Phase 12b Study of Autologous Humanized CD19 CAR T-Cell Therapy Made Using the CliniMACS Prodigy Platform to Treat Children and Young Adults with B Cell Acute Lymphoblastic Leukemia

What this Trial Is About

Researchers are evaluating a new manufacturing process using the CliniMACS Prodigy platform to produce humanized CD19-directed CAR T cells huCART19 for children and young adults with B cell Acute Lymphoblastic Leukemia B-ALL, including those with relapsed or refractory disease. This trial aims to determine the safety and effectiveness of this second-generation, semi-automated manufacturing process, which may reduce the time and resources needed compared to the first-generation method. The study includes a phase 1 dose escalation portion using a 33 design to find the recommended dose of huCART19 cells for patients previously treated with CD19-directed CAR T cells. Two dose escalations are planned. If safe doses are identified, a phase 2b dose expansion phase will open, enrolling participants in two groups those who have not received CAR T-cell therapy before and those with prior CD19-directed CAR T cell treatment. Participants receive autologous T cells engineered to target CD19 on leukemia cells. Participants will be closely monitored for safety and treatment response over a 5-year period. Researchers will assess safety, efficacy, manufacturing feasibility, and anti-tumor response through various tests and evaluations. Key outcomes include remission rates, CAR T cell persistence, event-free and overall survival. The study involves regular clinical assessments and laboratory monitoring to track these outcomes throughout the trial duration.

Autologous HuCART19 T Cells Manufactured Using the CliniMACS Prodigy Platform for Pediatric B-ALL (huCART19 Prodigy)