OncoMatch/Clinical Trials/NCT06138587
Preemptive CIML NK Cell Therapy After Hematopoietic Stem Cell Transplantation
Is NCT06138587 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 — 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
Treatments studied
Other
Cancer type
Acute Myeloid Leukemia
Chronic Myeloid 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 →Frequently asked questions
Is NCT06138587 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior allogeneic stem cell transplant, solid organ transplantation disqualifies patients from enrollment.
Does this trial require TP53?
Yes, TP53 mutation is a required biomarker for enrollment.
Are patients with FLT3 alterations eligible?
No. FLT3 ITD is an exclusion criterion.
Are patients with IDH1 alterations eligible?
No. IDH1 mutation is an exclusion criterion.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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