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

  • End date
    Jul 16, 2025
  • participants needed
  • sponsor
    Fred Hutchinson Cancer Center
Updated on 21 April 2022
chronic myeloid leukemia
stem cell transplantation
myeloid leukemia
lymphoid leukemia
blast crisis
myelodysplastic syndromes
acute leukemia
flow cytometry
chronic myelomonocytic leukemia
minimal residual disease
residual tumor
blast cells
myelomonocytic leukemia
juvenile myelomonocytic leukemia


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.



This is a dose-escalation study of CD4+ and CD8+ HA-1 TCR T cells.

Patients receive fludarabine for 1-3 doses 3-14 days prior to HA-1 TCR T cell administration. Patients then receive CD4+ and CD8+ HA-1 TCR T cells intravenously (IV) over 1 hour.

After completion of study treatment, patients are followed up closely for 12 weeks and then every 6 months for years 1-5, and every year for years 6-15.

Condition 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 Myelogenous 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 Myelogenous Leukemia, BCR-ABL1 Positive, Refractory Chronic Myelogenous 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
Treatment fludarabine phosphate, laboratory biomarker analysis, Fludarabine, CD8+ and CD4+ Donor Memory T-cells-expressing HA1-Specific TCR
Clinical Study IdentifierNCT03326921
SponsorFred Hutchinson Cancer Center
Last Modified on21 April 2022


Yes No Not Sure

Inclusion Criteria

Patient age 0-75 years at the time of enrollment. Initially only patients who are >= 16 years old will receive HA-1-TCR T cell infusions on the protocol. Younger patients may be screened, enrolled in the protocol and monitored for relapse but will not be eligible for infusion until at least one patient >=16 years old has been treated and discussed with the Food and Drug Administration (FDA)
Patients must express HLA-A0201
Patients must have the HA-1(H) genotype (RS_1801284: A/G, A/A)
Patients 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-A0201 positive and HA-1(H) negative (RS_1801284: G/G) or
HLA-A0201 negative
Patients 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)
Patients must be able to understand and be willing to give informed consent
decision-impaired adults may consent with their legally authorized
Patients 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
Patients who have relapsed or have MRD after HCT may receive other agents for treatment of disease and remain eligible for the protocol
representative; parent or legal representative will be asked to consent for
patients younger than 18 years old
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 patients with low performance status
Donor age >= 18 years
Donors must be able to give informed consent
Patients 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-A0201 positive and HA-1(H) negative (RS_1801284: G/G) or
HLA-A0201 negative

Exclusion Criteria

Medical or psychological conditions that would make the patient unsuitable candidate for cell therapy at the discretion of the principal investigator (PI)
Fertile patients unwilling to use contraception during and for 12 months after treatment
Patients with a life expectancy < 3 months of enrollment from coexisting disease other than leukemia
Patients who develop grade IV acute GVHD or severe chronic GVHD following most recent transplant prior to enrollment on the protocol
The presence of organ toxicities will not necessarily exclude patients 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 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 NMDP-affiliated and qualified donor center and are facilitated by the NMDP
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