[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapsedrefractory-diffuse-large-b-cell-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapsedrefractory-diffuse-large-b-cell-lymphoma":117},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,45,78,104,134],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100576973","phase-3-study-comparing-bebt-908-combined-with-r-to-soc-for-the-treatment-of-relapsedrefractory-diffuse-large-b-cell-lymphoma-100576973",false,"NCT06792253","Study Comparing BEBT-908 Combined With R to SOC for the Treatment of Relapsed\u002FRefractory Diffuse Large B-Cell Lymphoma","Phase Ⅲ Clinical Trial Comparing BEBT-908 Combined With Rituximab (R) to Standard of Care for the Treatment of Relapsed\u002FRefractory Diffuse Large B-Cell Lymphoma","Inclusion Criteria:\n\n1. The subject has been fully informed and is willing to sign the Informed Consent Form (ICF).\n2. Age is ≥18 years and ≤75 years, both men and women are eligible.\n3. Pathologically diagnosed as diffuse large B-cell lymphoma according to the 2022 World Health Organization classification, confirmed by central pathology review (Patients who relapse after more than one year need to undergo tissue biopsy again to confirm the pathological diagnosis.).\n4. Measurable lesions \\[The criteria for measurable lesions are: the longest diameter of lymph node lesions measured by enhanced Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) is greater than 15 mm, and the longest diameter of extranodal lesions is greater than 10 mm.\\] assessed by Positron Emission Tomography\u002FComputed Tomography (PET-CT) and Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) according to the Lugano 2014 criteria .\n5. Must have relapsed or refractory diffuse large B-cell lymphoma after at least one systemic therapy \\[Salvage chemotherapy and immunotherapy after stem cell transplantation will be considered as first-line systemic treatment; maintenance therapy will not be counted as a separate line of systemic treatment; local radiotherapy for diffuse large B-cell lymphoma (DLBCL) aimed at cure will not be counted as first-line systemic treatment; patients who do not achieve PR after four cycles of first-line treatment are eligible for the study; patients who do not achieve PR after two cycles of second-line or higher treatment are eligible for the study. Primary refractory DLBCL patients are defined as those who have no response during first-line treatment or relapse within six months after the end of treatment, and they will be allowed to participate in the study. Patients who relapse within 12 months after stem cell transplantation are also eligible for inclusion. Refractory DLBCL patients are those who do not achieve response after adequate front-line treatment (at least four cycles of first-line chemotherapy, or at least two cycles of subsequent treatment), or who progress during previous first-line treatment, or who progress within six months (less than six months) after achieving response to previous adequate front-line treatment, or who relapse within 12 months after achieving response to stem cell transplantation. Relapsed DLBCL patients are those who relapse six months or more after achieving response to previous adequate front-line treatment, or who relapse 12 months or more after achieving response to stem cell transplantation.\\], and at least one systemic therapy must include CD20 antibody.\n6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.\n7. Expected survival \\>12 weeks.\n8. Organ function levels must meet the following requirements:\n\nPeripheral blood:\n\n1. Absolute neutrophil count (ANC) ≥1.0×10\\^9\u002FL;\n2. Hemoglobin (HGB) ≥80g\u002FL;\n3. Platelet count (PLT) ≥100×10\\^9\u002FL;\n\nLiver and kidney function:\n\n1. Serum total bilirubin ≤1.5×Upper Limit of Normal (ULN) (for patients with Gilbert syndrome, total bilirubin \\\u003C3.0×ULN with direct bilirubin within normal range);\n2. Serum creatinine \\\u003C1.5×ULN;\n3. Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) ≤2.5×ULN (≤5×ULN if there is liver involvement).\n\nExclusion Criteria:\n\n1. Known severe allergy to the study drug or any of its excipients;\n2. Due to the potential genotoxicity, mutagenicity, and teratogenicity of the study drug, the following subjects should be excluded:\n\n   1. Men and women who have not undergone in vitro preservation of sperm or oocytes and plan to have children within 5 years, unless subsequent studies confirm reproductive safety;\n   2. Pregnant or breastfeeding women;\n3. Primary central nervous system lymphoma;\n4. DLBCL with active central nervous system brain metastases or meningeal involvement at the time of screening;\n5. Other active malignant tumors that require treatment and may interfere with the study.\n6. Treatment history before the trial:\n\n   1. Received other small molecule targeted drug therapy within 2 weeks before enrollment;\n   2. Previously received BEBT-908 or R-ICE and R-GemOx therapy before enrollment;\n   3. Underwent autologous hematopoietic stem cell transplantation within 3 months before enrollment;\n   4. Received radiotherapy that affects the evaluation of the efficacy of this study within 3 months before enrollment, or local supportive radiotherapy that affects the subject's bone marrow function;\n   5. Underwent myelosuppressive chemotherapy or biological therapy within 3 weeks before enrollment;\n   6. Used traditional Chinese medicine and patent medicine with antitumor effects within 2 weeks before enrollment;\n   7. Underwent major surgery (Referring to the Level 3 and Level 4 surgeries as stipulated in the \"Administrative Measures for the Clinical Application of Medical Technologies\" implemented on May 1, 2009.) other than tumor biopsy within 4 weeks before enrollment, or the side effects of the surgery have not yet stabilized;\n   8. Received any hematopoietic cell colony-stimulating factor therapy (such as granulocyte colony-stimulating factor G-CSF, granulocyte-macrophage colony-stimulating factor GM-CSF) or thrombopoietin TPO therapy (Subjects who have started receiving erythropoiesis-stimulating agents or darbepoetin within 2 weeks prior to enrollment are eligible for inclusion.) within 2 weeks before enrollment;\n   9. Received prednisone \\>10mg per day (or other equivalent doses of glucocorticoids) within 7 days before enrollment \\[If used for the treatment of diseases other than lymphoma, such as rheumatoid arthritis, polymyalgia rheumatica, adrenal insufficiency, or asthma, subjects may receive a stable dose of up to 10 mg per day of prednisone (or an equivalent dose of other glucocorticoids).\\];\n   10. Underwent chimeric antigen receptor T cell immunotherapy (CAR-T therapy) within 3 months before enrollment.\n7. After the previous treatment (chemotherapy or biological therapy), there are persistent Grade 2 or higher \\[Common Terminology Criteria for Adverse Events (CTCAE) V5.0 criteria\\] toxicities that have not stabilized at the time of enrollment (alopecia excluded);\n8. There is an active clinical severe infection of Grade 2 or higher (CTCAE V5.0 criteria);\n9. Co-morbid conditions:\n\n   1. Poorly controlled diabetes mellitus \\[with a random blood glucose level ≥11.1 mmol\u002FL or Glycosylated Hemoglobin, Type A1C (HbA1c) ≥8.5% despite hypoglycemic treatment\\];\n   2. Severe pulmonary disease (CTCAE V5.0 Grade III-IV);\n   3. Severe cardiac disease \\[Including any of the following: left ventricular ejection fraction (LVEF) \\\u003C50% detected by cardiac radionuclide scan \\[Multigated Acquisition (MUGA)\\] or echocardiogram (ECHO); Fridericia-corrected QT value (QTcF interval) \\>450ms for males and \\> 470ms for females (QTcF formula); unstable angina; symptomatic pericarditis; myocardial infarction within the past 6 months with persistent elevation of cardiac enzymes or persistent regional left ventricular wall abnormalities recorded during LVEF measurement; history of congestive heart failure (New York Heart Association Class III-IV), or history of cardiomyopathy.\\].