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 (Jun 2026). This Phase 1 trial studies multiple treatments including CIML NK and Fludarabine for acute myeloid leukemia.
Treatment: CIML NK · Fludarabine · Cyclophosphamide — This 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Chemotherapy
Other
Cancer type
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Myeloproliferative Neoplasm
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
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 →Frequently asked questions
Is NCT04024761 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior Donor Lymphocyte Infusion disqualifies patients from 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