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

Part of paid clinical trials in Seattle, Washington.

Sponsor
Fred Hutchinson Cancer Center
Study ID
NCT07645469
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Autologous HLA-A*02:01-restricted CD4+/CD8+ Anti-WT1 TCR/CD8ab-expressing T-cells — DRUG
    Given IV
  • Azacitidine — DRUG
    Given IV
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Bone Marrow Aspiration — PROCEDURE
    Undergo bone marrow aspiration
  • Bone Marrow Biopsy — PROCEDURE
    Undergo bone marrow biopsy
  • Chest Radiography — PROCEDURE
    Undergo chest x-ray
  • Computed Tomography — PROCEDURE
    Undergo CT scan
  • Echocardiography Test — PROCEDURE
    Undergo echocardiography
  • Lumbar Puncture — PROCEDURE
    Undergo lumbar puncture
  • Multigated Acquisition Scan — PROCEDURE
    Given MUGA scan
  • Positron Emission Tomography — PROCEDURE
    Undergo PET scan

Study Details

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.

Key Dates

First listed
Jun 12, 2026
Start date
Aug 1, 2026
Status verified
Jun 2026
Primary completion
Jul 19, 2030
Completion
Jul 19, 2030

Study Design

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

Arms

  • Experimental: Treatment (FH-WT1-E50 TCR T cells, azacitidine)
    Patients undergo leukapheresis. 4 weeks later patients receive azacitidine IV. At least 4 weeks after the first azacitidine infusion, patients receive azacitidine IV followed by FH-WT1-E50 TCR T cells IV. If additional cells are available patients may receive a second infusion of azacitidine IV followed by FH-WT1-E50 TCR T cells IV, starting at 28 days, up to 1 year. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo MUGA scan/echocardiography and chest x-ray during screening and bone marrow biopsy and aspiration and blood sample collection throughout the study. Patients may undergo lumbar puncture on study and CT scan and/or PET scan throughout the study.

Primary Outcome Measure

Incidence of treatment related grade 3 or higher adverse events [ Time Frame: From first infusion up to 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109
Fred Hutch Immunotherapy Intake
[email protected]
206-606-4668
Francesco Mazziotta, MD, PhD (PRINCIPAL_INVESTIGATOR)

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