[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"b-cell-lymphomas\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:b-cell-lymphomas":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100498652","phase-1-a-phase-1-study-of-jv-213-autologous-cd79b-targeting-chimeric-antigen-receptor-t-cell-therapy-in-adults-with-relapsed-or-refractory-b-cell-lymphomas-100498652",false,"NCT05773040","A Phase 1 Study of JV-213 Autologous CD79b-targeting Chimeric Antigen Receptor T-cell Therapy in Adults With Relapsed or Refractory B-cell Lymphomas","Inclusion Criteria:\n\nPatients must meet the following inclusion criteria in order to be eligible for participation in this trial:\n\n1. For the dose escalation cohort: Eligible patients will include those with r\u002Fr B-cell lymphoma including LBCL (DLBCL, HGBCL, LBCL transformed from indolent lymphoma, and PMBCL), FL, marginal zone lymphoma, and MCL after at least 2 prior systemic therapies and Burkitt lymphoma after at least 1 prior systemic therapy. For the dose expansion cohort: Patients with r\u002Fr LBCL (DLBCL, HGBCL, LBCL transformed from indolent lymphoma, and PMBCL) and FL grade 3B will be eligible\n2. Received at least 2 prior lines of therapy, including anti-CD20 antibody and anthracycline therapy for LBCL, anti-CD20 antibody and alkylating agent or lenalidomide therapy for FL, anti-CD20 antibody and alkylating agent or lenalidomide or BTK inhibitor therapy for marginal zone lymphoma, and anti-CD20 antibody and alkylating agent or BTK inhibitor therapy for MCL. Patients with Burkitt lymphoma may be eligible after 1 line of prior therapy including anti-CD20 antibody and anthracycline therapy.\n3. Patients who have received prior CD19 CAR cell therapy using FMC63 antibody for targeting CD19 are eligible and must be at least 6 weeks post CAR infusion and have \\\u003C5% of peripheral blood T cells expressing the prior CAR by flow cytometry assessment.\n4. ≥18 years of age\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n6. At least one measurable lesion per the Lugano 2014 Classification53\n7. At least two weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic anti-cancer therapy prior to leukapheresis. For patients treated with monoclonal antibody-based therapies, at least 4 weeks must have elapsed prior to leukapheresis.\n8. Toxicities due to prior therapy must be stable and recovered to ≤grade 1 (except for clinically non-significant toxicities such as alopecia)\n9. Absolute neutrophil count of ≥1.0×10\\^9\u002FL\n10. Absolute lymphocyte count of ≥0.1×10\\^9\u002FL\n11. Platelet count of ≥75×10\\^9\u002FL\n12. Creatinine clearance (as estimated by Cockcroft Gault) ≥45 mL\u002Fmin\n13. Serum alanine transaminase (ALT) \u002F aspartate transaminase (AST) ≤5 times the upper limit of normal (ULN)\n14. Total bilirubin ≤2 mg\u002FdL, except in patients with Gilbert's syndrome.\n15. Cardiac ejection fraction ≥45% with no evidence of clinically significant pericardial effusion\n16. Baseline oxygen saturation ≥92% on room air\n17. Women of childbearing potential must have a negative serum or urine pregnancy test (women who have had hysterectomy and women who are over the age of 45 years and\n\nExclusion Criteria:\n\nPatients will be excluded from participating in the trial if he\u002Fshe has:\n\n1. Active central nervous system (CNS) lymphoma including patients with detectable cerebrospinal fluid malignant cells or brain metastases. Patients with prior CNS lymphoma that has been effectively treated will be eligible if treatment was completed at least one year prior to enrolment and there is no evidence of disease on MRI with gadolinium contrast at the time of screening.\n2. Any CAR cell therapy using non-FMC63 antibody.\n3. History of Richter's transformation of chronic lymphocytic leukemia\n4. Autologous stem cell transplantation within 6 weeks.\n5. Allogeneic stem cell transplantation within 3 months or active graft versus host disease.\n6. Active autoimmune disease (e.g. Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) requiring systemic immunosuppression\u002Fsystemic disease modifying agents within the last 1 year or inflammatory disease (including graft versus host disease) requiring systemic immunosuppressive therapy. Physiological replacement of corticosteroids of up to 7.5 mg of prednisone or equivalent per day, and topical and inhaled corticosteroids are permitted.\n7. History of any form of primary immunodeficiency that in the opinion of the investigator may affect efficacy of the CAR-T product.\n8. History of any one of the following cardiovascular conditions within the past 6 months: Class III or IV heart failure as defined by the New York Heart Association, cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac disease.\n9. History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) unless disease free for at least 2 years and treated with curative intent. Patients with a prior history of malignancy whose natural history or treatment (e.g. hormonal therapy) does not have the potential to interfere with either the safety or efficacy assessment of the investigational regimen in the opinion of the investigator may be included.\n10. Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous antimicrobials for management. Simple urinary tract infection and uncomplicated bacterial pharyngitis or localized skin infections are permitted if responding to active treatment and after consultation with the Principal Investigator.\n11. Known history of infection with HIV or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). A history of hepatitis B or hepatitis C is permitted if the viral load is undetectable per quantitative PCR and\u002For nucleic acid testing.\n12. History or presence of CNS disorders such as seizure disorder, cerebrovascular ischemia\u002Fhemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement\n13. Patients with cardiac atrial or cardiac ventricular lymphoma involvement\n14. Requirement for urgent therapy due to tumor mass effect such as bowel obstruction or blood vessel compression\n15. Any medical condition likely to interfere with assessment of safety or efficacy of study treatment\n16. Live vaccine ≤6 weeks prior to planned start of conditioning regimen\n17. Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the conditioning chemotherapy on the fetus or infant.\n18. Females of childbearing potential and males of child fathering potential who are not willing to practice two methods of birth control from the time of consent through 6 months after infusion of the study drug\n19. In the investigator's judgment, the patient is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation.","ALL","18 Years",{"count":18,"type":19},33,"ESTIMATED","INTERVENTIONAL",[22],"PHASE1","To find the highest tolerable dose of JV-213 (a type of autologous CAR T cell therapy) that can be given to patients who have B-cell lymphoma that is relapsed or refractory.",[25,26],"Lymphomas","B-cell Lymphomas",[28],"B-cell lymphoma, CD79b, CAR T cell therapy","RECRUITING","2026-07-28",{"date":32,"type":33},"2026-07-29","ACTUAL",{"date":35,"type":33},"2023-04-14",{"date":37,"type":19},"2028-12-31",{"name":39,"class":40},"M.D. Anderson Cancer Center","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":20,"phases":52,"briefSummary":54,"conditions":55,"keywords":59,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":5},"100647643","phase-2-glory-glofit-gemox-with-liso-cel-for-lymphoma-100647643","NCT07711483","GLORY: Glofit-GemOx With Liso-Cel For Lymphoma","Phase 2 Study of Glofitamab and Gemcitabine and Oxaliplatin (Glofit-GemOx) Bridging to Lisocabtagene Maraleucel in Relapsed\u002FRefractory Aggressive B-cell Lymphomas","GLORY","Inclusion Criteria:\n\n* Histologically confirmed large B-cell NHL including diffuse large B-cell lymphoma (DLBCL), either de novo or transformed from any indolent B-cell lymphoma, DLBCL NOS, primary mediastinal \\[thymic\\] large B-cell lymphoma (PMBCL), high grade B-cell lymphoma NOS, or high grade B-cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangements \\[double\u002Ftriple-hit lymphoma (DHL\u002FTHL)\\]; and grade 3B follicular lymphoma.