drugset / Trial / NCT03366064
Haploidentical NK Cells After Pemetrexed in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC)
Phase 1
Completed
5 enrolled
Asan Medical Center
Korea Research Institute of Bioscience & Biotechnology · collab
NaSingle-groupOpen-labelTreatment
Summary
This phase 1 trial investigate safety and maximum tolerated dose of natural killer (NK) cells derived from haploidentical family donors in patients with non-small cell lung cancer
Timeline
- Start
- 2017-11-09
- Primary completion
- 2018-09-03
- Completion
- 2019-06-15
Publications
- 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.
- Background Lee KH, Lee JH, Lee JH, Kim DY, Park HS, Choi EJ, Ko SH, Seol M, Lee YS, Kang YA, Jeon M, Baek S, Kang YL, Kim SH, Yun SC, Kim H, Jo JC, Choi Y, Joo YD, Lim SN. Reduced-Intensity Conditioning with Busulfan, Fludarabine, and Antithymocyte Globulin for Hematopoietic Cell Transplantation from Unrelated or Haploidentical Family Donors in Patients with Acute Myeloid Leukemia in Remission. Biol Blood Marrow Transplant. 2017 Sep;23(9):1555-1566. doi: 10.1016/j.bbmt.2017.05.025. Epub 2017 May 25.
- Background Choi I, Yoon SR, Park SY, Kim H, Jung SJ, Jang YJ, Kang M, Yeom YI, Lee JL, Kim DY, Lee YS, Kang YA, Jeon M, Seol M, Lee JH, Lee JH, Kim HJ, Yun SC, Lee KH. Donor-derived natural killer cells infused after human leukocyte antigen-haploidentical hematopoietic cell transplantation: a dose-escalation study. Biol Blood Marrow Transplant. 2014 May;20(5):696-704. doi: 10.1016/j.bbmt.2014.01.031. Epub 2014 Feb 11.
- 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 Choi I, Yoon SR, Park SY, Kim H, Jung SJ, Kang YL, Lee JH, Lee JH, Kim DY, Lee JL, Park HS, Choi EJ, Lee YS, Kang YA, Jeon M, Seol M, Baek S, Yun SC, Kim HJ, Lee KH. Donor-Derived Natural Killer Cell Infusion after Human Leukocyte Antigen-Haploidentical Hematopoietic Cell Transplantation in Patients with Refractory Acute Leukemia. Biol Blood Marrow Transplant. 2016 Nov;22(11):2065-2076. doi: 10.1016/j.bbmt.2016.08.008. Epub 2016 Aug 12.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | donor-derived NK cells | Cell therapy | 1.25e+09 cells | Intravenous |
| Subject | donor-derived NK cells | Cell therapy | 2.5e+09 cells | Intravenous |
| Subject | donor-derived NK cells | Cell therapy | 5e+09 cells | Intravenous |
| Background | Pemetrexed | Small molecule | 500 mg/m2 | Intravenous |