\n   4. Significant renal or hepatic dysfunction;\n   5. Uncontrolled active hepatitis B, hepatitis C, syphilis (individuals with both specific and non-specific syphilis antibodies positive), and active Epstein-Barr virus infection \\[The following active infections with clinical significance, including hepatitis B (HBV), hepatitis C (HCV), and syphilis. Active hepatitis B is defined as: hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg) or hepatitis B core antibody positive, and HBV DNA ≥ 2000 IU\u002Fml (approximately equal to 10\\^4 copies\u002Fml), hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg) positive, HBV DNA \\\u003C 2000 IU\u002Fml, according to the requirements of infectious disease control, the subject should continue to take antiviral drug treatment); active hepatitis C is defined as: HCV RNA above the upper limit of detection; positive syphilis spirochete antibody test, should be tested for non-specific syphilis spirochete antibodies \\[Rapid Plasma Reagin Test (PRP) or Toluidine Red Unheated Serum Test (TRUST)\\], the latter is negative and the subject is judged by the researcher to have been infected with syphilis in the past but has been cured can be included; current EB virus infection refers to EB virus serological detection of Epstein-Barr Virus Capsid Antigen Immunoglobulin M (VCA-IgM), Epstein-Barr Virus Early Antigen Immunoglobulin G (EA-IgG) positive or EB virus DNA test positive.\\];\n   6. Known positive for human immunodeficiency virus (HIV);\n   7. History of mental illness, family history of mental illness, or mood disorders as judged by the investigator or psychiatrist \\[Including a medical history of depressive episodes, bipolar disorder (Type I or II), obsessive-compulsive disorder, schizophrenia, suicide attempts or suicidal ideation, or thoughts of killing (immediate risk of harming others), and anxiety levels above Grade 3.\\], and deemed unsuitable for enrollment by the investigator;\n   8. Need for concomitant anticoagulant or antiplatelet therapy during the study period;\n   9. Uncontrolled hypertension (systolic blood pressure ≥180 mmHg and\u002For diastolic blood pressure ≥110 mmHg);\n   10. Severe internal medical conditions with a risk of major bleeding or a history of major bleeding.\n10. Concurrent use of drugs that may cause QT interval prolongation or torsades de pointes;\n11. Within 4 weeks prior to enrollment, currently receiving or requiring treatment with strong inhibitors or inducers of cytochrome P450 (CYP) 3A4 isoenzyme after enrollment (Within 4 weeks prior to enrollment and during the study period, subjects must not receive treatment with strong inhibitors or inducers of the cytochrome P450 (CYP) 3A4 isoenzyme. However, concurrent treatment with moderate or weak CYP3A4 inhibitors is permitted.);\n12. Within 4 weeks prior to enrollment, participated in other clinical trials and used investigational drugs;\n13. Any unstable condition or situation that may jeopardize the subject's safety and compliance with the study as judged by the investigator;\n14. Subjects deemed unsuitable for treatment with this protocol by the investigator.","ALL","18 Years","75 Years",{"count":20,"type":21},416,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This is a multicenter, randomized, controlled, open-label Phase III clinical trial, aimed at evaluating the efficacy and safety of BEBT-908 combined with rituximab (R) compared to investigator-selected standard chemotherapy regimens \\[Standard of Care (SOC)\\] \\[i.e., rituximab-gemcitabine-oxaliplatin (R-GemOx) or rituximab-ifosfamide-carboplatin-etoposide (R-ICE)\\] for the treatment of relapsed\u002Frefractory diffuse large B-cell lymphoma (r\u002Fr DLBCL).",[27],"Relapsed\u002FRefractory Diffuse Large B-Cell Lymphoma",[29,30,31],"BEBT-908","Efficacy","Safety","RECRUITING","2026-08-17",{"date":35,"type":36},"2026-08-19","ACTUAL",{"date":38,"type":36},"2025-01-06",{"date":40,"type":21},"2029-06-30",{"name":42,"class":43},"BeBetter Med Inc","INDUSTRY",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":22,"phases":54,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":44},"100650488","phase-2-glofitamab-in-b-nhl-using-mid-therapy-intratumoral-transcriptomics-100650488","NCT07748364","Glofitamab in B-NHL Using Mid-Therapy Intratumoral Transcriptomics","Phase II Trial of Glofitamab in B-NHL Using Mid-Therapy Intratumoral Transcriptomics","Inclusion Criteria:\n\n* Patients with pathologically confirmed diagnosis of aggressive CD20(+) B-NHL,\n* including DLBCL and MCL.