Non-small Cell Lung Cancer Clinical Trial
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)
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
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.
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