\n* Relapsed or refractory to 1 prior line of systemic lymphoma therapy if relapse\u002Frefractory within 12 months of initial treatment. Previous therapy must have included a CD20-targeted agent and an anthracycline or alkylating agent. Patients may have received steroids and\u002For polatuzumab-rituximab (without bendamustine), and\u002For radiation therapy for disease control and\u002For palliation \"holding therapy\" between frontline therapy and protocol registration and this will not be considered an additional line of systemic therapy.\n\nOR Relapsed or refractory to 1 prior line of systemic lymphoma therapy at any time after initial treatment if patient is ineligible for a stem cell transplant. Previous therapy must have included a CD20-targeted agent and an anthracycline or alkylating agent. Patients may have received steroids and\u002For polatuzumab-rituximab (without bendamustine), and\u002For radiation therapy for disease control and\u002For palliation \"holding therapy\" between frontline therapy and protocol registration and this will not be considered an additional line of systemic therapy.\n\n* Intent and eligibility to proceed to therapy with lisocabtagene maraleucel\n* Adult patients ≥ 18 years\n* PET-positive measurable disease per Lugano criteria\n* ECOG performance status 0-2\n* Estimated creatinine clearance of ≥30 mL\u002Fmin, calculated using the Cockcroft and Gault equation (if male: \\[140 - Age\\] x Mass \\[kg\\] \u002F \\[72 x creatinine g\u002FdL\\]; multiply by 0.85 if female)\n* Serum Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 3 times the ULN\n* Total Bilirubin ≤1.5 x ULN, unless directly attributable to Gilbert-Meulengracht syndrome and ≤3.0 mg\u002FdL\n* Absolute neutrophil count (ANC) ≥ 1000\u002Fmm3 (G-CSF support allowed if ≥ 24 hours prior to screening lab draw)\n* Hemoglobin ≥8g\u002FdL\n* Platelets ≥ 50,000\u002Fmm3 without transfusion within 7 days\n* Patients with primary CNS lymphoma are not eligible. Patients with secondary CNS involvement by lymphoma are eligible if they otherwise meet all eligibility criteria.\n* The effects of glofitamab, gemcitabine, and oxaliplatin on the developing human fetus are unknown. For this reason and because immunotherapy\u002Fchemotherapy agents are known to be teratogenic, women of child-bearing potential and men must agree to use adequate double-method (each partner) contraception (acceptable means of birth control: condoms (male), condoms (female), intrauterine devices, contraceptive implants, combined hormonal contraceptives (pills, patches, vaginal rings), progestin-only pills, depot medroxyprogesterone acetate (DMPA) injections; 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 and women treated or enrolled on this protocol must also agree to use adequate contraception for the duration of study participation, and 12 months after completion of lisocabtagene maraleucel administration.\n* Willing and able to participate in all required evaluations and procedures in this study protocol.\n* Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information.\n* Ability to understand and agree to forgo donation of blood, organs, sperm, semen, or egg cells after treatment with liso-cel for 12 months.\n\nExclusion Criteria:\n\n* History of prior malignancy that could affect compliance with the protocol or interpretation of results, except for the following: Non-melanoma skin cancers, in situ malignancies, prostate cancer followed with watchful waiting, indolent lymphoma, any previously treated malignancy felt at low risk for recurrence.\n* Evidence of disease (such as severe or uncontrolled systemic diseases) that, in the investigator's opinion, make it undesirable for the patient to participate in the study or that would jeopardize compliance with the protocol\n* Treatment with prior CAR T-cell therapy.\n* Treatment with prior CD20:CD3 bispecific antibody therapy.\n* History of or ongoing confirmed progressive multifocal leukoencephalopathy (PML)\n* Received any investigational drug within 30 days or 5 half-lives (whichever is shorter) before first dose of study drug.\n* Received a live virus vaccination within 28 days of first dose of study drug.