Phase II Study of SenlB19 CAR-T Cells for Treating Relapsed or Refractory CD19-Positive B-Cell Acute Lymphoblastic Leukemia in Children and Young Adults

What this Trial Is About

Researchers are evaluating the efficacy and safety of S1904, an autologous anti-CD19 CAR-T cell therapy, in children and young adults aged 3 to 25 years with relapsed or refractory CD19-positive B-cell acute lymphoblastic leukemia B-ALL. This Phase II, open-label, multicenter study aims to assess the treatment effects and further characterize safety in this patient group. Participants will receive a single intravenous infusion of S1904 CAR-T cells at a dose of 1 million cells per kilogram of body weight. The treatment involves using the patients own modified immune cells to target CD19-positive leukemia cells. There are no placebo or comparator groups, and the study is designed to monitor the response to this experimental therapy. During the study, participants will undergo evaluations including bone marrow biopsies and flow cytometry to confirm disease status and CD19 expression. Researchers will measure the objective response rate three months after infusion to assess effectiveness. Safety and treatment tolerability will also be closely monitored throughout the trial, which is expected to continue until the end of 2028.

Assessment of Senl_B19 CAR-T Cells in Relapsed/Refractory CD19+ B-ALL