Status:
RECRUITING
HA-1 T TCR T Cell Immunotherapy for the Treatment of Patients With Relapsed or Refractory Acute Leukemia After Donor Stem Cell Transplant
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
HighPass Bio, Inc.
PromiCell Therapeutics, Inc.
Conditions:
Juvenile Myelomonocytic Leukemia
Recurrent Acute Biphenotypic Leukemia
Eligibility:
All Genders
Up to 80 years
Phase:
PHASE1
Brief Summary
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 (recurr...
Detailed Description
OUTLINE: 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 i...
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 SELECTION INCLUSION
- 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
- 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
Key Trial Info
Start Date :
February 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 16 2028
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03326921
Start Date
February 23 2018
End Date
July 16 2028
Last Update
November 14 2025
Active Locations (1)
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1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109