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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age12+
SponsorDana-Farber Cancer Institute

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

None

Trial design

Treatments tested in this trial

  • CIML NK
  • Fludarabine
  • Cyclophosphamide

Treatment groups

50 Participants
are divided into 1 treatment group

Sponsors and collaborators

Dana-Farber Cancer Institute

Lead sponsor

The Leukemia and Lymphoma Society

Collaborator