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

Phase 1/2 Active not recruiting 52 enrolled Center for International Blood and Marrow Transplant Research National Marrow Donor Program · collab St. Baldrick's Foundation · collab

Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2020-01-08
Primary completion: 2029-12
Completion: 2039-12

Publications

Qin H, Yang L, Chukinas JA, Shah N, Tarun S, Pouzolles M, Chien CD, Niswander LM, Welch AR, Taylor N, Tasian SK, Fry TJ. Systematic preclinical evaluation of CD33-directed chimeric antigen receptor T cell immunotherapy for acute myeloid leukemia defines optimized construct design. J Immunother Cancer. 2021 Sep;9(9):e003149. doi: 10.1136/jitc-2021-003149.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	CD33CART	Cell therapy	—	—

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

Summary

Timeline

Publications

Drugs

Indications