose, all tumor assessments must be completed before glucocorticoid initiation.\n\n    Major surgery (excluding diagnostic procedures) within 1 month prior to randomization.\n11. Severe peripheral or central nervous system disease, e.g., history of progressive multifocal leukoencephalopathy.\n12. Previous anti-DLBCL therapy, including chemotherapy, targeted therapy, immunotherapy, definitive radiotherapy with curative intent (except palliative non-curative radiotherapy), or surgical treatment (except biopsy).\n13. Adverse events from prior therapy not resolved to ≤ CTCAE Grade 1 (except Grade 2 peripheral neuropathy, alopecia, hypothyroidism controlled by hormone replacement, or type 1 diabetes mellitus well controlled with insulin).\n14. Administration of live attenuated viral vaccine within 1 month prior to enrollment.\n15. Uncontrolled infection (i.e., clinically unstable) requiring parenteral antibiotics, antivirals, or antifungals within 7 days before the first dose; prophylactic use is permitted.\n16. Active HBV infection or active HCV infection. Patients with controlled HBV\u002FHCV may be included cautiously at the investigator's discretion after effective antiviral intervention.\n17. HIV infection and\u002For acquired immunodeficiency syndrome.\n18. Inability to swallow tablets, malabsorption syndrome, or any other gastrointestinal disease or dysfunction that may interfere with study drug absorption.\n19. Significant cardiovascular disease, including any of the following:\n\n    \\- Cardiac insufficiency ≥ NYHA Class II, or LVEF \\\u003C 50% by echocardiography;\n\n    \\- History of clinically significant ventricular arrhythmias (e.g., sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes) or arrhythmia requiring continuous antiarrhythmic therapy;\n\n    \\- Myocardial infarction, serious arrhythmia, or unstable angina within 6 months before the first dose;\n\n    \\- History of clinically significant QTc prolongation, or QTc interval \\> 470 ms (females) \u002F \\> 450 ms (males) at screening;\n\n    \\- Other cardiovascular disease deemed inappropriate by the investigator;\n    * Uncontrolled hypertension despite combination therapy with 2 antihypertensive agents (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg on at least 2 measurements).\n20. Pulmonary fibrosis or interstitial pneumonia (except radiologic interstitial changes without symptoms or functional impairment), or history of pneumoconiosis, radiation pneumonitis, drug-induced pneumonitis, or severe pulmonary dysfunction.\n21. Arterial or venous thrombotic event within 6 months before the first dose, including cerebrovascular accident (cerebral hemorrhage, cerebral infarction, transient ischemic attack), deep vein thrombosis, pulmonary embolism.\n\nPatients with intermuscular vein thrombosis or infusion port-related thrombosis may be included if deemed low risk by the investigator.\n\n22\\. Renal failure requiring hemodialysis or peritoneal dialysis, or history of nephrotic syndrome.\n\n23\\. Current or previous autoimmune disease requiring treatment, except hypothyroidism on stable replacement therapy and type 1 diabetes mellitus.\n\n24\\. History of alcoholism or drug abuse. 25. Any other serious or unstable medical condition (other than excluded malignancies), psychiatric disorder, or condition that may compromise patient safety, informed consent, or compliance with study procedures, in the investigator's judgment.\n\n26\\. Pregnant or breastfeeding female patients, or fertile patients unwilling to use effective contraception.\n\n27\\. Patients deemed ineligible for the study by the investigator.\n\n\\---","80 Years",{"count":309,"type":22},[58],"To evaluate the efficacy of celecoxib combined with R-CHOP versus R-CHOP in the treatment of newly diagnosed advanced CD5-positive diffuse large B-cell lymphoma (CD5+ DLBCL).The primary endpoint is Complete Response Rate (CRR)",[63,378],"CD5 Positive",[380,381,382],"CD5+ DLBCL","Celecoxib","R-CHOP","2026-07-21",{"date":358,"type":39},{"date":386,"type":39},"2026-03-06",{"date":388,"type":22},"2029-05-05",{"name":390,"class":77},"Sun Yat-sen University",{"id":392,"slug":393,"hasResults":12,"nctId":394,"briefTitle":395,"officialTitle":396,"acronym":4,"eligibilityCriteria":397,"healthyVolunteers":12,"sex":18,"minAge":398,"maxAge":373,"enrollmentInfo":399,"targetDuration":4,"studyType":23,"phases":401,"briefSummary":402,"conditions":403,"keywords":404,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":383,"lastUpdatePostDateStruct":411,"startDateStruct":412,"completionDateStruct":414,"leadSponsor":416,"locationsCount":418},"100574902","phase-2-a-study-of-glofitamab-based-treatment-in-people-with-diffuse-large-b-cell-lymphoma-100574902","NCT06765317","A Study of Glofitamab-based Treatment in People With Diffuse Large B-cell Lymphoma","Optimizing Frontline Therapy for DLBCL in Older Adults: A GLOfitamab-based, Response-adapted, Window-stYle Study (GLORY)","Inclusion Criteria:\n\n1. Age 65-79 years with a fitness assessment of unfit or frail per simplified GA (Appendix 1, www.filinf.it\u002Fepi)\n2. Age ≥80 years with any fitness level\n3. Pathologically confirmed DLBCL, HGBCL or transformed lymphoma\n4. No prior systemic anti-lymphoma therapy (prednisone\u002Fequivalent up to 100 mg daily x 7 days is permissible)\n5. Ann Arbor Stage 2 bulky, 3 or 4 disease (Appendix 1)\n6. Any IPI score (Appendix 1)\n7. Anthracycline eligible: LVEF ≥ 45% by echocardiogram or MUGA scan.\n8. Must have at least one bi-dimensionally measurable lesion (\\>1.5 cm in its largest dimension for nodal lesions, or \\>1.0 cm in its largest dimension for extranodal lesions by computerized tomography \\[CT\\] scan or MRI)\n9. Eastern Cooperative Oncology Group performance status ≤ 2 (Appendix 1)\n10. Must have adequate organ and marrow status:\n\n    1. Absolute neutrophil count (ANC) ≥1,000\u002Fmm3 or ≥500\u002Fmm3 if due to disease involvement in the bone marrow\n    2. Platelet count ≥50,000 cells\u002Fmm3 or ≥25,000\u002Fmm3 if due to disease involvement in the bone marrow\n    3. Patients who do not meet criteria for bone marrow function due to marrow involvement of lymphoma and\u002For other disease-related cytopenias (e.g., immune thrombocytopenia) may be enrolled into the study after discussion with, and confirmation by the PI.\n    4. Serum creatinine ≤ULN OR estimated Creatinine Clearance (CrCl) ≥30 mL\u002Fmin (Cockcroft-Gault formula or other institutional standard methods)\n    5. Serum aspartate transaminase (AST) or alanine transaminase (ALT) ≤3 x upper limit of normal (ULN)\n    6. Total bilirubin ≤ 1.5 x ULN (≤3 if due to Gilbert's syndrome or liver involvement by the lymphoma\n    7. Patients who do not meet criteria for liver function due to liver involvement of lymphoma may be enrolled into the study after discussion with, and confirmation by the PI.\n11. Negative HIV test at screening, with the following exception: Individuals with a positive HIV test at screening are eligible provided, prior to enrollment, they are stable on antiretroviral therapy, have a CD4 count ≥200\u002FµL, and have an undetectable viral load.\n12. Signed Informed Consent Form(s)\n13. Ability to comply with all the study-related procedures, in the investigator's judgement\n14. Female patients who are not of child bearing potential (i.e., who are postmenopausal or surgically sterile). For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods, and agree to refrain from donating sperm, as defined below: With a female partner of childbearing potential or pregnant female partners, male participants must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \\\u003C 1% per year during the treatment period and for at least 6 months after pretreatment with obinutuzumab, 6 months after the last dose of polatuzumab, 160 days after the last dose of rituximab, 2 months after the final dose of glofitamab or 2 months after the last dose of tocilizumab (as applicable), whichever is longer. Male participants must refrain from donating sperm during this same period. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the individual. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception. If required per local guidelines or regulations, locally recognized adequate methods of contraception and information about the reliability of abstinence will be described in the local Informed Consent Form.\n\nExclusion Criteria:\n\n1. Prior systemic anti-lymphoma therapy (localized radiation, steroids and antibiotics are permitted)\n2. Prior solid organ transplantation\n3. Prior allogeneic stem cell transplantation\n4. Active CNS involvement\n5. Uncontrolled HIV or active HBV or HCV infection (controlled HIV with undetectable viral load and previously treated HBV and HCV are allowed) 5.1 Participants with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative HBsAg) may be included if hepatitis B virus (HBV) DNA is undetectable at the time of screening. Such participants must be willing to undergo HBV DNA testing on Day 1 of every cycle and every 3 months for at least 12 months after the final cycle of study treatment and appropriate antiviral therapy as indicated.\n\n   5.2 Participants positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA\n6. Uncontrolled active systemic infection\n7. Major surgery within 4 weeks of the first dose of study drug (exceptions may be allowed after discussion with PI if patient has fully recovered from procedure and antilymphoma therapy is urgently needed)\n8. Significant or extensive history of cardiovascular disease such as New York Heart Association Class III or IV cardiac disease or Objective Assessment Class C or D, myocardial infarction within the last 3 months prior to the start of Cycle 1, unstable arrhythmias, or unstable angina.\n9. Uncontrolled autoimmune disorder\n10. A history of confirmed progressive multifocal leukoencephalopathy\n11. Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the subject's safety or risk study outcomes\n12. Inability to comply with all the study-related procedures, in the investigator's judgement.\n13. Contraindication to any of the individual components of polatuzumab, R-miniCHP and glofitamab or history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products\n14. Prior treatment with systemic immunotherapeutic agents, including but not limited to, radio-immuno-conjugates, antibody-drug conjugates, immune\u002Fcytokines and monoclonal antibodies (mAbs) (e.g., anti-cytotoxic T lymphocyte associated protein 4, anti-PD-1, and anti-PD-L1) within 4 weeks or five half-lives of the drug, whichever is shorter 15. Prior use of any monoclonal antibody for the purposes of treating cancer within 3 months of the start of Cycle 1\n15. Prior use of any monoclonal antibody for the purposes of treating cancer within 3 months of the start of Cycle 1\n16. Any investigational therapy for the purposes of treating cancer within 28 days prior to the start of Cycle 1\n17. Prior radiotherapy to the mediastinal\u002Fpericardial region. Radiotherapy to non-target lesion sites will be permitted.\n18. Corticosteroid use \\> 50 mg\u002Fday of prednisone or equivalent, for purposes other than lymphoma symptom control 18.1 Participants receiving corticosteroid treatment with ≤ 50 mg\u002Fday of prednisone or equivalent for reasons other than lymphoma symptom control (e.g., rheumatoid arthritis) must be documented to be on a stable dose of at least 4 weeks duration prior to the start of cycle 18.2 Corticosteroid therapy for control of cancer symptoms or side effects of prior treatment (e.g., nausea or B-symptoms) is permitted.\n\n    18.3 The use of inhaled corticosteroids is permitted. 18.4 The use of mineralocorticoids for management of orthostatic hypotension is permitted.\n\n    18.5 The use of physiologic doses of corticosteroids for management of adrenal insufficiency is permitted.\n19. Participants who require lymphoma symptom control during screening may receive steroids in the following manner: - Up to 100 mg of prednisone PO (or equivalent steroids) per day for up to 7 days are allowed. Prednisone dose is at the discretion of the treating physician, provided that the dose is within the above specified dosage range. - As part of the pre-phase treatment, vincristine or rituximab may not be administered.\n20. History of other malignancy that could affect compliance with the protocol or interpretation of results:\n\n    20.1 Participants with a history of curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix at any time prior to the study are eligible.\n\n    20.2 Participants with any malignancy appropriately treated with curative intent and the malignancy has been in remission without treatment for ≥ 2 years prior to enrollment are eligible.\n\n    20.3 Participants with low-grade, early-stage prostate cancer (Gleason score 6 or below, Stage 1 or 2) with no requirement for therapy at any time prior to study are eligible.\n\n    20.4 Patients with other concomitant malignancies may be eligible after discussion with, and confirmation by the PI\n21. Live, attenuated vaccine within 4 weeks before study treatment infusion on Day 1 of Cycle 1 or anticipation that such a live, attenuated vaccine will be required during the study. Live vaccines during the study and until participants B cells recover, are prohibited.\n\n21.1 Influenza vaccination should be given during influenza season only. Participants must not receive live, attenuated influenza vaccine at any time during the study treatment period.","65 Years",{"count":400,"type":22},42,[58],"The researchers are doing this study to find out if the study treatment is an effective treatment that causes few or mild side effects in people with diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBCL), or transformed lymphoma. The treatment being tested in this study is glofitamab, polatuzumab, and obinutuzumab in combination with standard treatment (the combination of rituximab, cyclophosphamide, doxorubicin, and prednisone, or R-miniCHP).",[97,93],[405,406,407,408,409,410],"Glofitamab","Polatuzumab","Obinutuzumab","Rituximab","Cyclophosphamide","Doxorubicin",{"date":358,"type":39},{"date":413,"type":39},"2025-01-16",{"date":415,"type":22},"2028-01",{"name":417,"class":77},"Memorial Sloan Kettering Cancer Center",8,{"id":420,"slug":421,"hasResults":12,"nctId":422,"briefTitle":423,"officialTitle":424,"acronym":4,"eligibilityCriteria":425,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":426,"targetDuration":4,"studyType":23,"phases":428,"briefSummary":429,"conditions":430,"keywords":435,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":437,"lastUpdatePostDateStruct":438,"startDateStruct":440,"completionDateStruct":441,"leadSponsor":443,"locationsCount":4},"100647760","phase-2-a-phase-ii-study-to-evaluate-the-efficacy-of-uf-kure19-cells-in-patients-with-relapsed-or-refractory-b-cell-non-hodgkin-lymphomas-100647760","NCT07713459","A Phase II Study to Evaluate the Efficacy of UF-KURE19 Cells in Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphomas","A Phase II Single Arm, Open Label Study to Evaluate the Efficacy of UF-KURE19 Cells in Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphomas","Inclusion Criteria:\n\n1. Male or female patients aged 18 years or older.\n2. Participants must have histologically confirmed, CD19 positive (by IHC or flow cytometry) NHL at the most recent biopsy. If a previous CD19 targeting therapy was utilized, a biopsy should be available after this therapy demonstrating sustained CD19 expression.\n3. Subjects in cohort 1 (LBCL) must meet the following inclusion criteria:\n\n   a. Subjects must fit one of the following diagnoses: i. Diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma) ii. High-grade B-cell lymphoma iii. Primary mediastinal large B-cell lymphoma iv. Follicular lymphoma grade 3B b. LBCL disease status must consist of one of the following: i. Relapsed after 2 or more lines of chemoimmunotherapy OR ii. Disease that is refractory to first line chemoimmunotherapy or relapses within 12 months of completion of initial chemoimmunotherapy OR iii. Relapsed disease that is ineligible to receive hematopoietic stem cell transplantation due to comorbidities or age or patient preference\n4. Subjects in cohort 2 (FL) must meet the following inclusion criteria:\n\n   a. Subjects must fit one of the following diagnoses: i. Follicular lymphoma ii. Marginal zone lymphoma b. Disease status must have relapsed after 2 or more lines of therapy\n5. ECOG Performance status ≤ 2.\n6. Participants must exhibit measurable disease with at least one FDG avid lesion at enrollment per Lugano Criteria\n7. Minimum of 2 weeks since prior radiation therapy or systemic therapy to treat malignancy at the time of leukapheresis.\n8. Total bilirubin ≤ 1.5X institutional upper limit of normal.\n9. AST (SGOT)\u002FALT (SGPT) ≤ 2.5 X institutional upper limit of normal.\n10. Calculated creatinine clearance ≥ 30mL\u002Fmin estimated by the Cockcroft - Gault formula.\n11. Cardiac ejection fraction of ≥ 45%.\n12. Adequate pulmonary function, defined as ≤ Grade 1 dyspnea (unless considered secondary to lymphoma) and oxygen saturation (SaO2) ≥ 90% on room air.\n13. Subjects (or legal guardians) must have the ability to understand and the willingness to sign a written informed consent document.\n14. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of \\\u003C 1% per year during the treatment period and for at least 90 days after the UF-KURE19 CAR-T cell infusion.\n\n    A woman is considered to be of childbearing potential if she is post menarcheal, has not reached a postmenopausal state (\\\u003C 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and\u002For uterus). Examples of contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.\n15. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below:\n\n    With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \\\u003C 1% per year during the treatment period and for at least 6 months after the UF-KURE19 CAR-T cell infusion. Men must refrain from donating sperm during this same period. With pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 6 months after the UF-KURE19 CAR-T cell infusion to avoid potential embryonal or fetal exposure. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.\n16. Inclusion of Women and Minorities: Men, women and members of all races and ethnic groups are eligible for this trial.\n\nExclusion Criteria:\n\n* Inclusion Criteria\n\n  1. Male or female patients aged 18 years or older.\n  2. Participants must have histologically confirmed, CD19 positive (by IHC or flow cytometry) NHL at the most recent biopsy. If a previous CD19 targeting therapy was utilized, a biopsy should be available after this therapy demonstrating sustained CD19 expression.\n  3. Subjects in cohort 1 (LBCL) must meet the following inclusion criteria:\n\n     a. Subjects must fit one of the following diagnoses: i. Diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma) ii. High-grade B-cell lymphoma iii. Primary mediastinal large B-cell lymphoma iv. Follicular lymphoma grade 3B b. LBCL disease status must consist of one of the following: i. Relapsed after 2 or more lines of chemoimmunotherapy OR ii. Disease that is refractory to first line chemoimmunotherapy or relapses within 12 months of completion of initial chemoimmunotherapy OR iii. Relapsed disease that is ineligible to receive hematopoietic stem cell transplantation due to comorbidities or age or patient preference\n  4. Subjects in cohort 2 (FL) must meet the following inclusion criteria:\n\n     a. Subjects must fit one of the following diagnoses: i. Follicular lymphoma ii. Marginal zone lymphoma b. Disease status must have relapsed after 2 or more lines of therapy\n  5. ECOG Performance status ≤ 2.\n  6. Participants must exhibit measurable disease with at least one FDG avid lesion at enrollment per Lugano Criteria\n  7. Minimum of 2 weeks since prior radiation therapy or systemic therapy to treat malignancy at the time of leukapheresis.\n  8. Total bilirubin ≤ 1.5X institutional upper limit of normal.\n  9. AST (SGOT)\u002FALT (SGPT) ≤ 2.5 X institutional upper limit of normal.\n  10. Calculated creatinine clearance ≥ 30mL\u002Fmin estimated by the Cockcroft - Gault formula.\n  11. Cardiac ejection fraction of ≥ 45%.\n  12. Adequate pulmonary function, defined as ≤ Grade 1 dyspnea (unless considered secondary to lymphoma) and oxygen saturation (SaO2) ≥ 90% on room air.\n  13. Subjects (or legal guardians) must have the ability to understand and the willingness to sign a written informed consent document.\n  14. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a contraceptive method with a failure rate of \\\u003C 1% per year during the treatment period and for at least 90 days after the UF-KURE19 CAR-T cell infusion.\n\n      A woman is considered to be of childbearing potential if she is post menarcheal, has not reached a postmenopausal state (\\\u003C 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and\u002For uterus). Examples of contraceptive methods with a failure rate of \\\u003C 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.\n  15. For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm, as defined below:\n\n      With female partners of childbearing potential, men must remain abstinent or use a condom plus an additional contraceptive method that together result in a failure rate of \\\u003C 1% per year during the treatment period and for at least 6 months after the UF-KURE19 CAR-T cell infusion. Men must refrain from donating sperm during this same period. With pregnant female partners, men must remain abstinent or use a condom during the treatment period and for at least 6 months after the UF-KURE19 CAR-T cell infusion to avoid potential embryonal or fetal exposure. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.\n  16. Inclusion of Women and Minorities: Men, women and members of all races and ethnic groups are eligible for this trial.\n\nExclusion Criteria\n\n1. Autologous stem cell transplant within 12 weeks of informed consent.\n2. History of allogeneic hematopoietic stem cell transplantation.\n3. Second active malignancy that is not another NHL, other than non-melanoma skin cancer, carcinoma in situ (e.g. cervix, bladder, breast), stage 1 uterine cancer, or localized prostate cancer.\n4. Less than 28 days or 5 half-lives elapsed whichever is shorter between prior treatment with investigational agent(s) and leukapheresis.\n5. New York Heart Association class III-IV congestive heart failure.\n6. Cardiovascular disorders including unstable angina pectoris, clinically significant and uncontrolled cardiac arrhythmias, myocardial infarction or stroke (including transient ischemic attack, or other ischemic event) within 6 months prior to registration.\n7. Confirmed active human immunodeficiency virus (HIV) infection.\n8. Pregnant or breastfeeding women are excluded from this study because CAR-T cell therapy may be associated with the potential for teratogenic or abortifacient effects. Women of childbearing potential must have a negative serum pregnancy test. Because there is an unknown, but potential risk for adverse events in nursing infants secondary to treatment of the mother with CAR-T cells, breastfeeding should be discontinued. These potential risks may also apply to other agents used in this study.\n9. Evidence of myelodysplasia or cytogenetic abnormality indicative of myelodysplasia on any bone marrow biopsy prior to initiation of therapy.\n10. Serologic status reflecting active hepatitis B or C infection. Patients that are positive for hepatitis B core antibody, hepatitis B surface antigen (HBsAg), or hepatitis C antibody must have a negative polymerase chain reaction (PCR) prior to enrollment. (PCR positive patients will be excluded).\n11. Patients with history of clinically relevant CNS pathology such as epilepsy, seizure disorders, paresis, aphasia, uncontrolled cerebrovascular disease, severe brain injuries, dementia and Parkinson's disease.\n12. Subjects with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, pulmonary abnormalities or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n13. History of active autoimmune disease (i.e. rheumatoid arthritis, systemic lupus erythematosus) with requirement of systemic immunosuppressive medications other than low dose steroids \\[i.e. maximum of 15mg prednisone equivalent\\] within the last 6 months.\n14. History of leukemic phase lymphoma or presence of 1% or more circulating lymphoma cells at subject enrollment.\n15. Previous treatment with a CD19 CAR-T product",{"count":427,"type":22},105,[58],"The goal of this Phase II single-arm, open-label clinical trial is to evaluate whether UF-KURE19, an autologous CD19-directed CAR-T cell therapy manufactured t…The goal of this Phase II single-arm, open-label clinical trial is to evaluate whether UF-KURE19, an autologous CD19-directed CAR-T cell therapy manufactured through an ultra-fast (less than 1 day) process, can treat adult patients (18 years and older, male or female) with relapsed or refractory B-cell Non-Hodgkin Lymphoma (NHL), including Large B-Cell Lymphoma (LBCL), Follicular Lymphoma (FL), and Marginal Zone Lymphoma (MZL).\n\nThe participants will be divided in two cohorts:\n\n81 participants in Cohort 1: Large B-Cell Lymphoma (LBCL) 24 participants in Cohort 2: Follicular Lymphoma (FC) and Marginal Zone Lymphoma (MZL)\n\nThe main questions it aims to answer are:\n\n1. Can UF-KURE19 achieve a clinically meaningful complete response rate (CRR) of ≥ 45% in patients with relapsed\u002Frefractory LBCL at Day 90 post-infusion, per Lugano Revised Response Criteria?\n2. Can UF-KURE19 achieve a CRR of ≥ 60% in patients with relapsed\u002Frefractory Follicular or Marginal Zone Lymphoma at Day 90 post-infusion?\n\nThere is no comparison group. This is a single-arm study, (all participants receive UF-KURE19) with 2 cohorts as outlined above.\n\nParticipants will:\n\n1. Undergo leukapheresis for collection of their own T cells, which will be used to manufacture UF-KURE19.\n2. Subsequently they will receive a single intravenous infusion of UF-KURE19 (10×10⁶ cells for patients ≥50kg; 7×10⁶ cells for patients \\\u003C50kg) Complete disease response assessments at Day 90 post-infusion per Lugano criteria\n3. Undergo safety monitoring including adverse event collection, laboratory tests, neurological exams, CAR-T persistence assays, and replication-competent lentivirus (RCL) testing throughout the study\n4. Be followed long-term for up to 15 years post-infusion for gene therapy safety surveillance per FDA requirements",[431,432,97,433,434],"Lymphoma Nonhodgkin","Marginal Zone B Cell Lymphoma","Follicular B-cell Non-Hodgkin's Lymphoma","CAR T Cell Therapy",[436,232],"CAR T-cell","2026-07-17",{"date":439,"type":39},"2026-07-20",{"date":323,"type":22},{"date":442,"type":22},"2029-11-30",{"name":444,"class":46},"Kure Cells, INC",{"id":446,"slug":447,"hasResults":12,"nctId":448,"briefTitle":449,"officialTitle":450,"acronym":4,"eligibilityCriteria":451,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":452,"targetDuration":4,"studyType":23,"phases":454,"briefSummary":455,"conditions":456,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":458,"startDateStruct":460,"completionDateStruct":461,"leadSponsor":463,"locationsCount":278},"100638003","phase-2-a-study-of-glofitamab-plus-gemox-compared-with-standard-of-care-in-patients-with-relapsedrefractory-diffuse-large-b-cell-lymphoma-100638003","NCT07599423","A Study of Glofitamab Plus GemOx Compared With Standard of Care in Patients With Relapsed\u002FRefractory Diffuse Large B-Cell Lymphoma","An Open-Label, Multicenter, Randomized Study Evaluating the Efficacy and Safety of Glofitamab in Combination With Gemcitabine Plus Oxaliplatin Versus Standard of Care in Patients With Relapsed\u002FRefractory Diffuse Large B-Cell Lymphoma","Inclusion Criteria:\n\n* Signed Informed Consent Form.\n* Age 18 years or older at the time of signing the Informed Consent Form.\n* Histologically proven diffuse large B-cell lymphoma (DLBCL), including transformation from follicular lymphoma.\n* Relapsed or refractory disease after first-line chemoimmunotherapy, defined as refractory disease (no complete remission to first-line therapy, progressive disease as best response, stable disease after 3-4 cycles, or partial response after 6-8 cycles\u002Fprogression within 12 months of first-line therapy) or relapsed disease (complete remission followed by biopsy-proven relapse within 12 months of first-line therapy).\n* No known history or suspicion of central nervous system (CNS) involvement by lymphoma.\n* Life expectancy of at least 12 weeks.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.\n* At least one bi-dimensionally measurable nodal lesion (1.5 cm or larger) or extranodal lesion (1 cm or larger) as measured on a CT scan.\n* Negative HIV test at screening.\n* Adequate hematologic function defined as hemoglobin 9.0 g\u002FdL or higher without transfusion in the past 7 days, absolute neutrophil count 1.0 x 10\\^9\u002FL or higher, and platelet count 75 x 10\\^9\u002FL or higher.\n* Adequate organ function defined as estimated creatinine clearance 60 mL\u002Fmin or higher, ALT\u002FAST 2.5 times the upper limit of normal (ULN) or lower, and total bilirubin 1.5 mg\u002FdL or lower (or 3 x ULN or lower in subjects with Gilbert's syndrome).\n* Cardiac ejection fraction greater than 50%, no evidence of pericardial effusion, and no clinically significant electrocardiogram findings.\n* No clinically significant pleural effusion.\n* Baseline oxygen saturation greater than 92% on room air.\n* Able to understand and complete study-related questionnaires.\n* Agreement to remain abstinent or use adequate contraceptive methods for both female and male participants during the treatment period and for the protocol-specified duration after the final dose.\n\nExclusion Criteria:\n\n* Contraindication to glofitamab components or a history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies.\n* Not eligible for autologous stem cell transplantation (ASCT).\n* Prior solid organ transplantation.\n* History of Richter's transformation or of indolent disease to diffuse large B-cell lymphoma (DLBCL) or primary mediastinal B-cell lymphoma (PMBCL).