[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"relapsedrefractory-non-hodgkin-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:relapsedrefractory-non-hodgkin-lymphoma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,83],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100523047","phase-1-a-study-to-assess-bms-986458-alone-and-in-combination-with-anti-lymphoma-agents-in-relapsedrefractory-non-hodgkin-lymphomas-100523047",false,"NCT06090539","A Study to Assess BMS-986458 Alone and in Combination With Anti-lymphoma Agents in Relapsed\u002FRefractory Non-Hodgkin Lymphomas","A Phase 1\u002F2, Multi-Center, Open-Label, Dose-Finding Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of BMS-986458, Alone and in Combination With Anti-lymphoma Agents in Participants With Relapsed\u002FRefractory Non-Hodgkin Lymphomas (R\u002FR NHL)","Inclusion Criteria:\n\n* Participants ≥ 18 years of age with frontline or R\u002FR NHL.\n* Participant must have measurable disease (defined by at least one FDG-avid lesion for FDG-avid disease and one bi-dimensionally measurable disease on cross sectional imaging by computed tomography or magnetic resonance imaging with at least one lesion \\> 1.5 cm in the transverse diameter).\n* Participants must accept and follow pregnancy prevention plan.\n\nExclusion Criteria:\n\n* Participants must not have an Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2.\n* Participants with an inability to comply with listed restrictions, precautions and prohibited treatments.\n* Participants must not have prior CAR-T, or radiotherapy ≤ 4 weeks, systemic anticancer treatment ≤ 5 half-lives or 4 weeks, allogeneic SCT ≤ 6 months (only applicable to BMS-986458 single agent or rituximab combination cohorts), or autologous SCT ≤ 3 months prior to study intervention initiation.\n* In BMS-986458 + T-cell engager combination cohorts: Participants must not have prior alloSCT or solid organ transplantation, history of confirmed progressive multifocal leukoencephalopathy (PML); known or suspected history of hemophagocytic lymphohistiocytosis (HLH); known or suspected chronic active Epstein-Barr (EBV) infection.\n* Participants must not have any condition, including significant acute or chronic medical illness, active or uncontrolled infection, or the presence of laboratory abnormalities, that places participants at unacceptable risk if participating in this study.\n* Participants must not have known or suspected central nervous system involvement.\n* Other protocol-defined Inclusion\u002FExclusion criteria apply.","ALL","18 Years",{"count":19,"type":20},460,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","The purpose of this study is to evaluate the safety, tolerability, drug levels, and preliminary biological and clinical activity of BMS-986458, a bifunctional cereblon-dependent ligand-directed degrader of B-cell lymphoma 6 (BCL6), as a single agent and in combination with anti-lymphoma agents in participants with relapsed\u002Frefractory non-Hodgkin Lymphoma.",[27],"Relapsed\u002FRefractory Non-Hodgkin Lymphoma","RECRUITING","2026-06-18",{"date":31,"type":32},"2026-06-22","ACTUAL",{"date":34,"type":32},"2023-12-29",{"date":36,"type":20},"2028-10-28",{"name":38,"class":39},"Bristol-Myers Squibb","INDUSTRY",67,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":53,"conditions":54,"keywords":59,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":82},"100631548","phase-2-nexcar19-talikabtagene-autoleucel-in-relapsedrefractory-b-cell-malignancies-nexcar19-100631548","NCT07502118","NexCAR19 (Talikabtagene Autoleucel) in Relapsed\u002FRefractory B-Cell Malignancies (NexCAR19)","An Open-Label, Multicenter Phase 2-3 Clinical Study of Anti-CD19 Chimeric Antigen Receptor T Cells (Talikabtagene Autoleucel) in Patients With Relapsed\u002FRefractory B-Cell Malignancies (NexCAR19)","NexCAR19","Inclusion Criteria\n\n1. All participants must meet Inclusion Criteria 1-13.\n\n   Additionally:\n2. High-grade lymphoma subjects must meet Criteria 14-18.\n3. Other B-cell lymphoma subjects must meet Criteria 19-24.\n4. B-ALL subjects must meet Criteria 25-29.\n\nGeneral Inclusion Criteria (Applicable to All Cohorts)\n\n1. Age ≥18 years.\n2. Patients approved for leukapheresis by the CAR-T cell treatment council.