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NCT07645469 · ClinicalTrials.gov registry record · Phase 1

FH-WT1-E50 TCR T Cells With Azacitidine for the Treatment of Minimal Residual Disease Positive Acute Myeloid Leukemia

A Phase 1 study, sponsored by Fred Hutchinson Cancer Center.

Not yet
Registry status
Phase 1
Development phase
9
Enrollment target

NCT07645469: Clinical Trial Phase 1 study, sponsored by Fred Hutchinson Cancer Center.

NCT07645469 is a Phase 1 study that has not yet begun recruiting, run by Fred Hutchinson Cancer Center. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07645469, a Phase 1 study, has not yet begun recruiting, sponsored by Fred Hutchinson Cancer Center.

NOT YET RECRUITING
Registry status
Phase 1
Development phase
9 participants
Enrollment target

Study Summary

This phase I trial tests the safety, side effects and best dose of FH-WT1-E50 TCR T cells with azacitidine for the treatment of minimal residual disease (MRD) positive acute myeloid leukemia (AML). T cells are infection fighting blood cells that can kill tumor cells. The T cells given in this study will come from the patient and will have a new gene put in them that makes them able to recognize WT1, a protein on the surface of cancer cells. These WT1-specific T cells may help the body's immune system identify and kill WT1 cancer cells. Azacitidine is in a class of medications called antimetabolites. It works by stopping or slowing the growth of cancer cells. Giving FH-WT1-E50 TCR T Cells with azacitidine may be safe and/or effective for the treatment of MRD positive AML.

Interventions

  • PROCEDURE Biospecimen Collection
  • PROCEDURE Bone Marrow Aspiration
  • PROCEDURE Bone Marrow Biopsy
  • DRUG Azacitidine
  • DRUG Autologous HLA-A*02:01-restricted CD4+/CD8+ Anti-WT1 TCR/CD8ab-expressing T-cells

Trial Details

FieldValue
Enrollment Target 9 participants
Start Date 2026-10-01
Est. Completion 2030-07-19
Phase Phase 1
Fred Hutchinson Cancer Center

483 total trials

What is known before NCT07645469 opens enrollment

NCT07645469 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).

The record links to 0 conditions, and to 5 interventions - of which Biospecimen Collection is the first listed.

NCT07645469 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT07645469 about?

NCT07645469 is a clinical study titled "FH-WT1-E50 TCR T Cells With Azacitidine for the Treatment of Minimal Residual Disease Positive Acute Myeloid Leukemia". This phase I trial tests the safety, side effects and best dose of FH-WT1-E50 TCR T cells with azacitidine for the treatment of minimal residual disease (MRD) positive acute myeloid leukemia (AML). T cells are infection fighting blood cells that can kill tumor cells. The T cells given in this study ...

What is the current status of trial NCT07645469?

This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2026-10-01. Estimated completion is 2030-07-19.

What interventions are being tested in trial NCT07645469?

The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Azacitidine (DRUG), Autologous HLA-A*02:01-restricted CD4+/CD8+ Anti-WT1 TCR/CD8ab-expressing T-cells (DRUG).

Who is sponsoring clinical trial NCT07645469?

This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT07645469's enrollment target sits among peer trials

9 1955th of 2000 higher than 42 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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Source: ClinicalTrials.gov NCT07645469, the US trial registry maintained by the National Library of Medicine. NCT07645469 (small enrollment · none site footprint · not yet recruiting) retrieved and formatted by PlainTrial, see methodology.