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RECRUITING Phase 1 ClinicalTrials.gov

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 • ClinicalTrials.gov ID: NCT06173518

Registry updated: 2026-10-09
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Description

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).

Interventions

  • AUTO1 (Biological)
    Following lymphodepletion with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with anti-CD19 chimeric antigen receptor (CAR) T cells

Eligibility criteria

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.

Conditions

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

Locations

  • Children's Hospital Los Angeles — Los Angeles, California, United States
  • Lucile Packard Children's Hospital, Stanford University — Palo Alto, California, United States
  • Children's Hospital Colorado — Aurora, Colorado, United States
  • Lurie Children's Hospital — Chicago, Illinois, United States
  • Cincinnati Children's Hospital — Cincinnati, Ohio, United States
  • 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
  • Seattle Children's Hospital — Seattle, Washington, 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
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record