\n* Peripheral neuropathy assessed to be greater than Grade 1 at enrollment.\n* Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3.\n* Use of any investigational therapy for treating cancer within 28 days prior to Cycle 1, any monoclonal antibody within 3 months, or systemic immunotherapeutic agents within 4 weeks or five half-lives (whichever is shorter).\n* Prior radiotherapy to the mediastinal or pericardial region.\n* History of autologous or allogeneic stem cell transplant.\n* Adverse events from prior anti-cancer therapy that have not resolved to Grade 1 or better, except for alopecia and anorexia.\n* Administration of a live, attenuated vaccine within 4 weeks before the first study treatment administration.\n* Received more than one line of therapy for DLBCL.\n* Corticosteroid use greater than 50 mg\u002Fday of prednisone or equivalent for purposes other than lymphoma symptom control.\n* Recent major surgery within 4 weeks before the first study treatment.\n* History of other malignancy that could affect compliance or interpretation of results, with exceptions for adequately treated low-grade or in situ carcinomas and malignancies in remission for at least 2 years.\n* Significant cardiovascular disease, such as New York Heart Association Class III or IV cardiac disease, myocardial infarction within the past 3 months, unstable arrhythmias, or unstable angina.\n* Current or past history of central nervous system (CNS) disease, such as stroke, epilepsy, CNS vasculitis, neurodegenerative disease, or CNS lymphoma.\n* Known or suspected history of hemophagocytic lymphohistiocytosis (HLH).\n* Current or past history of Waldenstrom macroglobulinemia.\n* History or presence of a clinically significant abnormal ECG.\n* Known or suspected active infection, reactivation of a latent infection, or any major episode of infection requiring hospitalization or IV antibiotics within 4 weeks of dosing.\n* History of severe treatment-emergent immune-related adverse events associated with prior immunotherapeutic agents.\n* History of autoimmune disease, with specific protocol-defined exceptions for well-controlled conditions.\n* Clinically significant liver disease, including active viral\u002Fother hepatitis or cirrhosis.\n* Abnormal coagulation laboratory values defined as INR or PT greater than 1.5 x ULN, or PTT\u002FaPTT greater than 1.5 x ULN.\n* Suspected active or latent tuberculosis.\n* Positive test results for chronic hepatitis B infection (HBsAg positive) or positive test results for hepatitis C with positive HCV RNA.\n* Diagnosis with SARS-CoV-2 infection within 30 days prior to first study treatment, or documented infection within 6 months with persistent respiratory symptoms.\n* History of progressive multifocal leukoencephalopathy (PML).\n* Pregnancy, breastfeeding, or intention of becoming pregnant during the study.",{"count":453,"type":22},96,[58],"The purpose of this study is to evaluate the efficacy and safety of glofitamab in combination with gemcitabine plus oxaliplatin (GemOx) versus standard of care (SOC) in patients with relapsed\u002Frefractory diffuse large B-cell lymphoma (R\u002FR DLBCL) who have relapsed early (within 1 year) or are primary refractory to first-line therapy. Participants will be randomly assigned in a 1:1 ratio to receive either the Glofitamab-GemOx combination regimen or SOC. The SOC arm consists of investigator's choice of salvage chemoimmunotherapy followed by autologous stem cell transplantation (ASCT) for eligible patients. The primary endpoint of the study is event-free survival (EFS).",[97],"2026-07-10",{"date":459,"type":39},"2026-07-13",{"date":358,"type":22},{"date":462,"type":22},"2030-12-31",{"name":464,"class":77},"The First Affiliated Hospital of Soochow University",{"id":466,"slug":467,"hasResults":12,"nctId":468,"briefTitle":469,"officialTitle":470,"acronym":471,"eligibilityCriteria":472,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":473,"targetDuration":475,"studyType":476,"phases":4,"briefSummary":477,"conditions":478,"keywords":481,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":457,"lastUpdatePostDateStruct":483,"startDateStruct":484,"completionDateStruct":486,"leadSponsor":488,"locationsCount":278},"100519397","registry-platform-hematologic-malignancies-rubin---extension-of-tumor-registry-lymphatic-neoplasms-100519397","NCT06043011","Registry Platform Hematologic Malignancies (RUBIN) - Extension of Tumor Registry Lymphatic Neoplasms","Clinical Research Platform on Treatment, Quality of Life and Outcome of Patients With Hematologic Malignancies (RUBIN) - Extension of Tumor Registry Lymphatic Neoplasms","RUBIN","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Confirmed diagnosis of the respective NHL\n* If patient is alive: signed written informed consent\n\n  * For patients participating in the PRO survey: IC prior to or at day of start of respective line of treatment.\n  * For patients not participating in the PRO survey: IC latest eight weeks after start of respective line of treatment.\n\nExclusion Criteria:\n\n* No systemic therapy for respective lymphoid malignancy.",{"count":474,"type":22},2950,"5 Years","OBSERVATIONAL","The purpose of the project is to set up a national, prospective, longitudinal, multicenter registry platform to document uniform data on characteristics, molecular diagnostics, treatment and course of disease, to collect patient-reported outcomes and to establish a decentralized biobank for patients with hematological malignancies in Germany.",[479,28,124,126,125,480],"Chronic Lymphocytic Leukemia (CLL)","Waldenström's Macroglobulinemia (WM)",[482],"non-Hodgkin lymphoma (NHL)",{"date":459,"type":39},{"date":485,"type":39},"2023-09-27",{"date":487,"type":22},"2033-12",{"name":489,"class":46},"iOMEDICO AG",{"id":491,"slug":492,"hasResults":12,"nctId":493,"briefTitle":494,"officialTitle":495,"acronym":4,"eligibilityCriteria":496,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":497,"targetDuration":4,"studyType":23,"phases":499,"briefSummary":500,"conditions":501,"keywords":506,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":516,"lastUpdatePostDateStruct":517,"startDateStruct":519,"completionDateStruct":521,"leadSponsor":522,"locationsCount":524},"100449326","phase-1-a-study-of-nx-5948-in-adults-with-relapsedrefractory-b-cell-malignancies-100449326","NCT05131022","A Study of NX-5948 in Adults With Relapsed\u002FRefractory B-cell Malignancies","A Phase 1, Dose Escalation, and Cohort Expansion Study Evaluating NX-5948, a Bruton's Tyrosine Kinase (BTK) Degrader, in Adults With Relapsed\u002FRefractory B-cell Malignancies","Key Inclusion Criteria:\n\n* Age ≥18 years\n* Patients in Phase 1a (Dose Escalation) must have histologically confirmed R\u002FR CLL, SLL, DLBCL (subgroups include Richter-transformed DLBCL, germinal center B-cell type, activated B-cell type, high-grade B-cell lymphoma with MYC and BCL-2 and\u002For BCL-6 rearrangements, high-grade B-cell lymphomas NOS), FL, MCL, MZL (subtypes include EMZL, MALT, NMZL, SMZL), WM, or PCNSL.\n* Patients in Phase 1a must meet the following:\n\n  o For non-PCNSL indications, received at least 2 prior lines of therapy and have no other available therapies known to provide clinical benefit. For PCNSL, received at least 1 prior line of therapy\n* Patients in Phase 1b (Safety and Cohort Expansion) must have 1 of the following histologically documented B-cell malignancies, must meet criteria for systemic treatment, and must have received prior therapies and\u002For molecular features based on details described for each cohort: CLL or SLL, DLBCL, MCL, FL, MZL, WM, or PCNSL\u002FSCNSL.\n* Measurable disease per response criteria specific to the malignancy.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (0-2 for patients with PCNSL and secondary CNS involvement).\n* Adequate organ and bone marrow function\n\nKey Exclusion Criteria:\n\n* Known or suspected active prolymphocytic leukemia or Richter's transformation to Hodgkin's lymphoma prior to study enrollment\n* Prior treatment for the indication under study for anti-cancer intent that includes:\n\n  1. Radiotherapy within 2 weeks of planned start of study drug (excluding limited palliative radiation).\n  2. Prior systemic chemotherapy within 2 weeks of planned start of study drug.\n  3. Prior monoclonal antibody therapy within 4 weeks of planned start of study drug, except for patients enrolling in Cohort 16 (CLL with secondary wAIHA) where a 16-week washout period is required.\n  4. Prior small molecule therapy within 2 weeks or 5 half-lives (whichever is shorter) of planned start of study drug.\n  5. Autologous or allogeneic stem cell transplant within 100 days prior to planned start of study drug.\n  6. Chimeric antigen receptor (CAR) T-cell therapy within 100 days prior to start of study drug (within 60 days prior to start of study drug for Phase 1b).\n  7. Use of systemic corticosteroids outside of dosing limits described below and within 7 days prior to initiation of study treatment excepting those used as prophylaxis for radio diagnostic contrast. Patients with PCNSL\u002FSCNSL: no greater than 40 mg\u002Fday prednisone, or equivalent. Patients with PCNSL\u002FSCNSL using greater than 20 mg\u002Fday prednisone, or equivalent, must be clinically stable at that dose for 7 days. All other diagnoses: no greater than 20 mg\u002Fday prednisone or equivalent.\n  8. Use of systemic immunosuppressive drugs other than systemic corticosteroids for any medical condition within 60 days prior to first dose of study drug\n  9. Previously treated with a BTK degrader\n* Active, uncontrolled autoimmune hemolytic anemia (except for patients enrolling in Cohort 16) or active, uncontrolled autoimmune thrombocytopenia.