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NCT07347418 · ClinicalTrials.gov registry record · Phase 1
CD64 CAR T Cell Therapy in Adults With Relapsed and/or Refractory AML
A Phase 1 study, sponsored by University of Colorado, Denver.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
NCT07347418: Recruiting Phase 1 study, sponsored by University of Colorado, Denver.
NCT07347418 is a Phase 1 study that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 23 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07347418, a Phase 1 study, is actively recruiting participants, sponsored by University of Colorado, Denver.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
Study 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). 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.
Primary Outcome
MTD will be established from the DLTs, which will be considered from the time of CD64 CAR T infusion (Day 0) through Day 42 after the subject's last infusion. A DLT is a treatment-emergent adverse event, or a clinically significant abnormal laboratory value, observed during the DLT observation period.
Interventions
- DRUG CD64 CAR T Cells
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2026-06 |
| Est. Completion | 2032-06 |
| Phase | Phase 1 |
What NCT07347418 shows while recruiting
NCT07347418 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 1 intervention - of which CD64 CAR T Cells is the first listed.
NCT07347418 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07347418 about?
NCT07347418 is a clinical study titled "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 domai...
What is the current status of trial NCT07347418?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2026-06. Estimated completion is 2032-06.
What interventions are being tested in trial NCT07347418?
The interventions under investigation include: CD64 CAR T Cells (DRUG).
Who is sponsoring clinical trial NCT07347418?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07347418's enrollment target sits among peer trials
23 1596th of 2000 higher than 400 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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