Actively Recruiting
HA-1 T TCR T Cell Immunotherapy for the Treatment of Patients With Relapsed or Refractory Acute Leukemia After Donor Stem Cell Transplant
Led by Fred Hutchinson Cancer Center · Updated on 2025-11-14
24
Participants Needed
1
Research Sites
542 weeks
Total Duration
On this page
Sponsors
F
Fred Hutchinson Cancer Center
Lead Sponsor
H
HighPass Bio, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
HA-1 T TCR T Cell Immunotherapy for the Treatment of Patients With Relapsed or Refractory Acute Leukemia After Donor Stem Cell Transplant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 0 and 80 years at enrollment
- Expression of HLA-A*0201
- Presence of HA-1(H) genotype (A/G or A/A)
- Adult donor for stem cell transplant adequately HLA matched, either HLA-A0201 positive and HA-1(H) negative or HLA-A0201 negative
- Previous or current allogeneic stem cell transplant for acute myeloid leukemia, acute lymphoid leukemia, mixed phenotype/undifferentiated acute leukemia, blastic plasmacytoid dendritic cell neoplasm, chronic myeloid leukemia with blast crisis, myelodysplastic syndrome, chronic myelomonocytic leukemia, or juvenile myelomonocytic leukemia
- Ability to understand and provide informed consent or have a legal representative consent
- Willingness to participate in long-term follow-up for up to 15 years
- Patients with relapse or minimal residual disease after transplant may receive other treatments and remain eligible
- Donor age 18 years or older and able to give informed consent
You will not qualify if you...
- Medical or psychological conditions making the subject unsuitable for cell therapy as determined by the investigator
- Fertile subjects unwilling to use contraception during and for 12 months after treatment
- Life expectancy less than 3 months from other diseases besides leukemia
- Ongoing grade IV acute graft-versus-host disease (GVHD) or severe chronic GVHD after most recent transplant, except in special cases
- Organ toxicities may delay treatment at investigator discretion
- Donors positive for HIV-1, HIV-2, HTLV-1, HTLV-2, or with active hepatitis B or C infections
- Unrelated donors living outside the USA unless donor procedures occur at a qualified center affiliated with the National Marrow Donor Program
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
F
FHCC Immunotherapy Intake
CONTACT
F
FHCC Immunotherapy Intake
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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