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)

Plain-language summary

This Phase 1b/2 study evaluates the safety and efficacy of autologous T cells engineered with a CD19-targeting chimeric antigen receptor (AUTO1, obecabtagene autoleucel / obe-cel) in children with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) and relapsed or refractory B-cell non-Hodgkin lymphoma (B-NHL). Eligible participants are under 18 years old at screening, weigh at least 6 kg, and have relapsed/refractory B-ALL or CD19-positive aggressive mature B-NHL subtypes such as diffuse large B-cell lymphoma, Burkitt's lymphoma or primary mediastinal large B-cell lymphoma.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 1

Status

Recruiting

Sponsor

Autolus Limited

Intervention

AUTO1 (Obecabtagene autoleucel (obe-cel))

Start date

11/16/2023

Estimated completion

11/1/2027

Countries

United States, Spain, United Kingdom

Locations

• Philadelphia, United States
• San Antonio, United States
• Salt Lake City, United States
• Barcelona, Spain
• Madrid, Spain
• London, United Kingdom
• Manchester, United Kingdom
• Newcastle upon Tyne, United Kingdom

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.