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OncoMatch/Clinical Trials/NCT03326921

HA-1 T TCR T Cell Immunotherapy for the Treatment of Patients With Relapsed or Refractory Acute Leukemia After Donor Stem Cell Transplant

Is NCT03326921 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies CD8+ and CD4+ Donor Memory T-cells-expressing HA1-Specific TCR for juvenile myelomonocytic leukemia.

Phase 1RecruitingFred Hutchinson Cancer CenterNCT03326921Data as of May 2026

Treatment: CD8+ and CD4+ Donor Memory T-cells-expressing HA1-Specific TCRThis phase I trial studies the side effects and best dose of CD4+ and CD8+ HA-1 T cell receptor (TCR) (HA-1 T TCR) T cells in treating patients with acute leukemia that persists, has come back (recurrent) or does not respond to treatment (refractory) following donor stem cell transplant. T cell receptor is a special protein on T cells that helps them recognize proteins on other cells including leukemia. HA-1 is a protein that is present on the surface of some peoples' blood cells, including leukemia. HA-1 T cell immunotherapy enables genes to be added to the donor cells to make them recognize HA-1 markers on leukemia cells.

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Acute Lymphoblastic Leukemia

Chronic Myeloid Leukemia

Myelodysplastic Syndrome

Biomarker criteria

Required: HLA-A A*0201 positive (A*0201 positive)

Subject must express HLA-A*0201

Required: HA-1 HA-1(H) genotype (RS_1801284: A/G, A/A) (A/G, A/A)

Subject must have the HA-1(H) genotype (RS_1801284: A/G, A/A)

Prior therapy

Min 1 prior line

Must have received: allogeneic hematopoietic cell transplant

Subjects who are currently undergoing or who previously underwent allogeneic HCT

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Fred Hutch/University of Washington Cancer Consortium · Seattle, Washington

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