RecruitingPhase 1NCT06152809

CIML NK Cells With Venetoclax for AML

A Phase 1 Study of Cytokine-induced Memory-like (CIML) NK Cells With Venetoclax as Consolidation Therapy in AML


Sponsor

Dana-Farber Cancer Institute

Enrollment

10 participants

Start Date

Feb 20, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this research study is to test the safety and to explore the effectiveness of infusing cytokine- induced memory-like (CIML) natural killer (NK) cells in combination with Interleukin-2 (IL-2) and standard-of-care venetoclax as a treatment for Acute Myeloid Leukemia (AML). Names of the study therapies involved in this study are: * Lymphodepleting therapy with Fludarabine and Cyclophosphamide prior to CIML NK cell infusion * CIML NK (a cellular therapy) * IL-2 (a recombinant, human glycoprotein) * Venetoclax (a selective inhibitor of BCL-2 protein)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether adding specially engineered natural killer (NK) immune cells (called CIML NK cells) to venetoclax — a targeted cancer drug — can help people with acute myeloid leukemia (AML) who are in remission but still have signs of remaining cancer (called measurable residual disease, or MRD). The goal is to use the immune cells to eliminate those last remaining cancer cells before they cause a relapse. **You may be eligible if...** - You are 18 years or older with a confirmed diagnosis of AML - You are currently being treated with azacitidine or decitabine plus venetoclax and have completed at least 1 cycle - Your AML has specific high-risk genetic features suggesting a higher chance of relapse - You are in reasonable health (ECOG ≤ 2) with adequate organ function **You may NOT be eligible if...** - You have had a prior allogeneic stem cell transplant, organ transplant, or prior CAR-T or NK cell therapy - You are HIV-positive or have active uncontrolled hepatitis B or C - You have an active autoimmune disease requiring significant steroids - You are pregnant or breastfeeding - You have a history of Grade 2 or higher hemolytic anemia 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 (under the skin) injection per protocol.

DRUGVenetoclax

Selective inhibitor of BCL-2 protein, 10, 50, or 100 mg tablets, via orally per standard-of-care.


Locations(2)

Brigham and Women's Hospital

Boston, Massachusetts, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

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NCT06152809


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