\n* Stage II, III or IV by Ann Arbor Classification.\n* Superficially accessible lesion for core-needle biopsy, e.g. cervical, axillary,\n* inguinal, subcutaneous.\n* Disease that has progressed (clinically or radiographically) after standard-of-care\n* prior therapy, including anthracycline-based therapy for DLBCL and anti-CD20\n* mAb-based therapy for all histologies.\n\nExclusion Criteria:\n\nPatients who meet any of the following criteria will be excluded from study entry:\n\n* Contraindication to any of the individual components of glofitamab or history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products\n* Any prior treatment with a BsAb targeting CD3 and CD20\n* Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation\n* 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\n* Treatment with CAR-T therapy within 30 days prior to first dose of glofitamab\n* Any investigational therapy for the purposes of treating cancer within 28 days prior to the start of Cycle 1\n* Prior radiotherapy to the mediastinal\u002Fpericardial region Radiotherapy to non-target lesion sites will be permitted.\n* Corticosteroid use \\>50 mg\u002Fday of prednisone or equivalent, for purposes other than lymphoma symptom control\n\n  * 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 1.\n\n    * Corticosteroid therapy for control of cancer symptoms or side effects of prior treatment (e.g., nausea or B-symptoms) is permitted.\n    * The use of inhaled corticosteroids is permitted.\n    * The use of mineralocorticoids for management of orthostatic hypotension is permitted.\n    * The use of physiologic doses of corticosteroids for management of adrenal insufficiency is permitted.\n  * Participants who require lymphoma symptom control during screening may receive steroids in the following manner:\n\n    * Up to 50 mg\u002Fday of prednisone or equivalent may be used for lymphoma symptom control during screening, including prior to finalization of staging (not included as part of pre-phase treatment).\n    * If glucocorticoid treatment is urgently required at higher doses for lymphoma symptom control prior to the start of study treatment, tumor assessments must be completed prior to initiation of 50-100 mg\u002Fday of prednisone or equivalent. Prednisone 50-100 mg\u002Fday or equivalent may be given for a maximum of 10-14 days as a pre-phase treatment. As part of the pre-phase treatment, vincristine may not be administered.\n* History of other malignancy that could affect compliance with the protocol or interpretation of results:\n\n  * 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  * 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  * 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* 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\n* Recent major surgery (within 4 weeks prior to the start of Cycle 1), other than for diagnosis\n* Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis or neurodegenerative disease Participants with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 2 years and have no residual neurological deficits, as judged by the investigator, are allowed.\n* Current or past history of CNS lymphoma\n* Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)\n* Current or past history of Waldenström macroglobulinemia\n* History or presence of an abnormal ECG that is clinically significant in the investigator's opinion\n* Patients with known or suspected active infection, or reactivation of a latent infection, whether bacterial, viral (including, but not limited to, SARS-Cov-2, Epstein-Barr virus (EBV), cytomegalovirus (CMV), hepatitis B, and hepatitis C), fungal, mycobacterial, or other pathogens (excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with IV antibiotics (for IV antibiotics this pertains to completion of last course of antibiotic treatment) within 4 weeks of dosing\n* History of treatment-emergent immune-related adverse events associated with prior immunotherapeutic agents, as follows:\n\n  * Grade 3 or higher adverse events with the exception of Grade 3 endocrinopathy managed with replacement therapy.\n  * Grade 1-2 adverse events that did not resolve to baseline after treatment discontinuation.