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

Part of paid clinical trials in Seattle, Washington.

Sponsor
Fred Hutchinson Cancer Center
Study ID
NCT03326921
Phase
PHASE1
Status
Recruiting
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Conditions

  • Acute Biphenotypic Leukemia
  • Acute Lymphoblastic Leukemia
  • Acute Myeloid Leukemia
  • Acute Undifferentiated Leukemia
  • Blast Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive
  • Chronic Myeloid Leukemia
  • Chronic Myeloid Leukemia, BCR-ABL1 Positive
  • Chronic Myelomonocytic Leukemia
  • Juvenile Myelomonocytic Leukemia
  • Leukemia
  • Minimal Residual Disease
  • Mixed Phenotype Acute Leukemia
  • Myelodysplastic Syndrome
  • Recurrent Acute Biphenotypic Leukemia
  • Recurrent Acute Lymphoblastic Leukemia
  • Recurrent Acute Myeloid Leukemia
  • Recurrent Acute Undifferentiated Leukemia
  • Recurrent Blastic Plasmacytoid Dendritic Cell Neoplasm
  • Recurrent Childhood Acute Lymphoblastic Leukemia
  • Recurrent Childhood Acute Myeloid Leukemia
  • Recurrent Chronic Myeloid Leukemia, BCR-ABL1 Positive
  • Recurrent Chronic Myelomonocytic Leukemia
  • Recurrent Mixed Phenotype Acute Leukemia
  • Recurrent Myelodysplastic Syndrome
  • Refractory Acute Lymphoblastic Leukemia
  • Refractory Adult Acute Lymphoblastic Leukemia
  • Refractory Blastic Plasmacytoid Dendritic Cell Neoplasm
  • Refractory Chronic Myeloid Leukemia, BCR-ABL1 Positive
  • Refractory Myelodysplastic Syndrome

Eligibility Criteria

Sex
ALL
Age
N/A - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • CD8+ and CD4+ Donor Memory T-cells-expressing HA1-Specific TCR — BIOLOGICAL
    Given IV
  • Bone Marrow Aspiration — PROCEDURE
    Undergo bone marrow aspiration
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection

Study Details

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.

Key Dates

Start date
Feb 23, 2018
Status verified
May 2026
Primary completion
Oct 16, 2027
Completion
Jul 16, 2028

Study Design

Enrollment
24 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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.

Primary Outcome Measure

Feasibility of manufacturing minor H antigen (HA-1) T cell receptor (TCR) CD8+ and CD4+ T cells [ Time Frame: At time of T cell infusion (at day 0) ]

Central Contacts

  • FHCC Immunotherapy Intake
    206-606-4668
    [email protected]
  • FHCC Immunotherapy Intake
    855-557-0555

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109
FHCC Immunotherapy Intake
[email protected]
206-606-4668
FHCC Immunotherapy Intake
855-557-0555
Elizabeth Krakow (PRINCIPAL_INVESTIGATOR)

Find similar trials in Seattle, WA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Fred Hutch/University of Washington Cancer Consortium· Seattle, WA

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