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

Recruiting now · Phase 1

Conditions studied: 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

In brief

This 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.

Key facts

Study ID: NCT03326921
Run by: Fred Hutchinson Cancer Center
People needed: 24
Starts: 2018-02-23
Expected to finish: 2028-07-16
Last updated by the study team: 2026-05-18

Who can join

Age: any, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 SELECTION INCLUSION
Donor age >= 18 years
Donors must be able to give informed consent

You may not qualify if…

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
DONOR SELECTION EXCLUSION
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

Where it is running

Fred Hutch/University of Washington Cancer Consortium — Seattle, Washington, United States (enrolling)

Full record on ClinicalTrials.gov

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