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Gene therapy, using T cells (HA-1 TCR) from a donor, to treat acute leukemia that has come back (relapsed) after getting an allogeneic (cells from a donor) blood or marrow transplant (BMT)

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75 and younger

Phase 1

1 Location

NCT03326921

Clinical Trial Goal


To find out:
  • The highest dose of HA-1 TCR T cells that is safe to give
  • If HA-1 TCR T cells are safe and work well to treat acute leukemia that has relapsed after allogeneic BMT

You may be able to join this trial if you:


  • Are 75 years old or younger
  • Have one of the following diseases that has relapsed or you still have a small amount of leukemia (minimal residual disease) after getting an allogeneic BMT
    • Acute lymphoblastic leukemia (ALL)
    • Acute myeloid leukemia (AML)
    • Biphenotypic or other type of acute leukemia
    • Chronic myeloid leukemia (CML) that was in blast phase
    • Chronic myelomonocytic leukemia (CMML)
    • Juvenille myelomonocytic leukemia (JMML)
    • Myelodysplastic syndrome (MDS)
  • Have the HLA type: HLA-A*0201 and the HA-1(H) genotype: (RS_1801284: A/G, A/A). Your doctor can tell you this
  • Agree to have other standard tests done to see if you can be in the clinical trial

Trial Details


HA-1 TCR T cells are made in a lab using T cells from a donor. The genes in the donor T cells are changed using gene therapy. This helps them find and kill leukemia cells.

Three days to 2 weeks before you get the treated T cells, you’ll get standard chemotherapy (chemo) with fludarabine to make room for the new T cells. You’ll get up to 3 doses.

Then, the HA-1 TCR T cells are given back to you through an intravenous (IV) infusion. The dose of cells you get depends on when you start the trial and how safe they have been. The infusion takes about 1 hour.

You’ll have biopsies to see how well the treatment is working. After you finish treatment, the clinical trial doctors will check your health for up to 15 years.

The Food and Drug Administration (FDA) has not yet approved this kind of gene therapy to treat acute leukemia.

Contacts


Jeff Huguenor
Tel: 206-667-2738
Email: jhugueno@fredhutch.org 

Locations


Fred Hutch/University of Washington Cancer ConsortiumRecruiting

Seattle, Washington
Contacts:

ClinicalTrials.gov record


NCT03326921

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