Early Phase Study of JY231 Injection 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, an in vivo CAR-T cell therapy, in patients with relapsed or refractory B-cell lymphoma or leukemia. This early exploratory clinical study focuses on patients whose cancer has returned or is resistant to previous treatments, aiming to better understand how JY231 works in this population. Participants will undergo leukapheresis to collect cells, followed by 3 to 5 days of chemotherapy with fludarabine and cyclophosphamide to prepare the body. Then, they will receive an intravenous infusion of the JY231 injection, which produces CAR-T cells in the body to target cancer cells. After infusion, patients will be hospitalized for one month for monitoring and then followed for up to two years to assess disease control and safety. During the study, patients will have regular safety checks and evaluations of their response to treatment at multiple time points up to 24 months. Researchers will monitor adverse events and determine the maximal tolerated dose within 28 days after infusion. The main outcome is safety, while treatment effectiveness will also be assessed through response rates within three months. Participants will be closely observed to understand how well the therapy controls their disease and to track any side effects over time.

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