Safety and Efficacy Study of Donor Natural Killer Cells Given After Haploidentical Hematopoietic Cell Transplantation

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

56

Participants

Timeline

Start Date

February 28, 2013

Primary Completion Date

May 31, 2015

Study Completion Date

May 31, 2015

Conditions
Acute Myelogenous LeukemiaAcute Lymphoblastic Leukemia
Interventions
BIOLOGICAL

donor natural killer cell infusion

"* Donor NK cells will be generated at the GCP laboratory at Asan Institute of Life Science by a team from Stem Cell Research Center, Korea Research Institute of Bioscience and Biotechnology.~* The patients will receive donor NK cell infusion (DNKI) around on days 6 and 9 (generated from the first collection), and around on days 13 and 20 (generated from the second collection).~* For DNKI to be given on days 6 and 9, a 3-patient cohort each will receive escalating dose of 2x10e7/kg, 5x10e7/kg, 1x10e8/kg, and 1-4 x10e8 cells.~* The dose of DNKI to be given on days 13 and 20 will be 1-4 x10e8/kg."

Trial Locations (1)

138-736

Asan Medical Center, Seoul

Sponsors
All Listed Sponsors
collaborator

Korea Research Institute of Bioscience & Biotechnology

OTHER_GOV

lead

Asan Medical Center

OTHER