\n3. ECOG performance status \\\u003C2.\n4. Life expectancy ≥12 weeks.\n5. Renal Function: Estimated creatinine clearance ≥60 mL\u002Fmin (Cockcroft-Gault) → fludarabine\u002Fcyclophosphamide lymphodepletion.\n\n   In lymphoma cohort patients with creatinine clearance 30-60 mL\u002Fmin, bendamustine may be used as an alternative due to cumulative fludarabine toxicity and neurotoxicity risk.\n6. Liver Function:\n\n   1. ALT and AST ≤3 × ULN unless attributable to underlying malignancy.\n   2. Total bilirubin ≤2 × ULN except in Gilbert syndrome, isolated unconjugated hyperbilirubinemia, or if attributable to underlying malignancy.\n7. Hemodynamically stable with LVEF ≥45% (confirmed by echocardiography or MUGA scan).\n8. Baseline oxygen saturation \\>92% on room air.\n9. ANC ≥500\u002FµL (may be waived if cytopenia due to underlying malignancy at investigator discretion).\n10. Platelet count ≥50,000\u002FµL (may be waived if cytopenia due to underlying malignancy at investigator discretion).\n11. Negative serum or urine pregnancy test (within 24 hours prior to conditioning therapy) in women of childbearing potential; also negative prior to leukapheresis.\n12. Sexually active patients (women of childbearing potential and all men) must use highly effective contraception for ≥12 months after CAR-T infusion.\n13. Written informed consent provided.\n\n    High-Grade Lymphoma - Additional Inclusion Criteria (14-18)\n14. Histologically confirmed previously treated:\n\n    1. Diffuse large B-cell lymphoma (DLBCL)\n    2. Primary mediastinal B-cell lymphoma\n    3. Transformed indolent B-cell lymphoma\n    4. Follicular lymphoma Grade 3B\n    5. High-grade B-cell lymphoma\n15. Chemotherapy-refractory disease defined as:\n\n    1. Primary refractory disease\n    2. Best response to last chemotherapy = PD or SD (biopsy confirmed)\n    3. Progression\u002Frelapse ≤12 months after autologous SCT\n    4. Relapse ≤12 months after first-line CR (biopsy confirmed)\n    5. Relapse beyond 12 months if auto-SCT not feasible\n16. Not eligible for or unwilling to undergo autologous SCT.\n17. Must have received anti-CD20 monoclonal antibody and anthracycline-containing regimen. Transformed lymphoma subjects must have received ≥2 prior systemic lines.\n18. Measurable disease per International Working Group (IWG) criteria.\n\n    Other B-Cell Lymphomas - Additional Inclusion Criteria (19-24)\n19. Histologically confirmed:\n\n    1. Mantle Cell Lymphoma (Cyclin D1 overexpression or t(11;14))\n    2. Follicular Lymphoma Grade I-IIIA\n    3. Marginal Zone Lymphoma\n20. Relapsed or refractory disease:\n\n    1. MCL: ≤5 prior regimens including:\n\n       * Anthracycline or bendamustine\n       * Anti-CD20 antibody\n       * BTK inhibitor (ibrutinib or acalabrutinib; intolerance allowed)\n    2. FL\u002FMZL: Progression after ≥2 combination chemoimmunotherapy regimens (single-agent CD20 or splenectomy not counted).\n21. Radiologically measurable disease at screening\n\n    1. per revised IWG (Cheson 2007): ≥1 measurable lesion\n    2. Previously irradiated lesions measurable only if progression documented\n    3. If only nodal disease: ≥1 node ≥2 cm\n22. No known active CNS lymphoma involvement.\n23. Prior therapy toxicities resolved to ≤Grade 1 (except alopecia).\n24. Prior autologous HCT, POD24 status, and prior PI3K inhibitor therapy allowed.\n\n    B-Cell Acute Lymphoblastic Leukemia (B-ALL) - Additional Inclusion Criteria (25-29)\n25. Relapsed\u002FRefractory B-ALL meeting one of:\n\n    1. Primary refractory disease\n    2. First relapse ≤12 months\n    3. ≥2 prior systemic lines\n    4. Post-allogeneic SCT relapse (≥100 days post-transplant; off immunosuppression ≥4 weeks)\n    5. Ph+ disease:\n\n       * TKI intolerance\n       * Relapsed\u002Frefractory after ≥2 TKIs\n       * No alternative TKI option\n    6. Ineligible for allogeneic SCT due to\n\n       * comorbidity,\n       * conditioning contraindication,\n       * no donor,\n       * prior SCT,\n       * or refusal (documented).\n26. Morphological bone marrow disease.\n27. CD19 tumor expression documented within 3 months (BM or PB by flow cytometry).\n28. Absolute lymphocyte count ≥100\u002FµL.\n29. ≥3 half-lives elapsed since prior immune checkpoint inhibitor or stimulatory therapy\n\nExclusion Criteria\n\n1. All participants must meet Exclusion Criteria 1-14.\n\n   Additionally:\n2. High-grade lymphoma: 15-22\n3. Low-grade lymphoma: 23-24\n4. B-ALL: 25\n\nGeneral Exclusion Criteria (All Cohorts)\n\n1. Uncontrolled life-threatening infection (e.g., positive blood culture ≤72h before infusion).\n2. HIV positive.\n3. Active HBV replication or active HCV (RNA positive).\n4. Unstable angina or MI within 6 months.\n5. Uncontrolled cardiac arrhythmia.\n6. Concurrent malignancy except adequately treated non-melanoma skin cancer, in situ carcinoma (≥3 years disease-free), or completely resected malignancy in CR ≥3 years.\n7. Pregnant or breastfeeding.\n8. Hypersensitivity to CAR-T product excipients.\n9. Active autoimmune\u002Finflammatory neurologic disorders.\n10. Primary immunodeficiency.\n11. Short-acting leukemia\u002Flymphoma therapies must be stopped \\>72h before leukapheresis and infusion.\n12. Burkitt lymphoma\u002Fleukemia.\n13. Steroids must be discontinued \\>72h prior (\\\u003C12 mg\u002Fm²\u002Fday hydrocortisone equivalent allowed).\n14. Investigator deems subject unable to comply.\n\n    High-Grade Lymphoma - Additional Exclusion (15-22)\n15. Active CNS involvement.\n16. Prior allogeneic HSCT.\n17. Systemic immunosuppressives not discontinued ≥1 weeks before leukapheresis\u002Finfusion.\n18. Anti-proliferative therapy not stopped ≥1 weeks prior.\n19. Cytotoxic drugs not stopped ≥1 week prior.\n20. A minimum interval of ≥4 weeks is required between donor lymphocyte infusion (DLI) and leukapheresis, and ≥4 weeks between DLI and CAR-T cell infusion. This requirement applies to prior antibody-based therapies, including anti-CD20, anti-CD22, anti-CD79a, and similar agents.\n21. CNS prophylaxis not stopped \\>1 week prior.\n22. Radiation not stopped ≥2 days before leukapheresis and ≥1 week before infusion.\n\n    Low-Grade Lymphoma - Additional Exclusion (23-24)\n23. Live vaccine ≤6 weeks before conditioning.\n24. Tumor mass effect requiring urgent treatment.\n\n    B-ALL - Additional Exclusion (25)\n25. Acute graft-versus-host disease (GVHD) of Grade II-IV according to the Glucksberg criteria or Grade B-D according to the IBMTR index; or acute or chronic GVHD requiring systemic treatment within 4 weeks prior to enrollment.",{"count":50,"type":20},40,[24,52],"PHASE3","The NexCAR19 study is a national, open-label, multicenter Phase 2-3 clinical trial designed to evaluate the efficacy and safety of the anti-CD19 chimeric antigen receptor (CAR) T-cell product, Talikabtagene Autoleucel, in patients with relapsed\u002Frefractory B-cell malignancies, including B-cell Acute Lymphoblastic Leukemia (B-ALL) and Non-Hodgkin Lymphoma. The study is supported by the Presidency of Turkish Health Institutes (TÜSEB) and will be conducted at four centers.\n\nThis therapy is based on collecting the patient's own T cells, genetically modifying them in a laboratory to recognize the CD19 antigen, and reinfusing them into the patient. The goal is to target leukemia or lymphoma cells and achieve disease control.\n\nThe primary objective is to assess the overall response rate at Day 28 after infusion and to evaluate the safety profile of the treatment. Secondary objectives include assessment of complete response rate, duration of response, overall survival, and progression-free survival, as well as the frequency and severity of cytokine release syndrome (CRS), neurotoxicity (ICANS), and other treatment-related adverse events. In addition, the in vivo persistence and immunological effects of CAR-T cells will be evaluated.\n\nEligible patients must be 18 years of age or older, have an adequate performance status, sufficient organ function, and meet disease-specific eligibility criteria. Key exclusion criteria include active severe infection, uncontrolled cardiac disease, active central nervous system involvement (where applicable), HIV or active hepatitis infection, pregnancy, and severe immunodeficiency.\n\nThe treatment process includes leukapheresis for cell collection, administration of lymphodepleting chemotherapy if required, followed by a single infusion of CAR-T cells. Patients will be closely monitored after infusion, particularly during the early period, and both early and late adverse events, as well as treatment response, will be regularly assessed.