\n* Clinically significant liver disease, including active viral or other hepatitis or cirrhosis\n* Illicit drug or alcohol abuse within 12 months prior to screening, in the investigator's judgment\n* Any of the following abnormal laboratory values (unless any of these abnormalities are due to underlying lymphoma):\n\n  * INR or PT \\> 1.5 x upper limit of normal (ULN) in the absence of therapeutic anticoagulation.\n  * PTT or aPTT \\>1.5 x ULN in the absence of a lupus anticoagulant.\n  * Serum AST and ALT \\>2.5 x ULN.\n  * Total bilirubin \\>1.5 x ULN. Participants with documented Gilbert disease may be enrolled if total bilirubin is \\> 3.0 x ULN.\n* 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 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.\n* Suspected active or latent tuberculosis (as confirmed by a positive interferon-gamma release assay)\n* Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen \\[HBsAg\\] serology) 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* Positive test results for hepatitis C (hepatitis C virus \\[HCV\\] antibody serology testing) Participants positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.\n* Positive test results for HTLV-1\n* Participants with a history of progressive multifocal leukoencephalopathy\n* Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 18 months after pretreatment with obinutuzumab or 2 months after the final dose of glofitamab, whichever is longer\n* Positive SARS-CoV-2 test within 7 days prior to enrollment. Rapid antigen test result is also acceptable.",{"count":53,"type":21},16,[55],"PHASE2","This trial will enroll patients with relapsed\u002Frefractory DLBCL and MCL, with the opportunity to receive single-agent glofitamab as early as the second-line. Patients will have superficially accessible disease to enable core-needle biopsy prior to therapy initiation, and on cycle 1 day 15 and cycle 2 day 1 of therapy administration to enable high throughput molecular profiling of disease and immune dynamics while on treatment.",[58,59],"Relapsed\u002FRefractory Diffuse Large B-cell Lymphoma","Relapsed\u002FRefractory Mantle Cell Lymphoma",[61,62,63,64,65,66],"DLBCL (diffuse large B-cell lymphoma)","MCL (mantle cell lymphoma)","relapsed","refractory","GLOFITAMAB","TRANSCRIPTOMICS","NOT_YET_RECRUITING","2026-07-31",{"date":70,"type":36},"2026-08-05",{"date":72,"type":21},"2026-09",{"date":74,"type":21},"2027-07",{"name":76,"class":77},"Joshua Brody","OTHER",{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":88,"conditions":89,"keywords":90,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":103},"100624422","phase-3-a-phase-iii-study-of-hmpl-760-plus-r-gemox-vs-placebo-plus-r-gemox-in-relapsedrefractory-dlbcl-100624422","NCT07409428","A Phase III Study of HMPL-760 Plus R-GemOx VS Placebo Plus R-GemOx in Relapsed\u002FRefractory DLBCL","A Phase III Randomized, Double-Blind, Positive Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of HMPL-760 in Combination With R-GemOx Versus Placebo in Combination With R-GemOx in Patients With Relapsed\u002FRefractory Diffuse Large B-Cell Lymphoma (DLBCL)","Inclusion Criteria:\n\n1. Sign the ICF and be able to follow the requirements of study protocol;\n2. Age ≥18 years;\n3. ECOG performance status score between 0 and 2;\n4. Histopathologically confirmed diagnosis of DLBCL;\n5. The investigator judges that the patient's current condition requires further treatment;\n6. Patients should have at least one bi-dimensionally measurable lesion;\n7. Expected survival is more than 12 weeks;\n\nExclusion Criteria:\n\n1. Patients with known primary or secondary central nervous system lymphoma (CNSL) or the presence of clinical symptoms suggestive of CNSL;\n2. Women who are pregnant (positive pregnancy test during the screening period) or breastfeeding;\n3. Organ insufficiency;\n4. Currently known history of liver disease, including cirrhosis, alcoholic liver, known active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV);\n5. History of significant organ bleeding, including gastrointestinal bleeding, hematencephalon, haemoptysis, etc., within 8 weeks prior to the first dose of study drug;\n6. Known risk of bleeding, such as coagulation factor