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Recruiting Phase 1

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)

NCT06173518 · tracked via the Priya Life Science Spain tracker
Phase
Phase 1
Started
2023-11-16
Last updated
2026-10-09

Condition(s) studied

Relapsed or Refractory B Cell Acute Lymphoblastic LeukemiaRelapsed or Refractory B Cell Non-Hodgkin Lymphoma

Investigational drug(s) / intervention(s)

AUTO1 →

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

Sex
ALL
Min age
0 Years
Max age
18 Years
Healthy volunteers
No
INCLUSION CRITERIA: * \< 18 years old at screening * ≥ 6 kg body weight at screening Pediatric patients with r/r B ALL r/r CD19-positive aggressive mature B including the B NHL subtypes: i) diffuse large B cell lymphoma, ii) Burkitt's lymphoma, iii) primary mediastinal large B cell lymphoma, iv) high-grade B cell lymphoma (not otherwise specified). * Karnofsky (age ≥ 10 years) or Lansky (age \< 10 year) performance status score ≥ 50%. * In participants with B ALL, local documentation of CD19 expression on leukemic blasts in the BM, peripheral blood, or cerebrospinal fluid or biopsy done no more than 30 days prior to consent. * Adequate renal, hepatic, pulmonary, and cardiac function. EXCLUSION CRITERIA: * Diagnosis of chronic myelogenous leukemia in lymphoid blast crisis. * History or presence of clinically relevant central nervous system (CNS) pathology unrelated to CNS leukemia. * Presence of active or uncontrolled fungal, bacterial, viral, or other infection requiring systemic antimicrobials for management. * Received prior (\< 3 months before obe cel infusion) stem cell transplantation. * Prior CD19 targeted therapy other than blinatumomab. * Experienced Grade ≥ 3 neurotoxicity following blinatumomab.

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)

FacilityCityRegionStatus
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
Official registry record

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