NCT03366064

Haploidentical NK Cells After Pemetrexed in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC)

Phase I Trial of Haploidentical Natural Killer (NK) Cells in Combination With Pemetrexed in Patients With Stage IV Non-Small Cell Lung Cancer (NSCLC)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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

Detailed description

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.

Conditions

• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Pemetrexed and donor-derived NK cell infusion	Patients are administered with donor-derived NK cells one week after pemetrexed infusion

Timeline

• Start date: 2017-11-09
• Primary completion: 2018-09-03
• Completion: 2019-06-15
• First posted: 2017-12-08
• Last updated: 2019-07-08

Locations

1 site across 1 country: South Korea