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OncoMatch/Clinical Trials/NCT04024761

A Phase 1 Trial of CIML NK Cell Infusion for Myeloid Disease Relapse After Hematopoietic Cell Transplantation

Is NCT04024761 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including CIML NK and Fludarabine for acute myeloid leukemia.

Phase 1RecruitingDana-Farber Cancer InstituteNCT04024761Data as of May 2026

Treatment: CIML NK · Fludarabine · CyclophosphamideThis research study is studying cytokine induced memory-like natural killer (CIML NK) cells combined with IL-2 in adult patients (18 years of age or older) with Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS) and Myeloproliferative Neoplasms (MPN) who relapse after haploidentical hematopoietic cell transplantation (haplo-HCT) or HLA matched stem cells. This study will also study CIML NK cell infusion combined with IL-2 in pediatric patients (12 years of age or older) with AML, MDS, JMML who relapse after stem cell transplantation using HLA-matched related donor or related donor haploidentical stem cells.

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Myelodysplastic Syndrome

Myeloproliferative Neoplasm

Acute Lymphoblastic Leukemia

Performance status

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

Prior therapy

Must have received: stem cell transplant — allogeneic

at least 2 months after stem cell transplantation

Cannot have received: Donor Lymphocyte Infusion

Exception: DLI given >8 weeks before CIML NK infusion and did not result in GVHD requiring systemic treatment is not an exclusion criterion

Prior history of Donor Lymphocyte Infusion (DLI) within 8 weeks of CIML NK infusion

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: 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

  • Boston Children's Hospital · Boston, Massachusetts
  • Dana Farber Cancer Institute · Boston, Massachusetts

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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