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Cytokine-induced memory-like (CIML) natural killer (NK) cells in combination with IL-2,, to prevent acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) from coming back (relapse) after treatment with blood or marrow transplant (BMT) 

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18 and older

Phase 1

2 Locations

NCT06138587

Clinical Trial Goal


To find out:
  • The highest dose of CIML-NK cells that's safe to give in combination with IL-2
  • If CIML-NK cells and IL-2 are safe and work well to prevent relapse of AML or MDS

You may be able to join this trial if you:


  • Are 18 years old or older
  • Have one of the following that's at a high risk for relapse. Your doctor can tell you this:
    • AML
    • Chronic myelomonocytic leukemia (CMML)
    • MDS
    • MDS/myeloproliferative neoplasm (MPN)
  • Agree to have other standard tests done to see if you can be in the clinical trial

Trial Details


CIML-NK cells are a type of allogeneic (cells from a donor) immune cell that doctors think will attack and kill cancer cells. 
IL-2 is a drug that helps your immune system work better.
 
You’ll get the following after BMT:
  • CIML-NK cells – Given as an intravenous (IV) infusion 1 time. The dose you'll get depends on when you start the trial and how safe it has been
  • IL-2 – Given as a shot under your skin 1 time each day for 5 days

You'll have biopsies to see how well the treatment is working. The clinical trial doctors will check your health for 1 year.

The Food and Drug Administration (FDA) has not yet approved CIML-NK cells. IL-2 has been FDA approved for the treatment of some cancers. Using it in combination with CIML-NK cells to prevent relapse of AML or MDS is new and unproven. 

Contacts


Roman Shapiro, MD, 617-632-3470, roman_shapiro@dfci.harvard.edu

Locations


Brigham and Women's HospitalNOT_YET_RECRUITING

Boston, Massachusetts
Roman Shapiro, MD, 617-632-3470, roman_shapiro@dfci.harvard.edu

Dana-Farber Cancer InstituteRECRUITING

Boston, Massachusetts
Roman Shapiro, MD, 617-632-3470, roman_shapiro@dfci.harvard.edu

ClinicalTrials.gov record


NCT06138587. First posted on 11/18/23

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