Study of JY231 Injection to Treat Adults with Relapsed or Refractory B Cell Lymphoma or Leukemia Evaluating Safety, Tolerability, and Effectiveness

What this Trial Is About

Researchers are studying the safety, tolerability, and initial effectiveness of JY231 injection in patients with relapsed or refractory B cell lymphoma or leukemia. This early exploratory clinical trial focuses on patients whose cancer has returned or not responded to previous treatments, aiming to evaluate a new in vivo CAR-T cell therapy approach. Participants will undergo leukapheresis to collect cells, followed by 3 to 5 days of lymphodepleting chemotherapy with fludarabine and cyclophosphamide. Then, they will receive an intravenous infusion of JY231, which is designed to produce CAR-T cells inside the body. The study starts with a set starting dose and may escalate to higher doses to assess safety. During the study, participants will be monitored for safety and treatment response for up to 24 months. Researchers will track adverse events at multiple time points and evaluate the maximum tolerated dose within 28 days after infusion. They will also measure the objective response rate up to 3 months after treatment. Participants will undergo regular assessments, including imaging and laboratory tests, to determine disease control and overall health throughout the study period.

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