Haploidentical NK Cells After Pemetrexed in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC) (Medi-NK)
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|ClinicalTrials.gov Identifier: NCT03366064|
Recruitment Status : Completed
First Posted : December 8, 2017
Last Update Posted : July 8, 2019
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer||Biological: Pemetrexed and donor-derived NK cell infusion||Phase 1|
Eligible patients receive pemetrexed 500 mg/m2 intravenously (Day 1). On Day 8, patients receive donor-derived NK cells via a central venous catheter.
The NK cell dose is as follows;
Level 1: 1.25 X 109 cells Level 2: 2.50 X 109 cells Level 3: 5.00 X 109 cells
Three patients each will be treated on each dose level.
Two weeks prior to donor NK cell administration to patients, HLA-haploidentical family member of the patients undergo leukapheresis after G-CSF injections to collect hematopoietic stem cells.
These donor cells are then taken to the laboratory, where they were differentiated into NK cells ex vivo over approximately over 2-week period.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Trial of Haploidentical Natural Killer (NK) Cells in Combination With Pemetrexed in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC)|
|Actual Study Start Date :||November 9, 2017|
|Actual Primary Completion Date :||September 3, 2018|
|Actual Study Completion Date :||June 15, 2019|
Experimental: Pemetrexed and donor NK cell infusion
Eligible patients with stage 4 non-small cell lung cancer receive NK cells derived from HLA-haploidentical family donors. One week prior to NK cell infusion, patients receive pemetrexed (500 mg/m2) intravenous infusion
Biological: Pemetrexed and donor-derived NK cell infusion
Patients are administered with donor-derived NK cells one week after pemetrexed infusion
- maximum tolerated dose of donor NK cells [ Time Frame: 6 weeks ]determine the dose of NK cells that can be given within dose-limiting toxicities
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03366064
|Korea, Republic of|
|Asan Medical Center - University of Ulsan College of Medicine|
|Seoul, Korea, Republic of, 138-736|
|Principal Investigator:||Kyoo-Hyung Lee, MD||University of Ulsan, Asan Medical Center|