OncoMatch/Clinical Trials/NCT06152809
CIML NK Cells With Venetoclax for AML
Is NCT06152809 recruiting? Yes, currently enrolling (Sep 2026). This Phase 1 trial studies multiple treatments including Cytokine-Induced Memory-like Natural Killer Cells and Interleukin-2 for acute myeloid leukemia.
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) with measurable residual disease or oligoblastic (\< 20% blasts in the bone marrow) disease. 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)
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Other
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Chronic Lymphocytic Leukemia
Chronic Myeloid Leukemia
Biomarker criteria
Required: TP53 mutation
2022 ELN adverse risk mutations: Any one of the following mutations: Mutated TP53, ASXL1, BCOR, EZH2, RUNX1, SF3B1, SRSF2, STAG2, U2AF1, and/or ZRSR2
Required: ASXL1 mutation
2022 ELN adverse risk mutations: Any one of the following mutations: Mutated TP53, ASXL1, BCOR, EZH2, RUNX1, SF3B1, SRSF2, STAG2, U2AF1, and/or ZRSR2
Required: BCOR mutation
2022 ELN adverse risk mutations: Any one of the following mutations: Mutated TP53, ASXL1, BCOR, EZH2, RUNX1, SF3B1, SRSF2, STAG2, U2AF1, and/or ZRSR2
Required: EZH2 mutation
2022 ELN adverse risk mutations: Any one of the following mutations: Mutated TP53, ASXL1, BCOR, EZH2, RUNX1, SF3B1, SRSF2, STAG2, U2AF1, and/or ZRSR2
Required: RUNX1 mutation
2022 ELN adverse risk mutations: Any one of the following mutations: Mutated TP53, ASXL1, BCOR, EZH2, RUNX1, SF3B1, SRSF2, STAG2, U2AF1, and/or ZRSR2
Required: SF3B1 mutation
2022 ELN adverse risk mutations: Any one of the following mutations: Mutated TP53, ASXL1, BCOR, EZH2, RUNX1, SF3B1, SRSF2, STAG2, U2AF1, and/or ZRSR2
Required: SRSF2 mutation
2022 ELN adverse risk mutations: Any one of the following mutations: Mutated TP53, ASXL1, BCOR, EZH2, RUNX1, SF3B1, SRSF2, STAG2, U2AF1, and/or ZRSR2
Required: STAG2 mutation
2022 ELN adverse risk mutations: Any one of the following mutations: Mutated TP53, ASXL1, BCOR, EZH2, RUNX1, SF3B1, SRSF2, STAG2, U2AF1, and/or ZRSR2
Required: U2AF1 mutation
2022 ELN adverse risk mutations: Any one of the following mutations: Mutated TP53, ASXL1, BCOR, EZH2, RUNX1, SF3B1, SRSF2, STAG2, U2AF1, and/or ZRSR2
Required: ZRSR2 mutation
2022 ELN adverse risk mutations: Any one of the following mutations: Mutated TP53, ASXL1, BCOR, EZH2, RUNX1, SF3B1, SRSF2, STAG2, U2AF1, and/or ZRSR2
Required: NRAS mutation
Additional mutations associated with acquired resistance to venetoclax: Mutated NRAS, KRAS, FLT3 ITD/TKD
Required: KRAS mutation
Additional mutations associated with acquired resistance to venetoclax: Mutated NRAS, KRAS, FLT3 ITD/TKD
Required: FLT3 itd
Additional mutations associated with acquired resistance to venetoclax: Mutated NRAS, KRAS, FLT3 ITD/TKD
Required: 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
Cannot have received: organ transplant
received prior organ transplant
Cannot have received: donor lymphocyte infusion
received prior donor lymphocyte infusion (DLI) at any time
Cannot have received: CAR-T cell therapy
CAR-T cell or NK cell therapy at any time
Cannot have received: NK cell therapy
CAR-T cell or NK cell therapy at any time
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
left ventricular ejection fraction ≥ 40%; oxygen saturation ≥ 90% on room air
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; 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
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06152809 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior organ transplant, donor lymphocyte infusion, CAR-T cell therapy disqualifies patients from enrollment.
Does this trial require TP53?
Yes, TP53 mutation is a required biomarker for enrollment.
Does this trial require ASXL1?
Yes, ASXL1 mutation is a required biomarker for enrollment.
Does this trial require BCOR?
Yes, BCOR mutation is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify