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.
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.