Phase III Study of IL-7IL-15 Expanded CAR-2019-T Cells for Adults With Relapsed or Refractory B-Cell Malignancies Including NHL, CLL, and CNS Lymphoma

What this Trial Is About

Researchers are evaluating the safety and effectiveness of CAR-2019-T cells expanded with Interleukin-7 and Interleukin-15 IL-7IL-15 in adults with relapsed or refractory B cell malignancies, including various types of non-Hodgkin lymphoma, chronic lymphocytic leukemia CLL, and central nervous system CNS lymphoma. This Phase 12 study also examines how flexible manufacturing of these CAR-T cells affects treatment feasibility and outcomes. The trial includes several groups to test different manufacturing processes and patient populations. Participants receive a fixed dose of 2.5 million CAR-2019-T cells per kilogram of body weight, expanded with IL-7IL-15. The study has multiple arms, including flexible manufacturing with 8- or 12-day production times, a fixed 12-day manufacturing process, and a group with cryopreserved CAR-T cells before infusion. Separate groups also focus on CLL and CNS lymphoma patients. The Phase 2 portion measures the complete response rate at three months in mantle cell lymphoma MCL patients. During the study, patients undergo detailed assessments including brain MRI and lumbar puncture when needed, disease measurement through scans or biopsies, and blood tests to monitor safety and treatment effects. Researchers track adverse events within the first 28 days after infusion as a primary outcome. Participants are monitored for safety, treatment response, and long-term follow-up. The total study duration and specific procedures depend on the study arm and patient condition.

CAR-20/19-T Cells in Patients With Relapsed Refractory B Cell Malignancies