OncoMatch/Clinical Trials/NCT06138587
Preemptive CIML NK Cell Therapy After Hematopoietic Stem Cell Transplantation
Is NCT06138587 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.
Treatment: Cytokine Induced Memory-like Natural Killer Cells · Interleukin-2 — 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)
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Myelodysplastic Syndrome
Myeloproliferative Neoplasm
Biomarker criteria
Required: TP53 mutation
TP53-mutated MDS or AML
Excluded: FLT3 ITD
Participants with mutations such as FLT3-ITD, IDH, or BCR-ABL mutations who are planned to receive targeted agent maintenance therapy to prevent relapse post-transplant are excluded.
Excluded: IDH1 mutation
Participants with mutations such as FLT3-ITD, IDH, or BCR-ABL mutations who are planned to receive targeted agent maintenance therapy to prevent relapse post-transplant are excluded.
Excluded: IDH2 mutation
Participants with mutations such as FLT3-ITD, IDH, or BCR-ABL mutations who are planned to receive targeted agent maintenance therapy to prevent relapse post-transplant are excluded.
Excluded: BCR ABL fusion
Participants with mutations such as FLT3-ITD, IDH, or BCR-ABL mutations who are planned to receive targeted agent maintenance therapy to prevent relapse post-transplant are excluded.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: allogeneic stem cell transplant — planned
planned to undergo a standard-of-care reduced intensity conditioning (RIC) HLA-matched related or related haploidentical allogeneic stem cell transplant using PTCY-based GVHD prophylaxis
Cannot have received: allogeneic stem cell transplant
Exception: SOC alloHSCT referred to in this study taking place 7 days prior to CIML NK infusion
Prior history of allogeneic stem cell transplant other than SOC alloHSCT referred to in this study taking place 7 days prior to CIML NK infusion
Cannot have received: solid organ transplantation
Prior history of solid organ (allograft) transplantation
Lab requirements
Kidney function
Serum creatinine ≤ 2.0mg/dL
Liver function
Total 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
O2 saturation: ≥90% on room air; LVEF >40%
Adequate organ function within 2 weeks of NK cell infusion as defined below (should correspond with admission for SCT): * Total 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 * Serum creatinine ≤ 2.0mg/dL * O2 saturation: ≥90% on room air * LVEF >40%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Dana-Farber Cancer Institute · Boston, Massachusetts
- Brigham and Women's Hospital · Boston, Massachusetts
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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