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Clinical Trial Summary

The purpose of this research study is to test the safety and efficacy of cytokine induced memory-like (CIML) natural killer (NK) cells expanded with Interleukin-2 (IL-2) at preventing relapse in acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), or MDS and myeloproliferative neoplasm (MPN) overlap syndrome after a standard-of-care stem cell transplant. Names of the study therapies involved in this study are: - CIML NK cells intravenous infusion (cellular therapy) - Subcutaneous Interleukin-2 (recombinant, human glycoprotein)


Clinical Trial Description

This is a phase I/Ib study of the pre-emptive treatment using related donor-derived cytokine induced memory-like (CIML) natural killer (NK) cells combined with Interleukin-2 (IL-2) for participants with acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and MDS/myeloproliferative neoplasm (MDS/MPN) overlap syndrome at high risk for post-allogeneic stem cell transplant (SCT) relapse. The U.S. Food and Drug Administration (FDA) has not approved CIML NK cells as a treatment for AML, MDS or MDS and MPN overlap syndrome. The research study procedures include screening for eligibility, intravenous infusion of CIML NK cells in the hospital, standard-of-care stem cell infusion, subcutaneous interleukin-2 (IL-2) infusions, x-rays, Computerized Tomography (CT) scans, Magnetic Resonance Imaging (MRI) scans, Positron Emission Tomography (PET) scans, blood tests, bone marrow biopsies, echocardiograms, and electrocardiograms. Participation in this research study is expected to last up to 3 years. It is expected that up to 15 people will take part in this research study. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06138587
Study type Interventional
Source Dana-Farber Cancer Institute
Contact Roman Shapiro, MD
Phone 617-632-3470
Email roman_shapiro@dfci.harvard.edu
Status Recruiting
Phase Phase 1
Start date January 24, 2024
Completion date November 30, 2026

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