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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)
Trial Status: active
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).
Inclusion Criteria
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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06173518.
Locations matching your search criteria
United States
Colorado
Aurora
Children's Hospital Colorado
Status: Active
Name Not Available
Illinois
Chicago
Lurie Children's Hospital-Chicago
Status: Active
Name Not Available
Utah
Salt Lake City
Primary Children's Hospital
Status: Active
Name Not Available
This is a single-arm, open-label, multi-center, Phase 1b/2 study to determine the safety
and efficacy of obe-cel administered intravenously in pediatric patients < 18 years old
with r/r B ALL and with r/r aggressive mature B NHL.
The safety and tolerability of obe cel in pediatric patients will be continually
monitored by the Sponsor. Efficacy endpoints will be determined by an Independent
Response Review Committee (IRRC).
The study will involve consented patients going through the following sequential study
periods: screening, leukapheresis, bridging as necessary, lymphodepletion, treatment