Trials / Not Yet Recruiting

Not Yet RecruitingNCT07347418

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

Phase 1, Open Label, Dose Escalation Study to Evaluate the Safety, Expansion, Persistence, and Preliminary Clinical Activity of Autologous CD64 CAR T Cells in Patients With Relapsed and/or Refractory Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndromes (HR-MDS)

Status: Not Yet Recruiting
Phase: Phase 1
Study type: Interventional
Enrollment: 23 (estimated)

Sponsor: University of Colorado, Denver · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

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) or high-risk myelodysplastic syndromes (MDS). 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 identify the safety profile and maximum tolerated dose (MTD) of CD64 CAR T in subjects with R/R AML or MDS as determined by the defined DLTs using a standard Bayesian Optimal Interval (BOIN) design.

Conditions

Interventions

Type	Name	Description
DRUG	CD64 CAR T Cells	CD64 CAR T is a lentiviral transduced autologous T cells expressing anti-CD64 chimeric antigen receptors (CAR) possessing tandem CD3ζ and 4-1BB (CD3ζ/4-1BB) costimulatory domains.

Timeline

Start date: 2026-03-01
Primary completion: 2029-03-01
Completion: 2029-12-01
First posted: 2026-01-16
Last updated: 2026-01-16

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT07347418. Inclusion in this directory is not an endorsement.