drugset / Trial / NCT01795378
Safety and Efficacy Study of Donor Natural Killer Cells Given After Haploidentical Hematopoietic Cell Transplantation
Phase 1/2
Completed
56 enrolled
Asan Medical Center
Korea Research Institute of Bioscience & Biotechnology · collab
NaSingle-groupOpen-labelTreatment
Summary
The protocol treatment is to evaluate clinical effects of donor-derived natural killer cells that are given after HLA-mismatched hematopoietic cell transplantation.
Timeline
- Start
- 2013-02
- Primary completion
- 2015-05
- Completion
- 2015-05
Publications
- Background Lee KH, Lee JH, Lee JH, Kim DY, Seol M, Lee YS, Kang YA, Jeon M, Hwang HJ, Jung AR, Kim SH, Yun SC, Shin HJ. Reduced-intensity conditioning therapy with busulfan, fludarabine, and antithymocyte globulin for HLA-haploidentical hematopoietic cell transplantation in acute leukemia and myelodysplastic syndrome. Blood. 2011 Sep 1;118(9):2609-17. doi: 10.1182/blood-2011-02-339838. Epub 2011 Jun 28.
- Background Yoon SR, Lee YS, Yang SH, Ahn KH, Lee JH, Lee JH, Kim DY, Kang YA, Jeon M, Seol M, Ryu SG, Chung JW, Choi I, Lee KH. Generation of donor natural killer cells from CD34(+) progenitor cells and subsequent infusion after HLA-mismatched allogeneic hematopoietic cell transplantation: a feasibility study. Bone Marrow Transplant. 2010 Jun;45(6):1038-46. doi: 10.1038/bmt.2009.304. Epub 2009 Nov 2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | donor natural killer cell infusion | Cell therapy | 2e+07 cells/kg | — |
| Subject | donor natural killer cell infusion | Cell therapy | 5e+07 cells/kg | — |
| Subject | donor natural killer cell infusion | Cell therapy | 1e+08 cells/kg | — |
| Subject | donor natural killer cell infusion | Cell therapy | 2e+08 cells/kg | — |
| Subject | donor natural killer cell infusion | Cell therapy | 3e+08 cells/kg | — |
| Subject | donor natural killer cell infusion | Cell therapy | 4e+08 cells/kg | — |