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)
Start Date
11/16/2023
Completion Date
11/1/2027
Summary
This is a Phase 1b/2 study to evaluate the safety and efficacy of autologous T cells engineered with a chimeric antigen receptor (CAR) targeting cluster of differentiation (CD)19 in pediatric patients with relapsed or refractory (r/r) B cell acute lymphoblastic leukemia (B ALL) and r/r B cell Non-Hodgkin lymphoma (B NHL).
Detailed Description
This is a single-arm, open-label, multi-center, Phase 1b/2 study to determine the safety and efficacy of obe-cel administered intravenously in pediatric patients \< 18 years old with r/r B ALL and with r/r aggressive mature B NHL. The safety and tolerability of obe cel in pediatric patients will be continually monitored by the Sponsor. Efficacy endpoints will be determined by an Independent Response Review Committee (IRRC). The study will involve consented patients going through the following sequential study periods: screening, leukapheresis, bridging as necessary, lymphodepletion, treatment evaluation, and follow-up.
Eligibility Criteria
Age Range: No minimum to 18 years
Interventions
AUTO1
Conditions
Locations
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
United States
Methodist Children's Hospital
San Antonio, Texas 78229
United States
Primary Children's Hospital
Salt Lake City, Utah 84113
United States
Hospital Vall d'Hebron
Barcelona,
Spain
Hospital Nino Jesus
Madrid,
Spain
Great Ormond Street Hospital for Children NHS Foundation Trust
London,
United Kingdom
Royal Manchester Children's Hospital
Manchester,
United Kingdom
Great North Children's Hospital
Newcastle upon Tyne,
United Kingdom