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

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT07347418
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

  • AML (Acute Myeloid Leukemia)
  • Myelodysplastic Syndrome
  • Refractory Acute Myeloid Leukemia (AML)
  • Relapsed Acute Myeloid Leukemia (AML)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CD64 CAR T Cells — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Jun 30, 2029
Completion
Jun 30, 2032

Study Design

Enrollment
23 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CD64 CAR T Infusion
    Patients with relapsed and/or refractory acute myeloid leukemia (AML) will receive lymphodepleting chemotherapy followed by infusion of CD64 CAR T-cells.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) [ Time Frame: Day 0 through Day 42 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado HospitalAuroraColorado80045
Derek Schatz
[email protected]
720-848-0628

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By research site
University of Colorado Hospital· Aurora, CO

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