CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 8 enrolled
Drug / intervention
PB101 plus EGFR-TKI including gefitinib, erlotinib, afatinib, or osimertinibbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT07271446
NCT07271446Phase 1Completed

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

Precision Biotech Taiwan Corp.·interventional·Posted Dec 9, 2025·Updated Dec 9, 2025

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesTaiwan
Collaborators--

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedDec 9, 2025
Enrollment StartSep 1, 2018
Primary CompletionAug 1, 2019
Study CompletionDec 1, 2023
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 7 months ago

Interventions

PB101 plus EGFR-TKI including gefitinib, erlotinib, afatinib, or osimertinibbiological

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.