RecruitingPhase 1NCT06173518

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)

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).


Sponsor

Autolus Limited

Enrollment

30 participants

Start Date

Nov 16, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 0 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a personalized cell therapy called CAR T cell therapy — where a patient's own immune cells are reprogrammed to attack cancer — for children with relapsed or treatment-resistant B cell leukemia (B-ALL) or aggressive B cell lymphoma (B-NHL). **You may be eligible if...** - You are under 18 years old and weigh at least 6 kg - You have been diagnosed with relapsed or refractory B cell acute lymphoblastic leukemia (B-ALL) or aggressive B cell lymphoma (such as diffuse large B cell lymphoma or Burkitt's lymphoma) - Your cancer cells test positive for the CD19 protein - You have adequate kidney, liver, lung, and heart function **You may NOT be eligible if...** - You have chronic myelogenous leukemia in blast crisis - You have active, uncontrolled infections - You have significant central nervous system disease unrelated to leukemia - You have previously received certain CAR T cell therapies targeting CD19 Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAUTO1

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

View Full Details on ClinicalTrials.gov

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NCT06173518


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