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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)
Sponsor: Autolus Limited
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).
Official title: A Single-Arm, Open-Label, Multicenter, Phase 1b/2 Study Evaluating the Safety and Efficacy of AUTO1 (Obecabtagene Autoleucel [Obe-cel]) in Pediatric Patients With CD19-positive Relapsed/Refractory (R/R) B Cell Acute Lymphoblastic Leukemia (B ALL) or R/R Aggressive Mature B Cell Non-Hodgkin Lymphoma (B NHL).
Key Details
Gender
All
Age Range
0 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
30
Start Date
2023-11-16
Completion Date
2027-11
Last Updated
2026-03-02
Healthy Volunteers
No
Conditions
Interventions
AUTO1
Following lymphodepletion with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with anti-CD19 chimeric antigen receptor (CAR) T cells
Locations (8)
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Methodist Children's Hospital
San Antonio, Texas, United States
Primary Children's Hospital
Salt Lake City, Utah, 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