\n* Concurrent participation in another therapeutic clinical trial.\n* Current life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator's opinion, could compromise the subject's safety or put the study at risk\n* Previous treatment with gene therapy product or adoptive T cell therapy\n* Allogeneic stem cell transplant within 90 days of leukapheresis\n* Active acute or chronic GVHD requiring immunosuppressive therapy within 6 weeks prior to enrollment\n* Grade 2 or higher peripheral neuropathy\n* HIV infection with positive viral titer by PCR. HIV with negative viral titer by PCR is not an exclusion as long as CD4 count is ≥200 and patient is taking combination antiretroviral therapy.\n* Serologic status reflecting active hepatitis B or C infection\n\n  1. Subjects who are hepatitis B core antibody (HBcAb) positive and who are hepatitis B surface antigen (HBsAg) negative will need to have a negative PCR result before enrollment and must be willing to undergo DNA PCR testing during the study and take anti-HBV therapy with entecavir or equivalent. Those who are HBsAg-positive or hepatitis B PCR positive will be excluded.\n  2. Subjects who are hepatitis C antibody positive will need to have a negative PCR result before enrollment. Those who are hepatitis C PCR positive will be excluded.\n* Any active significant infection (e.g., bacterial, viral, or fungal, including subjects with positive cytomegalovirus \\[CMV\\] DNA polymerase chain reaction \\[PCR\\])\n* Clinically relevant CNS pathology\n* Autoimmune disease requiring chronic systemic corticosteroids at a dose of greater than 10 mg of prednisone daily or an equivalent dose of another corticosteroid\n* Treatment with alemtuzumab, fludarabine, and\u002For bendamustine within 6 months leukapheresis or cladribine within 3 months of leukapheresis\n* Known history of hypersensitivity or anaphylaxis to study drug(s) including active product or excipient components.\n* Breastfeeding or pregnant: Pregnant women are excluded from this study because glofitamab, gemcitabine, oxaliplatin, fludarabine, and cyclophosphamide are agents with the potential for teratogenic or abortifacient effects. Breastfeeding should be discontinued for at least 12 months after last exposure if the mother is treated with these agents.",{"count":51,"type":19},56,[53],"PHASE2","The goal of this clinical trial is to assess the clinical efficacy of bridging therapy with glofitamab\u002Fgemcitabine\u002Foxaliplatin (Glofit-GemOx) followed by lisocabtagene maraleucel (liso-cel) in relapsed\u002Frefractory large B-cell lymphomas. This clinical trial also aims to investigate other efficacy parameters of the combination of Glofit-GemOx plus liso-cel and assess the safety of the combination of Glofit-GemOx bridging plus liso-cel. The main questions it aims to answer are:\n\n* How effective Glofit-GemOx bridged to liso-cel therapy is compared to liso-cel alone?\n* How will Glofit-GemOx bridged to liso-cel therapy affect other factors such as how long treatment effects last, how long patients survive after treatment, re-hospitalization rates, and more?\n* How many patients receiving Glofit-GemOx bridging to liso-cel will experience side effects of differing severities? Participants will receive an obinutuzumab intravenous infusion 3 days prior to undergoing a leukapheresis procedure. 2 days after leukapheresis, participants will receive 1-2 cycles of Glofit-GemOx therapy via intravenous infusion. After completing Glofit-GemOx therapy, participants will receive lymphodepleting chemotherapy via intravenous infusion for 3 consecutive days, 3-5 days prior to then receiving an intravenous infusion of liso-cel.",[56,26,57,58],"Lymphoma","Relapsed\u002FRefractory Large B-cell Lymphoma","Large B-cell Lymphoma",[48,60,61,62,63,64,65],"lymphoma","liso-cel","glofit-gemox","leukapheresis","CAR T-cell","bridging therapy","NOT_YET_RECRUITING","2026-07-14",{"date":69,"type":33},"2026-07-17",{"date":71,"type":19},"2026-10-14",{"date":73,"type":19},"2030-10-01",{"name":75,"class":40},"Massachusetts General Hospital"]