\n* Patient has any of the following within 6 months of planned start of study drug:\n\n  1. Myocardial infarction, unstable angina, unstable symptomatic ischemic heart disease, or placement of a coronary arterial stent\n  2. Uncontrolled atrial fibrillation or other clinically significant arrhythmias, conduction abnormalities, or New York Heart Association (NYHA) class III or IV heart failure\n  3. Thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), stroke, or intracranial hemorrhage\n  4. Any other significant cardiac condition (e.g., pericardial effusion, restrictive cardiomyopathy, severe untreated valvular stenosis, severe congenital heart disease, or persistent uncontrolled hypertension defined as systolic blood pressure \\> 160 mmHg or diastolic blood pressure \\> 100 mmHg despite optimal medical management)\n* Bleeding diathesis, or other known risk for acute blood loss.\n* History of Grade ≥ 2 hemorrhage within 28 days of planned start of study drug.\n* Active known concurrent malignancy or malignancy other than the one under study within the past 3 years. (Exceptions include, but are not limited to, patients with more recent history of basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast may enroll if they have undergone curative therapy and have no evidence of disease).",{"count":498,"type":22},572,[89],"This is a first-in-human Phase 1a\u002F1b multicenter, open-label study designed to evaluate the safety and anti-cancer activity of NX-5948 in patients with advanced B-cell malignancies.",[479,502,97,124,126,125,503,504,505],"Small Lymphocytic Lymphoma (SLL)","Waldenstrom Macroglobulinemia (WM)","Primary Central Nervous System Lymphoma (PCNSL)","Secondary Central Nervous System Lymphoma (SCNSL)",[507,508,509,237,510,511,512,513,514,515],"BTK Degrader","BTK Inhibitor","B-Cell Malignancy","C481","C481S","Bruton's Tyrosine Kinase","NX-5948","Targeted Protein Degradation","Chimeric Targeting Molecule (CTM)","2026-06-30",{"date":518,"type":39},"2026-07-02",{"date":520,"type":39},"2022-04-13",{"date":415,"type":22},{"name":523,"class":46},"Nurix Therapeutics, Inc.",62,{"id":526,"slug":527,"hasResults":12,"nctId":528,"briefTitle":529,"officialTitle":530,"acronym":4,"eligibilityCriteria":531,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":532,"targetDuration":4,"studyType":23,"phases":534,"briefSummary":535,"conditions":536,"keywords":539,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":545,"lastUpdatePostDateStruct":546,"startDateStruct":548,"completionDateStruct":550,"leadSponsor":552,"locationsCount":278},"100629759","phase-1-radiation-oral-vancomycin-and-car-t-for-b-cell-lymphomas-100629759","NCT07478848","Radiation, Oral Vancomycin, and CAR-T for B-Cell Lymphomas","A Pilot Trial of Bridging Radiation Therapy With Oral Vancomycin for Patients With B-cell Lymphomas Undergoing CAR-T Therapy","Inclusion Criteria:\n\n* Male or female subject aged ≥ 18 years.\n* Pathologically confirmed B-cell lymphoma patients intended for standard of care CAR-T\n* ECOG Performance Status ≤ 2.\n* Subjects must be clinically eligible to receive standard of care anti-CD19 CAR-T\n* Subjects must have at least one site of disease amenable to radiation, with the ability to deliver radiation to at least 50% of involved sites\n* Subjects must have at least one site of measurable disease based on CT or FDG PET\n* Subjects must not be anticipated to require additional therapy beyond bridging radiation listed in this protocol for control of their lymphoma\n* For female subjects: Negative pregnancy test or evidence of post-menopausal status. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause.\n\nThe following age-specific requirements apply:\n\nWomen \\\u003C 50 years of age: amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution; or Underwent surgical sterilization (bilateral oophorectomy or hysterectomy).\n\nWomen ≥ 50 years of age: amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or had radiation-induced menopause with last menses \\>1 year ago; or had chemotherapy-induced menopause with last menses \\>1 year ago; or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).\n\n* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n\nExclusion Criteria:\n\n* Unable to take oral vancomycin for any reason, including: Allergy or Inability to swallow drug\n* Known history of vancomycin resistant enterococcus (VRE)\n* Contraindications to radiation therapy, including scleroderma, systemic lupus erythematosus, Crohn disease, ulcerative colitis, or idiopathic pulmonary fibrosis\n* History of radiation pneumonitis or other grade 4 radiation-related adverse event\n* Prior or concurrent malignancy whose natural history or treatment which has the potential to interfere with the safety or efficacy assessment of the radiation therapy are eligible for this trial.\n* Severe, uncontrolled, significant intercurrent or recent illness that would exclude them from being a candidate for standard-of-care CART therapy.\n* Known uncontrolled HIV infection with a detectable viral load at the time of screening. Note: Patients on effective antiretroviral therapy or who will plan on going on antiretroviral therapy at the time of screening are eligible for this trial. HIV testing is not required for eligibility.\n* Active infection that required the use of antibiotics within 4 weeks prior to registration\n* Any other condition that would, in the investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures",{"count":533,"type":22},14,[89],"This clinical trial assesses whether it is feasible to use radiation therapy with vancomycin prior to CAR T-cell therapy for patients with large B-cell lymphomas",[537,538,97,234,235],"Large B Cell Lymphoma","Non Hodgkin Lymphoma (NHL)",[540,541,542,543,544],"non-hodgkin lymphoma","NHL","large B cell lymphoma","DLBCL","diffuse large B cell lymphoma","2026-06-29",{"date":547,"type":39},"2026-07-01",{"date":549,"type":39},"2026-05-29",{"date":551,"type":22},"2029-01-01",{"name":553,"class":77},"Abramson Cancer Center at Penn Medicine",{"id":555,"slug":556,"hasResults":12,"nctId":557,"briefTitle":558,"officialTitle":559,"acronym":4,"eligibilityCriteria":560,"healthyVolunteers":12,"sex":18,"minAge":561,"maxAge":4,"enrollmentInfo":562,"targetDuration":4,"studyType":23,"phases":564,"briefSummary":565,"conditions":566,"keywords":573,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":545,"lastUpdatePostDateStruct":581,"startDateStruct":582,"completionDateStruct":584,"leadSponsor":586,"locationsCount":78},"100426707","phase-1-study-of-efficacy-and-safety-of-crc01-in-adult-large-b-cell-lymphoma-and-b-cell-acute-lymphoblastic-leukemia-patients-100426707","NCT04836507","Study of Efficacy and Safety of CRC01 in Adult Large B-cell Lymphoma and B-cell Acute Lymphoblastic Leukemia Patients","An Open-label, Multi-center, Single-arm Phase 1\u002F2 Study to Assess Tolerability, Safety and Efficacy of CRC01 in Adult Patients With Relapsed or Refractory Large B-cell Lymphoma and B-cell Acute Lymphoblastic Leukemia","Cohort A:\n\nInclusion Criteria:\n\n1. ≥ 19 years of age and provided written informed consent\n2. Histologically confirmed following large B-cell lymphomas according to the World Health Organization classification 2017\n\n   * Diffuse large B-cell lymphoma, not otherwise specified Including Large cell transformation from follicular lymphoma (Transformed follicular lymphoma)\n   * High-grade B-cell lymphoma, not otherwise specified\n   * High-grade B-cell lymphoma with double-hit\u002Ftriple-hit\n   * Primary mediastinal large B cell lymphoma\n3. Relapsed or refractory disease after ≥ two lines of chemotherapy including rituximab, anthracycline and either having failed autologous Hematopoietic stem cell transplantation (ASCT) or being ineligible for or not consenting to ASCT.\n4. At least one measurable lesion (Long diameter ≥ 1.5cm)\n5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n6. Adequate renal and hepatic functions based on the laboratory test results\n\n   * Total Bilirubin ≤ 2.0mg\u002FdL with the exception of patients with Gilbert-Meulengracht syndrome; patients with Gilbert-Meulengracht syndrome may be included if their total bilirubin is ≤ 3 X ULN and direct bilirubin ≤ 1.5 X ULN.\n   * Aspartate transaminase (AST) and Alanine transaminase (ALT) ≤ 3 X Upper Limit of Normal (ULN) for age with exception of liver metastasis; patients with liver metastasis may be included if their AST and ALT are ≤ 5 X ULN.\n   * Serum creatinine ≤ 1.5 X ULN\n   * Estimated Glomerular Filtration Rate (eGFR) ≥ 60mL\u002Fmin\u002F1.73m2\n7. Adequate hematologic function without transfusions within 2 weeks prior to screening for the study defined as followings:\n\n   * Hemoglobin \\> 8.0g\u002F㎗\n   * Absolute Neutrophil Count (ANC) \\> 1,000\u002F㎕\n   * Absolute Lymphocyte Count (ALC) ≥ 300\u002F㎕\n   * Platelets ≥ 50,000\u002F㎕\n8. Must have a minimum level of pulmonary reserve defined as;\n\n   * ≤ Grade 1 dyspnea per Common terminology criteria for adverse events (CTCAE) v5.0\n   * pulse oxygenation \\> 91% on room air\n9. Hemodynamically stable, without pericardial effusion and Left Ventricle Ejection Fraction (LVEF) ≥ 50% confirmed by Echocardiogram (ECG) or Multigated Radionuclide Angiography (MUGA)\n10. Must have an apheresis product of non-mobilized cells accepted for manufacturing\n11. Life expectancy ≥ 12 weeks\n12. Women of child-bearing potential and all male participants must agree to use highly effective methods of contraception for at least 12 months following CRC01 infusion and until CRC01 are no longer present by PCR on two consecutive tests\n\nExclusion Criteria:\n\n1. Patients with the following medical history\n\n   * Previous or concurrent malignancy with the following exceptions:\n\n     * Adequately treated basal cell or squamous cell carcinoma without evidence of recurrence for at least 3 years prior to the study\n     * In situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 3 years prior to the study\n     * A primary malignancy which has been completely resected and in complete remission for ≥ 5 years\n   * Unstable angina and\u002For myocardial infarction within 12 months prior to screening\n   * Thromboembolic events, pulmonary embolism or bleeding diatheses within 6 months prior to screening\n   * Hypoxemia, significant pleural effusion or significant EKG findings within 6 months prior to the screening\n2. Patients with the following concurrent disease at screening:\n\n   * Central Nervous System (CNS) involvement by malignancy by MRI at screening\n   * Active infection with hepatitis B (HBsAg positive. But, in case of HBcAb IgG positive, the patient can be enrolled in this study if he\u002Fshe takes prophylactic anti-viral agent.)\n   * Active infection with hepatitis C (HCV RNA positive)\n   * Human immunodeficiency virus (HIV) positive\n   * Active neurological auto-immune or inflammatory disorder (e.g. Guillain Barre Syndrome, Amyotrophic Lateral Sclerosis)\n   * Ventricular tachycardia and atrial fibrillation with rapid ventricular response not controlled with medical treatment within 3 months prior to screening\n3. Rapidly progressing the disease as per investigator's discretion\n4. Had major surgery requiring general anesthesia or mechanical ventilation within 4 weeks prior to screening (For video-assisted thoracoscopic surgery (VATS) or open-and-closed (ONC) surgery can be applied with within 2 weeks prior to screening.)\n5. Severe infection requiring anti-bacterial, anti-fungal or anti-viral medication or uncontrolled active infection\n6. The following treatment history is excluded:\n\n   * Prior treatment with any prior anti-CD19\u002Fanti-CD3 therapy or any other anti-CD19 therapy\n   * Prior treatment with any adoptive T cell therapy\n   * Treatment with any prior gene therapy product\n   * Prior allogeneic HSCT\n   * Patients on oral anticoagulation therapy\n7. Eligible for and consenting to ASCT\n8. Use of investigational medicinal product\u002Fdevice within 4 weeks prior to screening\n9. Pregnant or lactating women\n10. Hypersensitivity reaction to the excipients of CRC01 cell product\n11. The following treatments are excluded:\n\n    * Anti-neoplastic therapies including chemotherapy, biologic agents, retinoid therapy, radiotherapy, immune therapy, hormonal therapy, etc. other than lymphodepleting chemotherapy within 2 weeks of leukapheresis and within 2 weeks of CRC01 infusion\n    * Steroids: therapeutic doses of steroids must be stopped \\> 7 days prior to leukapheresis and \\> 5 days prior to CRC01 infusion. However, the following physiological replacement doses of steroids are allowed: \\\u003C 6 mg\u002Fm2\u002Fday hydrocortisone or equivalent\n    * Immunosuppression: any immunosuppressive medication must be stopped \\> 4 weeks prior to leukapheresis and \\> 4 weeks prior to CRC01 infusion\n    * Antibody use including anti-CD20 therapy within 4 weeks prior to CRC01 infusion\n    * CNS disease prophylaxis must be stopped \\> 1 week prior to CRC01 infusion (e.g. intrathecal methotrexate)\n\nCohort B :\n\nInclusion Criteria :\n\n1. ≥ 19 years of age and provided written informed consent to voluntarily participate in this trial\n2. Relapsed or refractory B-cell lymphoblastic leukemia with one of the following:\n\n   * Primary refractory: Newly diagnosed and refractory to 2 or more cycles of standard chemotherapy\n   * Relapsed within 12 months of the first complete remission\n   * Chemorefractory: Refractory to 1 cycle of chemotherapy conducted after relapse\n   * Relapsed after or refractory to two or more lines of chemotherapy\n   * Relapsed or refractory 100 days after allogeneic HSCT\n3. (within 4 weeks prior to screening) Blast of \\> 5% identified in the BM\n4. (within 4 weeks prior to screening) BM or peripheral blood blast confirmed CD19-positive.\n\n   Specifically, those with prior treatment with any other anti-CD19 therapy must be confirmed to show CD19 ≥ 90%.\n5. Philadelphia chromosome positive with one of the following:\n\n   * Unable to take tyrosine kinase inhibitors (TKIs) due to side effects\n   * Relapsed or refractory despite treatment with two or more TKIs\n6. ECOG performance status of 0-1\n7. Confirmed adequate hematologic function defined as follows:\n\n   * Absolute neutrophil count (ANC) ≥ 500\u002FμL. However, exceptions are made in cases where the Investigator determines that cytopenia is related to the leukemia and may be recovered with leukemia treatment.\n   * Platelet count ≥ 50,000\u002FμL. However, exceptions are made in cases where the Investigator determines that cytopenia is related to the leukemia and may be recovered with leukemia treatment.\n   * Absolute lymphocyte count ≥ 200\u002FμL\n8. Adequate renal and hepatic functions confirmed based on the laboratory test results:\n\n   * Total Bilirubin ≤ 2.0 mg\u002FdL (for patients with Gilbert-Meulengracht syndrome, total bilirubin ≤ 3 × ULN and direct bilirubin ≤ 1.5 × ULN)\n   * AST and ALT ≤ 3 × ULN\n   * Serum creatinine ≤ 1.5 × ULN or eGFR\\* ≥ 45 mL\u002Fmin\u002F1.73 m2 \\*MDRD-GFR (mL\u002Fmin\u002F1.73 m2) = 186 × (serum creatinine)-1.154 × (age)-0.203 (× 0.742 for females)\n9. Confirmed to have a minimum level of pulmonary reserve according to the following criteria:\n\n   * ≤ Grade 1 dyspnea per CTCAE v5.0\n   * Pulse oxygenation \\> 91% on room air\n10. Hemodynamically stable, without pericardial effusion, and LVEF ≥ 50% confirmed by ECHO or MUGA scan at Screening\n11. Capable of obtaining through leukapheresis non-mobilized cells adequate for CRC01 manufacturing\n12. Life expectancy of ≥ 12 weeks\n13. Consented to comply with the site visit and test schedules for Primary Follow-up and Secondary Follow-up in accordance with the Protocol for the duration of the Study\n14. WOCBP or male subjects who are willing to use appropriate contraceptive methods\\* for at least 12 months following CRC01 treatment and until CRC01 is no longer detected through two consecutive PCR tests \\* Hormonal contraceptives, placement of intrauterine system, double barrier method (simultaneous use of contraceptive vaginal diaphragm or cervical cap and male condom, along with spermicide), sterilization (vasectomy, bilateral tubal ligation), etc.\n\nExclusion Criteria:\n\nPatients in Cohort B may not participate in this trial if any of the following criteria apply.\n\n1. Patients with the following medication or treatment history:\n\n   ① Donor lymphocyte infusion (DLI) within 4 weeks\n   * Graft-versus-host-disease (GVHD) treatment within four weeks (In case of maintaining medication for post-treatment prophylaxis, the decision on the subject's participation in the clinical trial may be made after contacting and consulting with the Sponsor's Medical Monitor.)\n\n     * Central nervous system (CNS) radiotherapy or intracerebrospinal antineoplastic therapy within eight weeks (However, intrathecal therapy for prophylaxis purposes is an exception) ④ Systemic salvage chemotherapy that includes TKI and blinatumomab for treatment of Philadelphia positive ALL within one week prior to Screening or five half-lives of the administered drug (whichever is shorter)\n\n       * Any prior anti-CD19 treatment (with the exception of blinatumomab) ⑥ History of neurological toxicity ≥ Grade 4 or cytokine release syndrome (CRS) ≥ Grade 4 per CTCAE during prior anti-CD19 treatment\n2. Patients with the following CNS abnormality:\n\n   ① CNS-3 disease, defined by WBC ≥ 5\u002FμL in CSF and confirmed presence of lymphoblast, with or without neurological symptoms\n\n   ② CNS-3 disease, defined by WBC \\\u003C 5\u002FμL in CSF and confirmed presence of lymphoblast, with neurological symptoms (cases of CNS-1 disease without evidence of leukemia involvement in CSF and CNS-2 disease without neurological symptoms may be enrolled)\n\n   ③ Current or prior history of CNS disorder, such as epilepsy\u002Fseizure, cerebrovascular ischemia\u002Fbleeding, dementia, cerebellar disorder, autoimmune disease with CNS invasion, posterior reversible encephalopathy syndrome (PRES) or cerebral edema\n3. Burkitt's lymphoma\u002Fleukemia per WHO Classification or chronic myelogenous leukemia lymphoid blast crisis\n4. Primary immunodeficiency\n5. Hereditary diseases (e.g., Fanconi anemia, Kostmann syndrome, and Shwachman-Diamond syndrome) or other bone marrow failure syndromes\n\n2\\. Common Exclusion Criteria\n\nSubjects in Phase 1 study and Phase 2 study may not participate in this trial if any of the following criteria apply.\n\n1. Patients with the following medical history:\n\n   * History of malignancy with the following exceptions:\n\n     • Basal cell or squamous cell skin cancer treated without relapse for at least three years prior to Screening\n\n     • In-situ carcinoma of the cervix or breast treated without relapse for at least 3 years prior to Screening\n     * Superficial bladder cancer treated without relapse for at least 3 years prior to Screening\n     * A primary malignancy which has been completely resected and in complete remission for ≥ 5 years\n\n       * Unstable angina and\u002For myocardial infarction within 12 months prior to Screening ③ Thromboembolic events, pulmonary embolism or bleeding diatheses within 6 months prior to Screening\n\n         * Hypoxemia, clinically significant pleural effusion or clinically significant ECG findings within 6 months prior to Screening\n2. Patients with the following concurrent disease at Screening:\n\n   * Central nervous system (CNS) involvement by malignancy by magnetic resonance imaging (MRI) at Screening. However, for Cohort B, subjects with malignant tumor metastasis to the brain parenchyma confirmed by MRI scan.\n\n     * Active infection with hepatitis B confirmed (HBsAg positive at Screening. But, in case of HBcAb IgG positive, the patient can be enrolled if he\u002Fshe takes prophylactic anti-viral agent.)