OncoMatch/Clinical Trials/NCT06152809
CIML NK Cells With Venetoclax for AML
Is NCT06152809 recruiting? Yes, currently enrolling (Jun 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). 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
Chronic Myeloid Leukemia
Biomarker criteria
Required: DEK::NUP214 t(6;9)(p23.3;q34.1)
2022 ELN adverse risk karyotype: t(6;9)(p23.3;q34.1)/DEK::NUP214
Required: KMT2A (MLL) rearrangement
2022 ELN adverse risk karyotype: t(v;11q23.3)/KMT2A-rearranged
Required: BCR::ABL1 t(9;22)(q34.1;q11.2)
2022 ELN adverse risk karyotype: t(9;22)(q34.1;q11.2)/BCR::ABL1
Required: KAT6A::CREBBP t(8;16)(p11.2;p13.3)
2022 ELN adverse risk karyotype: t(8;16)(p11.2;p13.3)/KAT6A::CREBBP
Required: GATA2 inv(3)(q21.3q26.2) or t(3;3)(q21.3;q26.2)
2022 ELN adverse risk karyotype: inv(3)(q21.3q26.2) or t(3;3)(q21.3;q26.2)/ GATA2
Required: MECOM inv(3)(q21.3q26.2) or t(3;3)(q21.3;q26.2)
2022 ELN adverse risk karyotype: inv(3)(q21.3q26.2) or t(3;3)(q21.3;q26.2)/ MECOM(EVI1)
Required: MECOM t(3q26.2;v)-rearranged
2022 ELN adverse risk karyotype: t(3q26.2;v)/MECOM(EVI1)-rearranged
Required: DEL(5Q) deletion
2022 ELN adverse risk karyotype: -5 or del(5q)
Required: -5 chromosome loss
2022 ELN adverse risk karyotype: -5 or del(5q)
Required: -7 chromosome loss
2022 ELN adverse risk karyotype: -7
Required: COMPLEX KARYOTYPE complex karyotype
2022 ELN adverse risk karyotype: Complex karyotype
Required: MONOSOMAL KARYOTYPE monosomal karyotype
2022 ELN adverse risk karyotype: monosomal karyotype
Required: TP53 mutation
2022 ELN adverse risk mutations: Mutated TP53
Required: ASXL1 mutation
2022 ELN adverse risk mutations: Mutated ASXL1
Required: BCOR mutation
2022 ELN adverse risk mutations: Mutated BCOR
Required: EZH2 mutation
2022 ELN adverse risk mutations: Mutated EZH2
Required: RUNX1 mutation
2022 ELN adverse risk mutations: Mutated RUNX1
Required: SF3B1 mutation
2022 ELN adverse risk mutations: Mutated SF3B1
Required: SRSF2 mutation
2022 ELN adverse risk mutations: Mutated SRSF2
Required: STAG2 mutation
2022 ELN adverse risk mutations: Mutated STAG2
Required: U2AF1 mutation
2022 ELN adverse risk mutations: Mutated U2AF1
Required: ZRSR2 mutation
2022 ELN adverse risk mutations: Mutated ZRSR2
Required: NRAS mutation
Additional mutations associated with acquired resistance to venetoclax: Mutated NRAS
Required: KRAS mutation
Additional mutations associated with acquired resistance to venetoclax: Mutated KRAS
Required: FLT3 ITD
Additional mutations associated with acquired resistance to venetoclax: FLT3 ITD/TKD
Required: FLT3 TKD
Additional mutations associated with acquired resistance to venetoclax: FLT3 ITD/TKD
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: hypomethylating agent + venetoclax (azacitidine, decitabine, 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: 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 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; 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 DEK::NUP214?
Yes, DEK::NUP214 t(6;9)(p23.3;q34.1) is a required biomarker for enrollment.
Does this trial require KMT2A?
Yes, KMT2A rearrangement is a required biomarker for enrollment.
Does this trial require BCR::ABL1?
Yes, BCR::ABL1 t(9;22)(q34.1;q11.2) 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