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NCT06173518PHASE1Recruiting

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)

Autolus Limited

Start Date

11/16/2023

Completion Date

11/1/2027

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).

Detailed Description

This is a single-arm, open-label, multi-center, Phase 1b/2 study to determine the safety and efficacy of obe-cel administered intravenously in pediatric patients \< 18 years old with r/r B ALL and with r/r aggressive mature B NHL. The safety and tolerability of obe cel in pediatric patients will be continually monitored by the Sponsor. Efficacy endpoints will be determined by an Independent Response Review Committee (IRRC). The study will involve consented patients going through the following sequential study periods: screening, leukapheresis, bridging as necessary, lymphodepletion, treatment evaluation, and follow-up.

Eligibility Criteria

Age Range: No minimum to 18 years

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.

Interventions

BIOLOGICAL

AUTO1

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Conditions

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

Locations

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania 19104

United States

Methodist Children's Hospital

San Antonio, Texas 78229

United States

Primary Children's Hospital

Salt Lake City, Utah 84113

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