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)
Condition(s) studied
Investigational drug(s) / intervention(s)
AUTO1: Following lymphodepletion with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with anti-CD19 chimeric antigen receptor (CAR) T cells
Study 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).
Eligibility
Primary outcome measure(s)
- Frequency and severity of adverse events (AEs) and serious adverse events (SAEs) — Up to 24 months
- Incidence and duration of severe hypogammaglobulinemia — Up to 24 months
- Proportion of pediatric participants with r/r B ALL at screening who achieve complete remission (CR) within 3 months of obe-cel infusion per Independent Response Review Committee (IRRC) assessment — 3 months
Trial sites (14)
| Facility | City | Region | Status |
|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | Recruiting |
| Lucile Packard Children's Hospital, Stanford University | Palo Alto | California | Recruiting |
| Children's Hospital Colorado | Aurora | Colorado | Recruiting |
| Lurie Children's Hospital | Chicago | Illinois | Recruiting |
| Cincinnati Children's Hospital | Cincinnati | Ohio | Recruiting |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | Recruiting |
| Methodist Children's Hospital | San Antonio | Texas | Recruiting |
| Primary Children's Hospital | Salt Lake City | Utah | Recruiting |
| Seattle Children's Hospital | Seattle | Washington | Recruiting |
| Hospital Vall d'Hebron | Barcelona | Spain | Recruiting |
| Hospital Nino Jesus | Madrid | Spain | Recruiting |
| Great Ormond Street Hospital for Children NHS Foundation Trust | London | United Kingdom | Recruiting |
| Royal Manchester Children's Hospital | Manchester | United Kingdom | Recruiting |
| Great North Children's Hospital | Newcastle upon Tyne | United Kingdom | Recruiting |
More Autolus Limited trials in Spain
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06173518 on ClinicalTrials.gov ↗ ← All trials in Spain