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 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 antimetabo

Trial Details

NCT ID
NCT07645469
Phase
PHASE1
Sponsor
Fred Hutchinson Cancer Center
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Autologous HLA-A*02:01-restricted CD4+/CD8+ Anti-WT1 TCR/CD8ab-expressing T-cells
  • Azacitidine
  • Biospecimen Collection
  • Bone Marrow Aspiration
  • Bone Marrow Biopsy
  • Chest Radiography
Locations (sample)
  • Seattle, Washington, United States|47.60621,-122.33207

Key Eligibility Criteria

  • LEUKAPHERESIS: Age 18 years or older at the time of enrollment
  • LEUKAPHERESIS: Confirmed diagnosis of AML that is not M3 subtype (acute promyelocytic leukemia \[APL\])
  • LEUKAPHERESIS: Human leukocyte antigen (HLA) type HLA-A\*02:01 confirmed through HLA typing
  • LEUKAPHERESIS: Tissue confirmation of WT1 expression by immunohistochemistry. Confirmation of diagnosis must be or have been performed by internal …

For full eligibility, visit ClinicalTrials.gov.

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