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).
< 18 years old at screening
≥ 6 kg body weight at screening
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.
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.
Single group
AUTO1
Biological/VaccineFollowing lymphodepletion with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with anti-CD19 chimeric antigen receptor (CAR) T cells
Frequency and severity of adverse events (AEs) and serious adverse events (SAEs)
Incidence and duration of severe hypogammaglobulinemia
Proportion of pediatric participants with r/r B ALL at screening who achieve complete remission (CR) within 3 months of obe-cel infusion per Independent Response Review Committee (IRRC) assessment
CR per IRRC assessment at any time in B ALL
Overall remission rate (ORR) (CR + complete remission with incomplete recovery of counts [CRi]) per IRRC assessment at any time in B ALL
Minimal residual disease (MRD)-negative ORR per IRRC assessment at any time in B ALL
Event-free survival in B ALL
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