Safety and Effects of RD06-03 CART Cell Injection in Patients With Relapsed or Refractory B-lymphoblastic Leukemia

What this Trial Is About

Researchers are evaluating the safety and effectiveness of RD06-03 CART cell injection in patients aged 3 to 70 years with relapsed or refractory acute B-cell lymphoblastic leukemia (B-ALL). The study includes patients who have relapsed after various treatments including chemotherapy or stem cell transplantation, as well as those who have not achieved remission after standard therapies. The trial also considers patients with Philadelphia chromosome-positive ALL who meet specific treatment history criteria. This early phase 1 trial aims to carefully assess dose-limiting toxicities and treatment responses in this patient population. Participants receive RD06-03 cell injections at one of three escalating dose levels: 1×10^5, 3×10^5, or 5×10^5 CAR+ T Cells per kilogram of body weight administered via a single intravenous injection. The trial first completes the dose escalation phase with close monitoring for toxicities, followed by a dose-limiting toxicity observation period. Afterwards, an efficacy exploration phase lasting up to one year begins. Depending on safety and treatment response, some dose groups may be expanded to include up to 12 patients without further dose-limiting toxicity evaluation. Throughout the study, patients undergo bone marrow exams to confirm diagnosis and assess disease markers such as CD19 expression. Organ function tests, blood tests, and heart and lung function are monitored to ensure safety. The primary outcome measure is the occurrence of dose-limiting toxicities up to two years after treatment. The study also requires contraception use for fertile participants during and after treatment. Overall participation may last over a year as safety and effectiveness are closely followed and evaluated.

The Safety and Efficacy of RD06-03 CART Cell Injection in Patients With R/R Acute B-lymphoblastic Leukemia