CD64 CAR T Cell Therapy in Adults With Relapsed and/or Refractory AML

This is a Phase 1, open label, dose-escalation study to evaluate the safety, expansion, persistence, and preliminary clinical activity of lentivirally transduced autologous T cells expressing anti-CD64 chimeric antigen receptors (CAR) expressing tandem CD3ζ and 4-1BB (CD3ζ/4-1BB) costimulatory domains in subjects with refractory or relapsed (R/R) acute myeloid leukemia (AML). This CAR T cell product will be referred to as "CD64 CAR T" which is CD64 directed, autologous, genetically modified CAR T cells. The primary objective of the study is to identify the safety profile and maximum tolerated dose (MTD) of CD64 CAR T in subjects with R/R AML as determined by the defined DLTs using a standard Bayesian Optimal Interval (BOIN) design.

NCT Number	NCT07347418
Lead Sponsor	University of Colorado, Denver
Conditions	Refractory Acute Myeloid Leukemia (AML), Relapsed Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome, AML (Acute Myeloid Leukemia)
Enrollment	23 participants
Start Date	2026-06
Primary Completion	2029-06 (estimated)
Study Completion	2032-06 (estimated)
Updated on ClinicalTrials.gov	2026-06-29