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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Patients are administered with donor-derived NK cells one week after pemetrexed infusion
Asan Medical Center - University of Ulsan College of Medicine
Seoul, South Korea
maximum tolerated dose of donor NK cells
determine the dose of NK cells that can be given within dose-limiting toxicities
Time frame: 6 weeks
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