Donor NK Cell Infusion for Progression/Recurrence of Underlying Malignant Disorders After HLA-haploidentical HCT - a Phase 1-2 Study
- To assess the safety of donor natural killer (NK) cell infusion after
HLA-mismatched/haploidentical allogeneic hematopoietic stem cell transplantation from a
familial donor in patients with advanced malignant disorders.
- To determine the maximum number of donor NK cells that can be safely given to these
- To assess the clinical efficacy donor NK cell infusion, in terms of tumor response,
response duration, and survival, in patients with progressive or recurrent malignant
OUTLINE: This is a phase I, dose-escalation study followed by a phase II study.
- Phase I: Patients receive an infusion of donor natural killer (NK) cells on days 18 and
- Phase II: Patients receive an infusion of donor NK cells on days 14 and 21. After
completion of study treatment, patients are followed periodically.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Safety will be evaluation in terms of transplantation outcomes as well as side effects of donor NK cell infusion
15 days to 1 year after transplantation
Kyoo H. Lee, MD
Asan Medical Center
Korea: Food and Drug Administration