Cytokine-induced Memory-like Natural Killer Cell Therapy After Hematopoietic Stem Cell Transplantation for Eradication of Measurable Residual Disease, a Phase I/Ib Clinical Trial
Dana-Farber Cancer Institute
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)
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,…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria for Trial Enrollment: * Histologically or cytologically confirmed diagnosis of AML, MDS, or MDS/MPN that is at high risk for post-transplant relapse and that has measurable disease prior to transplant, except for patients with TP 53 mutated disease who are eligible regardless of measurable residual disease. Patients at high risk for post-transplant relapse include: * De novo AML diagnosed at or after age 60, except CBF AML * De novo AML in CR1 AND MRD+ by Hematologics Inc. flow cytometry pretransplant (this would be on the most recent pre-transplant bone marrow) * Se…
Interventions
- BiologicalCytokine Induced Memory-like Natural Killer Cells
Allogeneic, cytokine induced memory-like natural killer cells, via intravenous infusion per protocol.
- BiologicalInterleukin-2
Recombinant, human glycoprotein, single-use 22 MIU vials, via subcutaneous injection per protocol.
Locations (2)
- Dana-Farber Cancer InstituteBoston, Massachusetts
- Brigham and Women's HospitalBoston, Massachusetts