A Study Evaluating the Safety and Efficacy of AUTO1 Obecabtagene Autoleucel in Pediatric Patients With CD19-positive RelapsedRefractory B Cell Acute Lymphoblastic Leukemia or Aggressive Mature B Cell Non-Hodgkin Lymphoma

What this Trial Is About

Researchers are evaluating the safety and effectiveness of autologous T cells engineered with a chimeric antigen receptor CAR targeting CD19 in children under 18 years old with relapsed or refractory B cell acute lymphoblastic leukemia B ALL and aggressive mature B cell Non-Hodgkin lymphoma B NHL. This Phase 1b2, single-arm, open-label, multicenter study aims to better understand the treatments impact in these pediatric patients. The investigational treatment, called AUTO1 Obecabtagene Autoleucel or Obe-cel, is given intravenously after patients undergo lymphodepletion chemotherapy with cyclophosphamide and fludarabine. The study includes sequential periods screening, leukapheresis to collect cells, bridging therapy if needed, lymphodepletion, treatment infusion, evaluation, and follow-up. Safety and side effects will be closely monitored throughout the study. Participants will undergo regular assessments including monitoring for adverse events, blood tests for immune response and remission status, and evaluation of disease markers by an Independent Response Review Committee. Follow-up lasts up to 24 months to track treatment effects, including remission rates and survival outcomes. The study focuses on both safety and treatment response in this pediatric population with relapsed or refractory B cell cancers.

A Study of CD19 Targeted CAR T Cell Therapy in Pediatric Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia (B ALL) and Aggressive Mature B-cell Non-Hodgkin Lymphoma (B NHL)