\n\n       * Active infection with hepatitis C confirmed (HCV Ab tested positive at Screening. But, if screened negative for HCV RNA, the patient can be enrolled.) ④ Known human immunodeficiency virus (HIV) positive ⑤ Active neurological auto-immune or inflammatory disorder (e.g., Guillain Barre syndrome, amyotrophic lateral sclerosis) ⑥ Ventricular tachycardia and atrial fibrillation with rapid ventricular response not controlled (i.e., relapsed or symptomatic) with pharmacological treatment within three months prior to Screening\n3. Showing rapid progression of study disease as per Investigator's discretion\n4. Had major surgery requiring general anesthesia or mechanical ventilation within four weeks prior to Screening (for video-assisted thoracoscopic surgery (VATS) or open-and-closed (ONC) surgery, within two weeks prior to Screening)\n5. Severe infection requiring anti-bacterial, anti-fungal or anti-viral medication or uncontrolled active infection at Screening\n6. Use of other investigational medicinal products\u002Fdevices within 4 weeks prior to Screening\n7. Pregnant or lactating women\n8. Hypersensitivity reaction to the ingredients of the Investigational Product\n\nOther protocol-related inclusion\u002Fexclusion may apply.","19 Years",{"count":563,"type":22},91,[89,58],"This is a multi-center, phase I\u002FII study to determine the efficacy and safety of CRC01 in adult patients with relapsed or refractory large B-cell lymphoma and B-cell Acute Lymphoblastic Leukemia.",[567,568,28,569,570,571,572],"Relapsed Large B-cell Lymphoma","Refractory Large B-cell Lymphoma","Primary Mediastinal Large B-Cell Lymphoma (PMBCL)","High-grade B-cell Lymphoma","Transformed Follicular Lymphoma (TFL)","ALL (Acute B-Lymphoblastic Leukemia)",[574,575,576,577,578,579,580],"CRC01","anti-CD19 CAR-T","CAR-T","CAR T cells","Chimeric antigen receptor","PD-1 knock down","TIGIT knock down",{"date":547,"type":39},{"date":583,"type":39},"2021-03-02",{"date":585,"type":22},"2030-09-26",{"name":587,"class":46},"Curocell Inc.",{"id":589,"slug":590,"hasResults":12,"nctId":591,"briefTitle":592,"officialTitle":593,"acronym":594,"eligibilityCriteria":595,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":596,"targetDuration":4,"studyType":476,"phases":4,"briefSummary":598,"conditions":599,"keywords":600,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":603,"lastUpdatePostDateStruct":604,"startDateStruct":606,"completionDateStruct":608,"leadSponsor":610,"locationsCount":278},"100643890","glofitamab-combined-with-selinexor-in-patients-with-relapsedrefractory-diffuse-large-b-cell-lymphoma-100643890","NCT07669194","Glofitamab Combined With Selinexor in Patients With Relapsed\u002FRefractory Diffuse Large B-cell Lymphoma","Observational Real-World Study of Glofitamab Combined With Selinexor for Patients With Relapsed\u002FRefractory Diffuse Large B-cell Lymphoma (R\u002FR DLBCL)","Glofit-Sel","Inclusion Criteria:\n\n* Age 18 years and older at the time of informed consent.\n* Histologically confirmed CD20+ diffuse large B-cell lymphoma (DLBCL).\n* Relapsed or refractory disease, having previously received at least two lines of systemic therapy.\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2.\n* Presence of measurable disease.\n* Adequate hematologic, hepatic, and renal function.\n* Willingness to use effective contraception methods during the study and for a specified period after the last dose.\n* Willing and able to provide written informed consent and comply with the study protocol.\n\nExclusion Criteria:\n\n* Prior treatment with any CD20\u002FCD3 bispecific antibodies or XPO1 inhibitors.\n* Current or prior history of central nervous system (CNS) involvement by lymphoma or other significant CNS diseases.\n* Active and uncontrolled systemic infections, including known HIV infection, active Hepatitis B virus (HBV), or active Hepatitis C virus (HCV) infection.\n* Active autoimmune diseases requiring systemic immunosuppressive therapy.\n* Clinically significant, severe, or uncontrolled cardiovascular diseases.\n* Other active invasive malignancies within the past 2 years (with exceptions for adequately treated localized cancers).\n* Recent major surgery or receipt of live attenuated vaccines within a specified timeframe prior to the study.\n* Severe gastrointestinal conditions that may significantly affect the absorption of oral medications.\n* Known severe allergic reactions to any of the study drugs or their excipients.\n* Pregnant or breastfeeding women.",{"count":597,"type":22},30,"Assess the efficacy and safety of glofitamab in combination with selinexor for the treatment of relapsed or refractory diffuse large B-cell lymphoma (R\u002FR DLBCL) in patients who have received at least two prior lines of systemic therapy.",[63],[601,405,602],"Relapsed\u002FRefractory","Selinexor","2026-06-22",{"date":605,"type":39},"2026-06-25",{"date":607,"type":22},"2026-06-10",{"date":609,"type":22},"2029-04-30",{"name":611,"class":77},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":613,"slug":614,"hasResults":12,"nctId":615,"briefTitle":616,"officialTitle":617,"acronym":618,"eligibilityCriteria":619,"healthyVolunteers":12,"sex":18,"minAge":620,"maxAge":621,"enrollmentInfo":622,"targetDuration":4,"studyType":476,"phases":4,"briefSummary":624,"conditions":625,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":627,"lastUpdatePostDateStruct":628,"startDateStruct":629,"completionDateStruct":630,"leadSponsor":632,"locationsCount":634},"100641676","neurocognitive-assessment-in-long-term-survivors-of-lymphoma-100641676","NCT07652476","Neurocognitive Assessment in Long-Term Survivors of Lymphoma","Neurocognitive Assessment in Long-Term Survivors of Lymphoma: An Observational Study by the Fondazione Italiana Linfomi (FIL)","FIL_LymDeCo","Inclusion Criteria:\n\n* Patients with previous diagnosis of classic Hodgkin Lymphoma (cHL) or Diffuse Large B Cell Lymphoma (DLBCL) or Primary Mediastinal B Cell Lymphoma (PMBCL).\n* Patients in complete remission after first line anthracycline containing regimen (ABVD, BV-AVD, BEACOPP, R-CHOP, Pola-R-CHP o R-DA-EPOCH) +\u002F- radiotherapy.\n* Age ≥ 25 and ≤ 55 at enrollment.\n* Patients between third and fifth year of follow-up after the end of the first line treatment.\n* Absence of signs or symptoms of disease relapse.\n\nExclusion Criteria:\n\n* Patients with CNS disease localization.\n* Patients that received brain\u002Fneuroaxis radiotherapy.\n* Pre-existing severe psychiatric or neurologic comorbidities influencing neurocognitive assessment.","25 Years","55 Years",{"count":623,"type":22},100,"This is an observational, multicenter, prospective cohort study including patients treated for lymphoma in Italian real-life. Patients eligible for the enrollment in the study will be consecutively included in Italian FIL centers. Patients will be evaluated once during regular follow-up, in the absence of clinical or radiologic signs of disease relapse.\n\nThe assessment of neurocognitive functioning will be performed through a panel of tests, both self-administered and individually administered (about 1 hour). The administration of these neuropsychological tests should be done according to a standardized and predefined order. If available, according to local practice, a neuropsychologist may be involved in test administration and in the evaluation of the results.\n\nBased on its observational nature, no treatment change or modification or additional exams or visits will be required because of being enrolled in this study.",[626,97,96],"Classic Hodgkin Lymphoma","2026-06-17",{"date":603,"type":39},{"date":160,"type":22},{"date":631,"type":22},"2028-03",{"name":633,"class":77},"Fondazione Italiana Linfomi - ETS",7,{"id":636,"slug":637,"hasResults":12,"nctId":638,"briefTitle":639,"officialTitle":640,"acronym":4,"eligibilityCriteria":641,"healthyVolunteers":12,"sex":18,"minAge":642,"maxAge":4,"enrollmentInfo":643,"targetDuration":4,"studyType":23,"phases":645,"briefSummary":646,"conditions":647,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":653,"lastUpdatePostDateStruct":654,"startDateStruct":655,"completionDateStruct":657,"leadSponsor":659,"locationsCount":278},"100642651","phase-1-axatilimab--car-t-for-high-risk-lymphoma-100642651","NCT07638982","Axatilimab + CAR-T for High-Risk Lymphoma","An Open-label, Phase I Trial, With an Expansion Cohort: Macrophage Conditioning to Synergize With CAR-T in High-risk Lymphoma (MAC-SHIFT)","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Histologically confirmed large B-cell lymphoma\n* Presence of one or more high-risk features\n* Eligible to receive CAR-T according to the FDA label\n* Measurable disease by CT or PET\n* Adequate organ function unless related to lymphoma involvement:\n* Pulse oximetry ≥ 92% on room air\n* Ejection Fraction ≥ 40%\n* ALT\u002FAST \\\u003C 5x ULN\n* Bilirubin \\\u003C 3 x ULN\n* Calculated or measured creatinine Clearance ≥ 30 mL\u002Fmin\n\nExclusion Criteria:\n\n* KPS \\\u003C60\n* Second malignancy with a high metastatic potential within 3 years\n* Active CNS involvement. Treated CNS disease is allowed\n* Active HBV or HCV infection.\n* Active uncontrolled infections\n* Known HIV positive status\n* Allogeneic transplant within 100 days of enrollment\n* Active acute or chronic graft versus host disease\n* History of acute or chronic pancreatitis\n* History of myositis","8 Years",{"count":644,"type":22},29,[89],"Axatilimab + CAR-T in High-Risk Lymphoma",[97,648,649,650,651,652],"Transformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma","High-grade B-cell Lymphoma (HGBCL)","High-Grade B-Cell Lymphoma, Nos","PMBCL","Follicular Grade 3 Lymphoma","2026-06-05",{"date":607,"type":39},{"date":656,"type":22},"2026-10-31",{"date":658,"type":22},"2029-12-31",{"name":660,"class":77},"Northside Hospital, Inc.",{"id":662,"slug":663,"hasResults":12,"nctId":664,"briefTitle":665,"officialTitle":665,"acronym":666,"eligibilityCriteria":667,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":668,"targetDuration":4,"studyType":23,"phases":670,"briefSummary":671,"conditions":672,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":673,"lastUpdatePostDateStruct":674,"startDateStruct":676,"completionDateStruct":678,"leadSponsor":679,"locationsCount":278},"100640126","phase-2-efficacy-and-safety-of-polatuzumab-vedotin-in-combination-with-zanubrutinib-rituximab-cyclophosphamide-doxorubicin-and-prednisone-in-patients-with-previously-untreated-diffuse-large-b-cell-lymphoma-of-the-mcdbn2n1-subtypes-100640126","NCT07608978","Efficacy and Safety of Polatuzumab Vedotin in Combination With Zanubrutinib, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone in Patients With Previously Untreated Diffuse Large B-Cell Lymphoma of the MCD\u002FBN2\u002FN1 Subtypes","Pola-ZRCHP","Inclusion Criteria:\n\n* Age ≥18 years at the time of signing informed consent. Histologically confirmed Diffuse Large B-Cell Lymphoma (DLBCL) with MCD\u002FBN2\u002FN1 molecular subtypes defined by LymphGen classification.