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

StatusRecruiting
PhasePhase 1
Started

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Record History

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  1. Start date changed from estimate of Dec 2026 to Sep 10, 2026
    • Eligibility criteria expanded, about 39 words
    • Secondary endpoints: details revised at 3 of 7 entries
  2. Start date: Jun 2026 to Dec 2026v4
  3. Recruitment opened
    • Site details revised
    v3
  4. Start date: Mar 2026 to Jun 2026v2 Show 5 more changesShow less
    • Primary completion pushed from Mar 2029 to Jun 2029
    • Study completion pushed from Dec 2029 to Jun 2032
    • Eligibility criteria expanded, about 179 words
    • Secondary endpoints: details revised at 3 of 7 entries
    • Study title shortened, about 2 words
  5. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07347418
Lead Sponsor University of Colorado, Denver
Conditions
(from sponsor)		 Refractory Acute Myeloid Leukemia (AML), Relapsed Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome, AML (Acute Myeloid Leukemia)
Related terms Leukemia, Myeloid, Acute, Myelodysplastic Syndromes
Enrollment 23 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov