HA-1-targeted T-cell receptor T-cell therapy for recurrent leukemia after hematopoietic stem cell transplantation.
Elizabeth F Krakow, Michelle Brault, Corinne Summers...
https://pubmed.ncbi.nlm.nih.gov/38683966Actively Recruiting
Phase 1
Age: 0 - 80Years
All Genders
ID03326921
Phase I Study of Adoptive Immunotherapy with CD8+ and CD4+ Memory T Cells Expressing an HA-1-Specific T Cell Receptor for Patients with Recurrent Acute Leukemia After Stem Cell Transplant
Led by Fred Hutchinson Cancer Center · Updated on 2026-05-18
24
Participants Needed
1
Research Sites
39 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
Researchers are evaluating the side effects and best dose of CD4+ and CD8+ HA-1 T cell receptor (TCR) T cells in treating patients with acute leukemia that persists, returns, or does not respond after a donor stem cell transplant. This phase I trial explores how genetically modified donor T cells can recognize leukemia cells by targeting the HA-1 protein on their surface. The study aims to better understand the feasibility and safety of this adoptive immunotherapy approach for leukemia patients post-transplant. Participants receive lymphodepleting chemotherapy, such as fludarabine and cyclophosphamide, ending 2 to 14 days before receiving the HA-1 TCR T cells intravenously. After T cell infusion, patients are closely followed for 12 weeks, then every 6 months for years 1 through 5, and annually for years 6 through 15. The study involves procedures like bone marrow aspirations and blood sample collections to monitor treatment effects. During the trial, researchers assess the ability to manufacture and administer the HA-1 TCR T cells, monitor dose-limiting toxicities within 12 weeks, and track how long the modified T cells persist in the blood and bone marrow for up to one year. They also evaluate the reduction of leukemia and normal recipient cells in bone marrow and observe any new or recurrent graft-versus-host disease symptoms for one year. Long-term follow-up up to 15 years helps ensure ongoing safety and effectiveness assessments.
CONDITIONS
Brief 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
Age: 0 - 80Years
All Genders
Eligibility Criteria
You may qualify if you...
- Subject age 0-80 years at enrollment
- Must express HLA-A*0201
- Must have the HA-1(H) genotype (RS_1801284: A/G, A/A)
- Must have an adult donor (age 18 or older) for stem cell transplant who is HLA matched and either HLA-A0201 positive and HA-1(H) negative or HLA-A0201 negative
- Diagnosed with acute myeloid leukemia, acute lymphoid leukemia, mixed phenotype acute leukemia, chronic myeloid leukemia with blast crisis, myelodysplastic syndrome, chronic myelomonocytic leukemia, or juvenile myelomonocytic leukemia
- Able to understand and give informed consent (or have legal representative consent for minors or decision-impaired adults)
- Agree to participate in long-term follow-up for up to 15 years
- May receive other treatments for relapse or minimal residual disease after transplant
- No specific performance status required; infusion may be delayed if performance is low
- Donors must be able to give informed consent
You will not qualify if you...
- Medical or psychological conditions making the subject unsuitable for cell therapy as decided by the investigator
- Fertile subjects unwilling to use contraception during and for 12 months after treatment
- Life expectancy less than 3 months due to diseases other than leukemia
- Ongoing grade IV acute graft-versus-host disease or severe chronic graft-versus-host disease after transplant, unless exceptions are made by the investigator
- Presence of organ toxicities may delay infusion but not necessarily exclude participation
- Donors seropositive for HIV-1, HIV-2, HTLV-1, HTLV-2 or with active hepatitis B or C infection
- Unrelated donors outside the USA unless screening and leukapheresis are done at approved centers
AI-Screening
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Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessments
Run-in Period
Duration - 2 to 14 days
Participants receive lymphodepleting chemotherapy ending 2 to 14 days before receiving HA-1 TCR T cell treatment.
Visits as needed for chemotherapy administration
Treatment
Duration - Single administration at day 0
Participants receive CD4+ and CD8+ HA-1 TCR T cells intravenously.
1 infusion visit (in-person)
Follow-up
Duration - Up to 15 years
Participants are closely followed for safety and treatment effects for 12 weeks, then every 6 months for years 1 through 5, and annually for years 6 through 15.
Frequent visits during first 12 weeks, then visits every 6 months for years 1-5, then yearly visits for years 6-15
Trial Site Locations
Total: 1 location
1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
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Research Team
F
FHCC Immunotherapy Intake
F
FHCC Immunotherapy Intake
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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