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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 (Jun 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 Jun 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

Treatments studied

Other

CD8+ and CD4+ Donor Memory T-cells-expressing HA1-Specific TCR

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)

Demographics

Ages 0–80

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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Frequently asked questions

Is NCT03326921 currently recruiting?

Yes, this trial is currently recruiting patients.

Is prior treatment required for enrollment?

Yes. Patients must have previously received allogeneic hematopoietic cell transplant.

Does this trial require HLA-A?

Yes, HLA-A A*0201 positive is a required biomarker for enrollment.

Does this trial require HA-1?

Yes, HA-1 HA-1(H) genotype (RS_1801284: A/G, A/A) is a required biomarker for enrollment.

Is there an age limit?

Yes. Patients must be 80 years or younger and at least 0 years old.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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