Early Study of JY231 Injection Safety and Effectiveness for Treating Relapsed or Refractory B-cell Lymphoma and Leukemia

What this Trial Is About

Researchers are evaluating the safety, tolerability, and initial effectiveness of JY231 injection in patients with relapsed or refractory B-cell lymphoma or leukemia. This early exploratory clinical study focuses on people whose cancer has returned or not responded to previous treatments. The study is designed to explore an in vivo CAR-T cell therapy approach for these conditions. The study includes two pretreatment options lymphodepletion and non-lymphodepletion regimens. In the lymphodepletion regimen, patients undergo leukapheresis followed by 3 to 5 days of chemotherapy with fludarabine and cyclophosphamide, then receive an intravenous infusion of JY231 and their own peripheral blood mononuclear cells PBMCs. In the non-lymphodepletion regimen, patients receive a direct intravenous injection of JY231. After treatment, patients are monitored for safety and efficacy up to three months, with a follow-up of at least 24 months for those who achieve sustained remission. Participants will receive intravenous JY231 infusion, which produces CAR-T cells inside the body. Throughout the study, safety and response to treatment will be assessed at multiple time points up to 24 months, including checking for adverse events and the maximum tolerated dose. Researchers will use imaging, blood tests, and clinical evaluations to monitor disease control and organ function. Participants are expected to have good organ function and meet specific health criteria before joining, and they will be followed closely during and after treatment to assess outcomes and safety.

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