RecruitingPhase 1NCT06138587

Preemptive CIML NK Cell Therapy After Hematopoietic Stem Cell Transplantation

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


Sponsor

Dana-Farber Cancer Institute

Enrollment

15 participants

Start Date

Jan 24, 2024

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new type of immune cell therapy — called CIML NK cell therapy — given early (preemptively) after a stem cell transplant to patients with certain blood cancers who are at high risk of the cancer coming back. NK cells are a type of immune cell that naturally attacks cancer. **You may be eligible if...** - You have AML (acute myeloid leukemia), MDS (a pre-leukemia condition), or MDS/MPN overlap syndrome that is at high risk of relapse after transplant - You have had a blood stem cell transplant - You had measurable disease before the transplant (with some exceptions) - Your cancer falls into specific high-risk categories as defined by the study protocol **You may NOT be eligible if...** - Your cancer is not one of the qualifying types (AML, MDS, or MDS/MPN) - Your risk of relapse is not considered high by the study criteria - You do not meet organ function and blood count requirements after transplant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 Institute

Boston, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

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NCT06138587


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