Clinical Trial

Study of Anti-CD33 Chimeric Antigen Receptor-Expressing T Cells (CD33CART) in Children and Young Adults With Relapsed/Refractory Acute Myeloid Leukemia

Active, Not Recruiting Phase 1/2
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Summary
This phase 1/2 trial aims to determine the safety and feasibility of antiCD33 chimeric antigen receptor (CAR) expressing T cells (CD33CART) in children and adolescents/young adults (AYAs) with relapsed/refractory acute myeloid leukemia (AML). The trial will be done in two phases: Phase 1 will determine the maximum tolerated dose of CD33CART cells using a 3+3 trial design, with dose-escalation for autologous products separated from dose-escalation for an allogeneic arm. Phase 2 is an expansion phase designed to evaluate the rate of response to CD33CART.
Protocol Amendment History 20 amendments
This ClinicalTrials.gov record has been amended 20 times since 2019-05-30; most recent amendment 2025-07-09.
Status change: Recruiting → Active, Not Recruiting 2025-07-09
Status change: Active, Not Recruiting → Recruiting 2025-06-16
Status change: Recruiting → Active, Not Recruiting 2025-06-06
Status change: Active, Not Recruiting → Recruiting 2024-05-13
Status change: Recruiting → Active, Not Recruiting 2023-11-27
Status change: Not Yet Recruiting → Recruiting 2020-01-08
Trial Details
NCT Number NCT03971799
Lead Sponsor Center for International Blood and Marrow Transplant Research
Collaborators: National Marrow Donor Program, St. Baldrick's Foundation
Conditions Acute Myelogenous Leukemia
Enrollment 52 participants
Start Date 2020-01-08
Primary Completion 2029-12 (estimated)
Study Completion 2039-12 (estimated)
Updated on ClinicalTrials.gov 2025-07-14