OncoMatch/Clinical Trials/NCT06152809

CIML NK Cells With Venetoclax for AML

Is NCT06152809 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including Cytokine-Induced Memory-like Natural Killer Cells and Interleukin-2 for acute myeloid leukemia.

Phase 1RecruitingDana-Farber Cancer InstituteNCT06152809Data as of May 2026

Treatment: Cytokine-Induced Memory-like Natural Killer Cells · Interleukin-2 · Venetoclax — 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)

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Acute Lymphoblastic Leukemia

Biomarker criteria

Allowed: TP53 mutated

Any one of the following mutations: Mutated TP53, ASXL1, BCOR, EZH2, RUNX1, SF3B1, SRSF2, STAG2, U2AF1, and/or ZRSR2

Allowed: ASXL1 mutated

Any one of the following mutations: Mutated TP53, ASXL1, BCOR, EZH2, RUNX1, SF3B1, SRSF2, STAG2, U2AF1, and/or ZRSR2

Allowed: BCOR mutated

Any one of the following mutations: Mutated TP53, ASXL1, BCOR, EZH2, RUNX1, SF3B1, SRSF2, STAG2, U2AF1, and/or ZRSR2

Allowed: EZH2 mutated

Any one of the following mutations: Mutated TP53, ASXL1, BCOR, EZH2, RUNX1, SF3B1, SRSF2, STAG2, U2AF1, and/or ZRSR2

Allowed: RUNX1 mutated

Any one of the following mutations: Mutated TP53, ASXL1, BCOR, EZH2, RUNX1, SF3B1, SRSF2, STAG2, U2AF1, and/or ZRSR2

Allowed: SF3B1 mutated

Any one of the following mutations: Mutated TP53, ASXL1, BCOR, EZH2, RUNX1, SF3B1, SRSF2, STAG2, U2AF1, and/or ZRSR2

Allowed: SRSF2 mutated

Any one of the following mutations: Mutated TP53, ASXL1, BCOR, EZH2, RUNX1, SF3B1, SRSF2, STAG2, U2AF1, and/or ZRSR2

Allowed: STAG2 mutated

Any one of the following mutations: Mutated TP53, ASXL1, BCOR, EZH2, RUNX1, SF3B1, SRSF2, STAG2, U2AF1, and/or ZRSR2

Allowed: U2AF1 mutated

Any one of the following mutations: Mutated TP53, ASXL1, BCOR, EZH2, RUNX1, SF3B1, SRSF2, STAG2, U2AF1, and/or ZRSR2

Allowed: ZRSR2 mutated

Any one of the following mutations: Mutated TP53, ASXL1, BCOR, EZH2, RUNX1, SF3B1, SRSF2, STAG2, U2AF1, and/or ZRSR2

Allowed: NRAS mutated

Additional mutations associated with acquired resistance to venetoclax: Mutated NRAS, KRAS, FLT3 ITD/TKD

Allowed: KRAS mutated

Additional mutations associated with acquired resistance to venetoclax: Mutated NRAS, KRAS, FLT3 ITD/TKD

Allowed: FLT3 ITD

Additional mutations associated with acquired resistance to venetoclax: Mutated NRAS, KRAS, FLT3 ITD/TKD

Allowed: FLT3 TKD

Additional mutations associated with acquired resistance to venetoclax: Mutated NRAS, KRAS, FLT3 ITD/TKD

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Min 1 prior line

Must have received: hypomethylating agent (azacitidine, decitabine) — with venetoclax

at time of screening patient is being treated with HMA(azacitidine or decitabine) + venetoclax therapy and has received at least 1 cycle

Cannot have received: allogeneic stem cell transplant

Exception: allowed if > 6 months prior and no ongoing need for immunosuppressive therapy for active graft-versus-host disease

prior stem cell transplant is > 6 months prior with no ongoing need for immunosuppressive therapy for active graft-versus-host disease

Cannot have received: organ transplant

Prior allogeneic stem cell transplant, organ transplant or donor lymphocyte infusion (DLI), CAR-T cell or NK cell therapy

Cannot have received: donor lymphocyte infusion

Prior allogeneic stem cell transplant, organ transplant or donor lymphocyte infusion (DLI), CAR-T cell or NK cell therapy

Cannot have received: CAR-T cell therapy

Prior allogeneic stem cell transplant, organ transplant or donor lymphocyte infusion (DLI), CAR-T cell or NK cell therapy

Cannot have received: NK cell therapy

Prior allogeneic stem cell transplant, organ transplant or donor lymphocyte infusion (DLI), CAR-T cell or NK cell therapy

Lab requirements

Kidney function

creatinine clearance ≥ 45 mL/min; calculated by the Cockcroft Gault formula

Liver function

Direct bilirubin: ≤1.5 x institutional upper limit of normal (ULN) (except Gilbert's or disease-related hemolysis, then < 3 x ULN); AST(SGOT)/ALT(SGPT): ≤3 x institutional ULN

Cardiac function

oxygen saturation ≥ 90% on room air; left ventricular ejection fraction ≥ 40%

Participants must meet the following organ function as defined below: Direct bilirubin: ≤1.5 x institutional upper limit of normal (ULN) (except Gilbert's or disease-related hemolysis, then < 3 x ULN); AST(SGOT)/ALT(SGPT): ≤3 x institutional ULN; creatinine clearance ≥ 45 mL/min; calculated by the Cockcroft Gault formula; oxygen saturation ≥ 90% on room air; left ventricular ejection fraction ≥ 40%

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

Brigham and Women's Hospital · Boston, Massachusetts
Dana-Farber Cancer Institute · Boston, Massachusetts

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