\n\nPreviously untreated (treatment-naïve). International Prognostic Index (IPI) score of 2-5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. Life expectancy ≥6 months. At least one measurable lesion in two dimensions, defined as a maximum diameter \\>1.5 cm by CT or MRI.\n\nLeft Ventricular Ejection Fraction (LVEF) ≥50% as assessed by echocardiogram (ECHO).\n\nAdequate hematologic function (unless due to underlying disease, e.g., extensive bone marrow involvement, or splenomegaly secondary to splenic involvement deemed by the investigator to be caused by DLBCL; blood product transfusions are allowed), defined as follows:\n\nHemoglobin ≥9.0 g\u002FdL within 7 days prior to first treatment, without packed RBC transfusion.\n\nAbsolute Neutrophil Count (ANC) ≥1.0 × 10⁹\u002FL. Platelet count ≥75 × 10⁹\u002FL. Female participants of childbearing potential: Must agree to abstain from heterosexual intercourse or use contraception, and agree not to donate ova.\n\nMale participants: Must agree to abstain from heterosexual intercourse or use contraception, and agree not to donate sperm.\n\nExclusion Criteria:\n\nContraindication to any component of the Pola-ZRCHP regimen. Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding onychomycosis) at screening, or any major infection occurring within 4 weeks prior to the first dose of study treatment (as judged by the investigator).\n\nSuspected or latent tuberculosis (confirmed by positive IFNγ release assay). Currently pregnant or breastfeeding, or planning a pregnancy during the study period or within 12 months after the last dose.\n\nHistory of confirmed Progressive Multifocal Leukoencephalopathy (PML). Current or history of Central Nervous System (CNS) lymphoma. Evidence of significant, uncontrolled concomitant disease that may affect compliance with the protocol or interpretation of results.\n\nSevere or extensive cardiovascular disease, such as New York Heart Association (NYHA) Class III or IV, or objective assessment of Class C or D cardiac disease; myocardial infarction within the past 6 months; unstable arrhythmias; or unstable angina.\n\nClinically significant liver disease, including active viral hepatitis or other hepatitis, current alcohol abuse, or cirrhosis.\n\nAny of the following abnormal laboratory values (unless these abnormalities are solely attributable to underlying lymphoma):\n\nINR or PT \\>1.5 × Upper Limit of Normal (ULN) in the absence of therapeutic anticoagulation.\n\nPTT or aPTT \\>1.5 × ULN in the absence of lupus anticoagulant. Serum AST and ALT ≥2.5 × ULN. Total bilirubin ≥1.5 × ULN. Estimated creatinine clearance \\\u003C40 mL\u002Fmin (using the Cockcroft-Gault formula). Positive HBV DNA test result. Positive Hepatitis C test result (Hepatitis C virus \\[HCV\\] antibody serology). Note:Patients with positive HCV antibody are eligible only if the PCR test for HCV RNA is negative.\n\nAny other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that gives reasonable suspicion of a disease or condition that contraindicates the use of the investigational drug(s).",{"count":669,"type":22},35,[58],"This is a prospective, open-label, single-arm, single-center, Phase II clinical study designed to evaluate the efficacy and safety of Efficacy and Safety of Polatuzumab Vedotin in Combination With Zanubrutinib, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone in Patients With Previously Untreated Diffuse Large B-Cell Lymphoma of the MCD\u002FBN2\u002FN1 Subtypes.\n\nAfter successful screening, enrolled patients will receive 6 treatment cycles (21 days per cycle). Disease response will be assessed by CT\u002FPET-CT during treatment and after completion of induction. Patients who achieve CR\u002FPR\u002FSD will proceed to the maintenance phase; patients who do not achieve at least SD (i.e., fail to reach CR\u002FPR\u002FSD) during induction will discontinue the study. Patients with CR\u002FPR\u002FSD after induction will receive maintenance therapy with zanubrutinib plus tislelizumab until disease progression, unacceptable toxicity, or completion of 1 year of maintenance.\n\nEfficacy and safety assessments will be performed per protocol. Tumor response will be assessed by site investigators according to the 2014 Lugano criteria, including determination of response status, date of response, and date of progression\u002Frelapse.",[63],"2026-05-20",{"date":675,"type":39},"2026-05-27",{"date":677,"type":22},"2026-06-01",{"date":658,"type":22},{"name":680,"class":77},"The First Affiliated Hospital with Nanjing Medical University",{"id":682,"slug":683,"hasResults":12,"nctId":684,"briefTitle":685,"officialTitle":686,"acronym":4,"eligibilityCriteria":687,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":688,"targetDuration":4,"studyType":23,"phases":690,"briefSummary":691,"conditions":692,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":696,"lastUpdatePostDateStruct":697,"startDateStruct":699,"completionDateStruct":701,"leadSponsor":703,"locationsCount":278},"100639830","phase-1-a-phase--study-of-cs08399-in-participants-with-mtap-deleted-solid-tumors-and-lymphoma-100639830","NCT07583771","A Phase Ⅰ Study of CS08399 in Participants With MTAP-deleted Solid Tumors and Lymphoma","A Phase Ⅰ Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamic and Preliminary Efficacy of CS08399 in Participants With MTAP-deleted Solid Tumors and Lymphoma","Inclusion Criteria:\n\n1. Understand and sign the informed consent form voluntarily.\n2. ≥18 years old when signing the informed consent, regardless of sex.\n3. Histologically or cytologically confirmed locally advanced or metastatic solid tumors, or relapsed\u002Frefractory lymphoma, for which standard therapy has failed or is not tolerated, and no further standard therapy is available. Homozygous MTAP or CDKN2A deletion confirmed by tissue or peripheral blood testing.\n4. For glioblastoma: at least one measurable intracranial tumor lesion according to the RANO 2.0 criteria. For other solid tumors: at least one measurable lesion according to RECIST v1.1 criteria. For lymphoma: at least one measurable lesion according to Lugano 2014 criteria.\n5. For glioblastoma: KPS score ≥60. For other solid tumors and lymphoma: ECOG performance status of 0 or 1.\n6. Adequate organ function.\n7. Life expectancy ≥3 months.\n8. Able to swallow and retain oral study medication.\n\nExclusion Criteria:\n\n1. Received any anti-tumor therapy (including but not limited to chemotherapy, targeted therapy, anti angiogenic therapy, immunotherapy, cell therapy, radiotherapy, tumor embolization, etc.) or experimental drugs\u002Fdevices that have not been approved for marketing within 28 days prior to the first dose or are still within 5 half-lives of such drugs (whichever is shorter).\n2. Previously received MAT2A or PRMT5 inhibitors.\n3. Underwent major surgery (cranial, thoracic, or abdominal) within 28 days prior to the first dose or have unresolved wounds, ulcers, or fractures.\n4. Have unresolved toxicities from previous treatments that have not recovered to CTCAE v5.0 grade ≤1.\n5. History of other primary malignancies within 5 years prior to the first dose.\n6. For solid tumors : The presence of active, clinically symptomatic central nervous system metastases or leptomeningeal metastases or spinal cord compression at screening.\n7. Primary central nervous system lymphoma or systemic lymphoma with CNS involvement.\n8. Evidence of interstitial lung disease, pulmonary fibrosis, or non-infectious pneumonitis requiring treatment on chest imaging at screening.\n9. Active infection requiring systemic anti-infective treatment at screening.\n10. Received drainage of pleural effusion, ascites, or pericardial effusion within 1 month prior to the first dose or have significant clinical symptoms.\n11. Uncontrolled or significant cardiovascular disease.\n12. Poorly controlled diabetes.\n13. Significant gastrointestinal abnormalities at screening that may affect drug intake, transport, or absorption.\n14. History of gastrointestinal perforation, fistula, peptic ulcer, bowel obstruction, or biliary obstruction within 6 months prior to the first dose.\n15. Clinically significant hemoptysis or tumor bleeding within 14 days prior to the first dose; significant active bleeding within 2 months prior to the first dose; currently on anticoagulants; high-risk bleeding tendency at screening.\n16. Serious thromboembolic events within 6 months prior to the first dose.\n17. Active tuberculosis at screening.\n18. Active hepatitis B or hepatitis C at screening.HIV infection or syphilis infection at screening.\n19. Allergy or hypersensitivity to any component of the trial drug or known excipients, or history of severe allergic diseases.\n20. History of organ transplantation or allogeneic hematopoietic stem cell transplantation.\n21. History of alcohol abuse or drug abuse.\n22. Any psychiatric or cognitive disorder that may limit understanding of informed consent, compliance with the protocol, or participation in the trial.\n23. Pregnant or breastfeeding women.\n24. Other conditions deemed unsuitable for participation in this trial by the investigator.",{"count":689,"type":22},186,[89],"This is a phase I, open-label, first-in-human study of CS08399, comprising two phases: dose escalation (including single-dose and multiple-dose) and cohort expansion. The primary objectives of this study are to evaluate the safety, tolerability and pharmacokinetic (PK) characteristics of CS08399 in participants with MTAP-deleted solid tumors and Lymphoma, and to recommended Phase 2 dose(s) (RP2D) of CS08399 in appropriate tumor(s).",[693,694,695,237,63],"Pancreatic Adenocarcinoma","Non Small Cell Lung Cancer","Advanced Solid Tumors","2026-05-07",{"date":698,"type":39},"2026-05-13",{"date":700,"type":22},"2026-06",{"date":702,"type":22},"2030-01",{"name":704,"class":46},"Chipscreen Biosciences, Ltd."]