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HA-1 T Cell Immunotherapy for Relapsed/Refractory Acute Leukemia

This study is testing a new immunotherapy called HA-1 T cell receptor (TCR) T cells for people with acute leukemia that has come back or isn't responding to treatment after a donor stem cell transplant. The HA-1 T TCR T cells are made from your donor's T-cells and are designed to recognize and fight leukemia cells that have a specific protein called HA-1. Researchers want to see if these cells can be made successfully, if they can be given safely, and what side effects they might cause. To join, you must be between 0 and 80 years old, have a specific genetic marker (HLA-A*0201), and have the HA-1(H) genotype. You also need to have had a stem cell transplant from an adult donor. The study is currently recruiting up to 24 participants, but its overall status is unclear.

Study design
This is a dose-escalation study, meaning participants will receive increasing doses of the HA-1 TCR T cells to find the safest and most effective amount. It plans to enroll up to 24 participants.
What's involved
You would receive chemotherapy before getting the HA-1 TCR T cells intravenously (IV). You would also undergo bone marrow aspirations and blood sample collections.
Compensation
Not stated in the trial record.
Follow-up
You will be closely monitored for 12 weeks after receiving the T-cell infusion. After that, you will have follow-up visits every 6 months for 5 years, and then yearly for another 10 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03326921

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

Recruiting
PHASE1Up to 80InterventionalTreatment
Fred Hutchinson Cancer Center
~24 participants
Updated 2026-05-18 on ClinicalTrials.gov
What's tested:CD8+ and CD4+ Donor Memory T-cells-expressing HA1-Specific TCRBone Marrow AspirationBiospecimen Collection

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility of manufacturing minor H antigen (HA-1) T cell receptor (TCR) CD8+ and CD4+ T cells
Measured over At time of T cell infusion (at day 0)
+2 more outcomes measured

Conditions

Juvenile Myelomonocytic Leukemia
Recurrent Acute Biphenotypic Leukemia
Recurrent Acute Undifferentiated Leukemia
Recurrent Childhood Acute Lymphoblastic Leukemia
Recurrent Childhood Acute Myeloid Leukemia
Refractory Acute Lymphoblastic Leukemia
Refractory Adult Acute Lymphoblastic Leukemia
Blast Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive
Recurrent Blastic Plasmacytoid Dendritic Cell Neoplasm
Recurrent Myelodysplastic Syndrome
Refractory Blastic Plasmacytoid Dendritic Cell Neoplasm
Refractory Myelodysplastic Syndrome
Acute Undifferentiated Leukemia
Mixed Phenotype Acute Leukemia
Recurrent Chronic Myeloid Leukemia, BCR-ABL1 Positive
Refractory Chronic Myeloid Leukemia, BCR-ABL1 Positive
Recurrent Acute Lymphoblastic Leukemia
Recurrent Acute Myeloid Leukemia
Myelodysplastic Syndrome
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Acute Biphenotypic Leukemia
Chronic Myeloid Leukemia
Chronic Myelomonocytic Leukemia
Minimal Residual Disease
Recurrent Chronic Myelomonocytic Leukemia
Recurrent Mixed Phenotype Acute Leukemia
Leukemia
Chronic Myeloid Leukemia, BCR-ABL1 Positive

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Where it's being run

1 sites across 1 states
Washington1

Study leadership

  • Elizabeth Krakow · PRINCIPAL_INVESTIGATOR · Fred Hutch/University of Washington Cancer Consortium

Who to contact

FHCC Immunotherapy Intake
[email protected]
206-606-4668
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Subject age 0-80 years at the time of enrollment.
Subject must express HLA-A\*0201
Subject must have the HA-1(H) genotype (RS\_1801284: A/G, A/A)
Subject must have an adult donor for HCT who is adequately HLA matched by institutional standards (includes HLA-matched related or unrelated donors, and HLA-mismatched family donors, including haploidentical donors) and is either:
HLA-A\*0201 positive and HA-1(H) negative (RS\_1801284: G/G) or
HLA-A\*0201 negative
Subjects who are currently undergoing or who previously underwent allogeneic HCT for
Acute myeloid leukemia (AML) of any subtype
Acute lymphoid leukemia (ALL) of any subtype
Mixed phenotype/undifferentiated/any other type of acute leukemia, including blastic plasmacytoid dendritic cell neoplasm
Chronic myeloid leukemia with a history of blast crisis and:
With relapse or refractory disease (\>= 5% marrow blasts, or circulating blasts) at any time after HCT
With persistent rising minimal residual disease (defined as detectable disease by morphology, flow cytometry, molecular or cytogenetic testing but \< 5% marrow blasts by morphology, no circulating blasts on \>= 2 of two consecutive tests), refractory or ineligible for treatment with tyrosine kinase inhibitors at any time after HCT
Myelodysplastic syndrome (MDS) of any subtype
Chronic myelomonocytic leukemia (CMML)
Juvenile myelomonocytic leukemia (JMML)
Subjects must be able to understand and be willing to give informed consent; decision-impaired adults may consent with their legally authorized representative; parent or legal representative will be asked to consent for subjects younger than 18 years old
Subjects must agree to participate in long-term follow-up for up to 15 years if they are enrolled in the study and receive T cell infusion
Subjects who have relapsed or have MRD after HCT may receive other agents for treatment of disease and remain eligible for the protocol
A specific performance status score is not required for enrolling on the protocol; a delay in infusion of the HA-1 TCR T cells may be required for subjects with low performance status
Donor age \>= 18 years
Donors must be able to give informed consent

Exclusion

Medical or psychological conditions that would make the subject unsuitable candidate for cell therapy at the discretion of the principal investigator (PI)
Fertile subjects unwilling to use contraception during and for 12 months after treatment
Subjects with a life expectancy of \< 3 months of enrollment from coexisting disease other than leukemia
Subjects who have ongoing grade IV acute GVHD or severe chronic GVHD following most recent transplant. Exception: the principal investigator (PI) may make an exception on a case-by-case basis to include such a subject if there is doubt surrounding the GVHD diagnosis and/or sustained significant improvement in GVHD severity
The presence of organ toxicities will not necessarily exclude subjects from enrolling on the protocol at the discretion of the PI; however, a delay in the infusion of HA-1 TCR T cells may be required
Donors who are human immunodeficiency virus (HIV)-1, HIV-2, human T-lymphotropic virus (HTLV)-1, HTLV-2 seropositive or with active hepatitis B or hepatitis C virus infection
Unrelated donor residing outside of the United States of America (USA) unless the donor screening, testing and leukapheresis occur at an National Marrow Donor Program (NMDP)-affiliated and qualified donor center and are facilitated by the NMDP

What this trial measures

  • Feasibility of manufacturing minor H antigen (HA-1) T cell receptor (TCR) CD8+ and CD4+ T cellsAt time of T cell infusion (at day 0)

    Proportion of subjects for whom a HA-1 TCR T cell product can be produced.

  • Feasibility of administering minor H antigen (HA-1) T cell receptor (TCR) CD8+ and CD4+ T cellsAt time of T cell infusion (at day 0)

    Proportion of subjects for whom a HA-1 TCR T cell product can be administered.

  • Incidence of dose-limiting toxicities of HA-1 T cell receptor (TCR) T cellsUp to 12 weeks after T-cell infusion

    Toxicities will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.