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).
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06173518.
Locations matching your search criteria
United States
Utah
Salt Lake City
Primary Children's HospitalStatus: 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
evaluation, and follow-up.
Lead OrganizationAutolus Limited