Early Study of JY231 Injection for Safety and Effectiveness in Treating Relapsed or Resistant B-Cell Lymphoma and Leukemia

What this Trial Is About

Researchers are evaluating the safety, tolerability, and initial effectiveness of JY231 injection, an in vivo CAR-T cell therapy, for patients with relapsed or refractory B cell lymphoma or leukemia. This early exploratory, open-label, single-arm clinical study targets individuals aged 12 to 75 years who have specific types of B-cell malignancies that have not responded to prior treatments. The goal is to better understand how this therapy affects the disease and patient safety. Participants will undergo leukapheresis to collect cells, followed by 3 to 5 days of lymphodepleting chemotherapy with fludarabine and cyclophosphamide. After this preparation, they will receive an intravenous infusion of JY231, which produces CAR-T cells directly in the body. Following infusion, patients will be hospitalized for one month for close observation and monitoring. Throughout the study, participants will be closely monitored for adverse events and treatment tolerance up to two years. Safety assessments and disease control will be evaluated at multiple time points, including days 28, months 2, 3, 6, 12, 18, and 24. Researchers will also measure the maximal tolerated dose and objective response rate within three months post-infusion. This comprehensive follow-up ensures a detailed understanding of therapy effects and patient well-being.

JY231(JY231) Injection for the Treatment of Relapsed/Refractory B Cell Lymphoma/ Leukemia