deficiency, vascular hemophilia; or the patient is receiving vitamin K antagonist (warfarin);\n7. The toxic reactions of previous anti-tumor therapy have not recovered to the level of ≤ grade 1 (except for alopecia and decreased appetite and other conditions that have been clearly required in the inclusion and exclusion criteria);\n8. Clinically significant active infection;",{"count":86,"type":21},240,[24],"This is a Phase III randomized, double-blind, positive controlled study to evaluate the efficacy, safety, and pharmacokinetics of HMPL-760 in combination with R-GemOx versus placebo in combination with R-GemOx in patients with R\u002FR DLBCL.",[27],[91,92,93],"HMPL-760","R-GemOx (rituximab, gemcitabine, and oxaliplatin)","R\u002FR DLBCL","2026-07-17",{"date":96,"type":36},"2026-07-20",{"date":98,"type":36},"2026-03-20",{"date":100,"type":21},"2028-12-30",{"name":102,"class":43},"Hutchmed",50,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":111,"enrollmentInfo":112,"targetDuration":4,"studyType":22,"phases":114,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":44},"100627670","phase-2-low-dose-epcoritamab-plus-gemox-in-rr-dlbcl-100627670","NCT07451652","Low Dose Epcoritamab Plus GemOx in R\u002FR DLBCL","Low Dose Epcoritamab Plus Gemcitabine\u002FOxaliplatin in Treatment of Transplant Eligible Patients With Relapsed\u002FRefractory Diffuse Large B-cell Lymphoma","Inclusion Criteria:\n\n* Subjects with relapsed\u002Frefractory diffuse large B-cell lymphoma who have received at least 1 previous line of treatment and that are candidates to autologous stem cell transplant\n* ECOG 0-2\n* Women of reproductive age who agree on getting a contraceptive method\n* Subjects who fulfill Lugano´s criteria for disease activity\n* Subjects who voluntarily accept to participate in this study\n\nExclusion Criteria:\n\n* Active bacterial, viral or fungal infection\n* Subjects who have already received an autologous o allogeneic stem cell transplantation\n* Subjects with other active neoplasias\n* Subjects with end-stage failure","65 Years",{"count":113,"type":21},10,[55],"In this study, researchers are looking to determine whether Gemcitabine\u002FOxaliplatin plus a lower dose of Epcoritamab (12 mg) works to treat subjects with relapsed\u002Frefractory diffuse large B-cell lymphoma, who are candidates to autologous stem cell transplantation.",[117],"Relapsed\u002FRefractory Diffuse Large B Cell Lymphoma",[119,120,121,122,123,124],"relapsed\u002Frefractory diffuse large B cell lymphoma","epcoritamab","GemOx","gemcitabine","oxaliplatin","autologous stem cell transplant","2026-03-26",{"date":127,"type":36},"2026-04-01",{"date":129,"type":36},"2026-03-17",{"date":131,"type":21},"2027-09",{"name":133,"class":77},"Hospital Universitario Dr. Jose E. Gonzalez",{"id":135,"slug":136,"hasResults":11,"nctId":137,"briefTitle":138,"officialTitle":139,"acronym":4,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":141,"targetDuration":4,"studyType":22,"phases":143,"briefSummary":145,"conditions":146,"keywords":147,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":44},"100585411","phase-1-safety-and-efficacy-of-early-second-infusion-of-axi-cel-based-on-ctdna-for-rr-large-b---cell-lymphoma-100585411","NCT06902012","Safety and Efficacy of Early Second Infusion of Axi-cel Based on ctDNA for R\u002FR Large B - Cell Lymphoma","A Prospective, Single - Arm Clinical Study on the Safety and Efficacy of Early Second Infusion of CD19 CAR - T Based on ctDNA Monitoring in the Treatment of Relapsed\u002FRefractory Large B - Cell Lymphoma","Inclusion Criteria:\n\n1. Age ≥18 years, regardless of gender.\n2. Life expectancy \\>12 weeks.\n3. ECOG performance status 0-2.\n4. Histologically or cytologically confirmed B-cell non-Hodgkin lymphoma per WHO 2016 classification, including:\n\n   Diffuse large B-cell lymphoma (DLBCL) Primary mediastinal large B-cell lymphoma (PMBCL) Transformed follicular lymphoma (TFL) High-grade B-cell lymphoma (HGBCL).\n5. Relapsed\u002Frefractory disease, defined as:\n\n   ≥1 prior relapse, Failure to achieve partial response (PR) after 2-3 cycles of first-line therapy, Failure to achieve complete response (CR) after 4-6 cycles of first-line therapy, Primary refractory disease, Secondary refractory disease, Disease progression following last line of therapy.