JY231 Injection for the Treatment of B-cell Malignancies Early Exploratory Clinical Studies on Safety, Tolerability, and Initial Efficacy

What this Trial Is About

Researchers are evaluating the safety, tolerability, and initial effectiveness of JY231 injection, an in vivo Chimeric Antigen Receptor T-Cell (CAR-T cell) therapy, for patients with relapsed or refractory B-cell Malignancies. This early exploratory, single-center, single-arm clinical study focuses on patients who have limited treatment options due to the return or persistence of their disease. The study aims to understand how well the treatment works and how safe it is for this patient population. Participants will receive a single intravenous infusion of the JY231 injection upon joining the study. After the infusion, they will be hospitalized for one month for close observation to monitor safety and any side effects. Following this initial period, participants will be followed for up to two years to track the control of their disease and to evaluate longer-term effects of the therapy. Throughout the study, researchers will conduct regular assessments including monitoring for adverse events up to 28 days after infusion and at multiple time points over two years. They will also evaluate the response to treatment at these intervals. Participants will undergo physical exams and tests to assess organ function and disease status. The study duration from treatment to final follow-up can last up to two years, with ongoing safety and efficacy evaluations.

JY231(JY231) Injection for the Treatment of R/R B-cell Malignancies