Study of B019 Injection to Assess Safety and Early Effectiveness in Children and Young Adults with Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia

What this Trial Is About

Researchers are evaluating the safety, tolerability, and early effects of B019 injection in individuals aged 3 to 25 years with relapsed or refractory B-cell acute lymphoblastic leukemia. This phase 1 clinical study is sponsored by Shanghai Pharmaceutical Group Biological Therapy Technology Co., Ltd. and aims to gather important information about the treatments impact on this serious blood cancer. Participants receive B019 through an intravenous infusion at doses ranging from 1.0 x 106 to 10.0 x 106 CAR T cells per kilogram. The study focuses on monitoring any treatment-related side effects and serious adverse events over about two years. The research team also examines how the body processes the treatment and measures overall survival and response rates within this period. During the trial, participants will be observed for up to two years to track safety and treatment outcomes. Researchers will collect data on adverse events, overall response to the therapy within three months, and survival over two years. The study includes regular health assessments and laboratory tests to monitor organ function and treatment effects, ensuring careful safety follow-up throughout the study duration.

A Clinical Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of B019 Injection in Subjects With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia.