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)

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).

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.

Conditions3

Locations3 sites

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