Study of Talikabtagene Autoleucel NexCAR19 CAR-T Cell Therapy in Adults With Relapsed or Refractory B-Cell Leukemia and Lymphoma Phase 2-3 Open-Label Multicenter Trial

What this Trial Is About

Researchers are evaluating Talikabtagene Autoleucel, an anti-CD19 CAR-T cell therapy, in adults with relapsed or refractory B-cell malignancies such as B-cell Acute Lymphoblastic Leukemia B-ALL and Non-Hodgkin Lymphoma. This national, open-label, multicenter Phase 2-3 trial supported by the Turkish Health Institutes aims to assess the treatments overall response rate 28 days after infusion and to monitor its safety profile. Secondary goals include studying complete remission, survival rates, and treatment-related side effects like cytokine release syndrome and neurotoxicity. The treatment involves collecting the patients own T cells through leukapheresis, modifying them in the lab to target CD19 on cancer cells, and then reinfusing them after administering lymphodepleting chemotherapy if needed. Patients receive a single infusion of the CAR-T cells. The study includes short-term monitoring especially during the first 10 days post-infusion for side effects, followed by long-term follow-up lasting up to 30 months. Participants will undergo regular assessments including imaging scans, bone marrow evaluation, immune function tests, and laboratory tests to track response and CAR-T cell persistence. Safety monitoring includes watching for adverse events and immune-related effects over time. The overall study duration includes about 6 months for recruitment, 3 months for treatment and early follow-up, and 21 months for long-term monitoring to gather comprehensive data on outcomes and safety.

NexCAR19 (Talikabtagene Autoleucel) in Relapsed/Refractory B-Cell Malignancies (NexCAR19)