HA-1 T TCR T Cell Immunotherapy for the Treatment of Patients With Relapsed or Refractory Acute Leukemia After Donor Stem Cell Transplant
NCT ID: NCT03326921
Last Updated: 2025-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
24 participants
INTERVENTIONAL
2018-02-23
2028-07-16
Brief Summary
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Detailed Description
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This is a dose-escalation study of CD4+ and CD8+ HA-1 TCR T cells.
Patients receive lymphodepleting chemotherapy (e.g., fludarabine and cyclophosphamide or debulking regimens as specified in the protocol) ending 2-14 days prior to HA-1 TCR T cell administration. Patients then receive CD4+ and CD8+ HA-1 TCR T cells intravenously (IV).
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.
Initial study activity was funded in part by HighPass Bio, Inc. Current study activity is funded in part by PromiCell Therapeutics, Inc.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (CD4+ and CD8+ HA-1 TCR T cells)
Patients receive lymphodepleting chemotherapy (e.g., fludarabine and cyclophosphamide or debulking regimens as specified in the protocol) ending 2-14 days prior to HA-1 TCR T cell administration. Patients then receive CD4+ and CD8+ HA-1 TCR T cells IV.
CD8+ and CD4+ Donor Memory T-cells-expressing HA1-Specific TCR
Given IV
Bone Marrow Aspiration
Undergo bone marrow aspiration
Biospecimen Collection
Undergo blood sample collection
Interventions
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CD8+ and CD4+ Donor Memory T-cells-expressing HA1-Specific TCR
Given IV
Bone Marrow Aspiration
Undergo bone marrow aspiration
Biospecimen Collection
Undergo blood sample collection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
80 Years
ALL
No
Sponsors
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HighPass Bio, Inc.
UNKNOWN
PromiCell Therapeutics, Inc.
UNKNOWN
Fred Hutchinson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Elizabeth Krakow
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Locations
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Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
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Central Contacts
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FHCC Immunotherapy Intake
Role: CONTACT
Phone: 855-557-0555
Facility Contacts
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FHCC Immunotherapy Intake
Role: primary
FHCC Immunotherapy Intake
Role: backup
References
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Krakow EF, Brault M, Summers C, Cunningham TM, Biernacki MA, Black RG, Woodward KB, Vartanian N, Kanaan SB, Yeh AC, Dossa RG, Bar M, Cassaday RD, Dahlberg A, Till BG, Denker AE, Yeung CCS, Gooley TA, Maloney DG, Riddell SR, Greenberg PD, Chapuis AG, Newell EW, Furlan SN, Bleakley M. HA-1-targeted T-cell receptor T-cell therapy for recurrent leukemia after hematopoietic stem cell transplantation. Blood. 2024 Sep 5;144(10):1069-1082. doi: 10.1182/blood.2024024105.
Other Identifiers
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NCI-2017-01054
Identifier Type: REGISTRY
Identifier Source: secondary_id
9716
Identifier Type: OTHER
Identifier Source: secondary_id
RG9217022
Identifier Type: OTHER
Identifier Source: secondary_id
9716
Identifier Type: -
Identifier Source: org_study_id