At a glance
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A Phase I, Open-label Study to Evaluate Safety and Tolerability of PB101 in Combination With Standard Treatment, EGFR-TKI, in EGFR-mutated Advanced Non-small Cell Lung Cancer
In Brief
A Phase 1 clinical trial evaluating PB101 plus EGFR-TKI including gefitinib, erlotinib, afatinib, or osimertinib for Non-small Cell Lung Cancer. Completed, enrolled 8 participants across 1 site.
Detailed Summary
This study was designed to determine the safety and tolerability of PB101 (autologous NK cell product) in combination with standard of care EGFR-TKI in patients with EGFR-mutated advanced non-small cell lung cancer.
Study Details
Timeline
Interventions
This study will be conducted in one phase. Phase I will investigate safety of PB101. Subjects will be administered 1x10\^9*cells (\*allow +/-10% cell number) of PB101 over at least 30 minutes weekly for 4 weeks via intravenous infusions, 6 patients will be evaluated. Briefly, after re-visiting to the hospital in 7±3 days to confirm the safety, the subject will continue to be given 1x10\^9 cells of PB101 for the following four consecutive weeks.