\n\nA total of 40 patients are planned to be enrolled. The overall clinical follow-up period, including short- and long-term monitoring, is expected to last approximately 30 months. Data will be analyzed using appropriate statistical methods.",[55,27,56,57,58],"Relapsed\u002FRefractory B-cell Acute Lymphoblastic Leukemia (B-ALL)","Diffuse Large B-Cell Lymphoma (DLBCL)","High-grade B-cell Lymphoma (HGBCL)","Follicular Lymphoma ( FL)",[60,61,62,63,64,65,66,67,68,69,70,71],"Relapsed\u002FRefractory B-Cell Malignancies","B-Cell Acute Lymphoblastic Leukemia (B-ALL)","Non-Hodgkin Lymphoma","High-Grade Lymphoma","Low-Grade Lymphoma","CD19","CAR-T Cell Therapy","Talikabtagene Autoleucel","Autologous T Cells","Adoptive Cell Therapy","Cytokine Release Syndrome (CRS)","ICANS","2026-03-24",{"date":74,"type":32},"2026-03-30",{"date":76,"type":32},"2025-09-11",{"date":78,"type":20},"2030-01-01",{"name":80,"class":81},"Health Institutes of Turkey","OTHER_GOV",4,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":16,"minAge":90,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":21,"phases":93,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":82},"100506873","phase-1-gic-102-intravenous-allogeneic-nk-cells-in-subjects-with-advanced-solid-cancers-and-rr-hematologic-malignancies-100506873","NCT05880043","GIC-102, Intravenous Allogeneic NK Cells, in Subjects With Advanced Solid Cancers and R\u002FR Hematologic Malignancies","An Open-label, Multi-center, Dose-escalation and Expansion, Phase 1\u002F2a Study to Evaluate the Safety, Tolerability, PK\u002FPD, and Preliminary Anti-tumor Activity of GIC-102 Monotherapy in Patients With Advanced Solid Tumors, R\u002FR Non-Hodgkin Lymphoma, and Multiple Myeloma","Inclusion criteria:\n\n1. At least 19 years of age\n2. Advanced solid tumors, relapsed\u002Frefractory non-hodgkin lymphoma, and multiple myeloma\n3. At least one measurable or evaluable lesion\n4. Eastern Cooperative Oncology Group performance status 0 or 1\n5. A life expectancy of 12 weeks or more\n6. Acceptable hematological function, kidney, and liver function\n7. Subjects who sign on an informed consent form willingly\n\nExclusion Criteria:\n\n1. Clinically significant cardiovascular disease within 24 weeks\n2. Primary malignant tumor other than the indications for this study\n3. The following diseases\n\n   1. Severe infection or other uncontrolled active infectious disease requiring administration of systemic antibiotics or antivirals within 4 weeks\n   2. The New York Heart Association class III\u002FIV\n   3. Active hepatitis B virus or hepatitis C virus infection\n   4. Human immunodeficiency virus positive\n   5. Clinically significant symptoms or uncontrolled central nervous system metastasis\n4. Previously been diagnosed with immunodeficiency or need systemic corticosteroids or other systemic immunosuppressants within 2 weeks or require administration of systemic immunosuppressants during the study\n5. Received chemotherapy other than pre-conditioning within 4 weeks\n6. Underwent major surgery within 4 weeks prior or minor surgery within 2 weeks\n7. Hypersensitivity reactions to the study drug or excipients\n8. Hypersensitivity to cyclophosphamide or fludarabine\n9. Have received allogeneic cell therapy within 6 months or autologous stem cell therapy within 4 weeks\n10. Have previously received an allogeneic tissue\u002Fsolid organ transplant\n11. Have administered other investigational drug or applied other investigational medical device within 4 weeks\n12. Pregnant or lactating female subjects\n13. Male subjects who did not agree to use contraception or to maintain abstinence","19 Years",{"count":92,"type":20},50,[23,24],"This is a first-in-human trial to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor effects of GIC-102 in patients with advanced solid tumors, relapsed\u002Frefractory non-hodgkin lymphoma, and multiple myeloma.",[96,27,97],"Advanced Solid Tumors","Relapsed\u002FRefractory Multiple Myeloma","2024-07-04",{"date":100,"type":32},"2024-07-09",{"date":102,"type":32},"2023-04-28",{"date":104,"type":20},"2026-06-30",{"name":106,"class":39},"GI Cell, Inc."]