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.
Autolus Limited
Lead sponsor