\n6. Adequate venous access for leukapheresis, with:\n\n   Hemoglobin ≥80 g\u002FL, Absolute neutrophil count ≥1.0 ×10⁹\u002FL, Platelet count ≥75 ×10⁹\u002FL, OR parameters not meeting above thresholds but deemed acceptable for mononuclear cell collection per investigator's judgment.\n7. ≥1 measurable lesion per Lugano 2014 response criteria.\n8. Organ function requirements:\n\n   Renal: Serum creatinine ≤2×ULN OR creatinine clearance ≥40 mL\u002Fmin (Cockcroft-Gault formula).\n\n   Cardiopulmonary:\n\n   Left ventricular ejection fraction (LVEF) \\>50%, Baseline oxygen saturation \\>92% on room air.\n\n   Hepatic:\n\n   Total bilirubin ≤2×ULN (≤5×ULN in Gilbert syndrome), ALT\u002FAST ≤3×ULN (≤5×ULN in patients with hepatic involvement).\n9. Negative serum pregnancy test for women of childbearing potential (WOCBP). Postmenopausal (≥2 years since last menses) or surgically sterilized women are exempt.\n10. Within 60 days post-axi-cel:\n\nPersistent ctDNA(+) or ctDNA(-→+) under CR or PET\u002FCT-confirmed PR\n\nExclusion Criteria:\n\n1. History of malignancies other than DLBCL, PMBCL, TFL, or HGBCL within 5 years prior to screening, except:\n\n   Adequately treated carcinoma in situ of the cervix, Basal cell or squamous cell carcinoma of the skin, Localized prostate cancer after definitive resection, Ductal carcinoma in situ of the breast after curative surgery, Thyroid cancer after radical treatment.\n2. Unstable systemic diseases, including but not limited to:\n\n   Active infections (excluding localized infections), Unstable angina, Cerebrovascular accident or transient ischemic attack (within 6 months prior to screening), Myocardial infarction (within 6 months prior to screening), Congestive heart failure (NYHA Class ≥III), Severe arrhythmia requiring pharmacologic management, Hepatic, renal, or metabolic disorders.\n3. Conditions affecting informed consent or protocol compliance:\n\n   Physical or psychological disorders impairing the ability to provide written informed consent, Inability or unwillingness to comply with study requirements.\n4. Grade ≥3 cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) following prior axi-cel therapy.\n5. Active, uncontrolled serious infections.\n6. Uncontrolled active comorbidities that preclude study participation.\n7. Other conditions deemed by the investigator to confer unacceptable risk or render the patient ineligible.",{"count":142,"type":21},15,[144,55],"PHASE1","The goal of this clinical trial is to evaluate the efficacy and safety of early secondary infusion of CD19 CAR T-cell therapy in adults with relapsed\u002Frefractory diffuse large B-cell lymphoma (DLBCL), guided by ctDNA monitoring. The main questions it aims to answer are:\n\n1. Efficacy: Does early secondary CAR-T infusion improve the 3-month complete remission (CR) rate and long-term survival outcomes (e.g., 1-year PFS, OS)?\n2. Safety: What are the adverse events associated with secondary CAR-T infusion, such as cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity (ICANS), and infections?\n\nThis is a single-arm, single-center, prospective study. All participants will receive:\n\n* Leukapheresis to collect T cells for CAR-T manufacturing.\n* Preconditioning chemotherapy (fludarabine and cyclophosphamide) to prepare the body for CAR-T infusion.\n* Two CD19 CAR-T infusions: The first infusion (2×10⁶ cells\u002Fkg) followed by a second infusion (same dose) if ctDNA remains positive when PET\u002FCT shows CR or PET\u002FCT shows PR within 60 days post-first infusion.\n\nParticipants will undergo:\n\n* Frequent hospital monitoring for ≥14 days post-infusion to manage potential toxicities.\n* Regular follow-ups (e.g., blood tests, ctDNA analysis, PET\u002FCT scans) at scheduled intervals up to 12 months.\n* Continuous safety assessments, including CRS grading, neurological evaluations, and infection monitoring.",[58],[148,149,150],"CAR-T","LYMPHOMA","SENCOND INFUSION","2025-03-24",{"date":153,"type":36},"2025-03-30",{"date":155,"type":21},"2027-02",{"date":157,"type":21},"2028-08",{"name":159,"class":77},"Zhujiang Hospital"]