Donor Natural Killer Cell Infusion for the Prevention of Relapse or Graft Failure After HLA-Haploidentical Familial Donor Bone Marrow Transplantation-A Phase I Study
- To ascertain the safety of donor natural killer (NK) cells, generated from peripheral
blood hematopoietic stem cells, when given as a single intravenous infusion in patients
who have undergone HLA-haploidentical familial donor bone marrow transplantation (BMT).
- To determine the maximum tolerated dose of donor NK cells when given as a single
- To determine the effectiveness of donor NK cell infusion in preventing tumor relapse
and graft failure after HLA-haploidentical familial donor BMT.
OUTLINE: Patients receive donor natural killer cells as a single infusion over 1 hour.
Cohorts of 3-6 patients receive escalating doses of natural killer cells until the maximum
tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 3 or 3 of 6
patients experience grade III toxicities or acute graft-vs-host disease.
Primary Purpose: Treatment
Maximum tolerated dose of donor natural killer (NK) cells
Kyoo H. Lee, MD
Asan Medical Center
United States: Federal Government