An Autologous NK/CIK Cell Product (PB101) in Combination With EGFR-TKI for Treating Lung Cancer

Sponsor
Precision Biotech Taiwan Corp.
Study ID
NCT07271446
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PB101 plus EGFR-TKI including gefitinib, erlotinib, afatinib, or osimertinib — BIOLOGICAL
    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.

Study Details

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.

Key Dates

Start date
Sep 1, 2018
Status verified
Dec 2025
Primary completion
Aug 1, 2019
Completion
Dec 1, 2023

Study Design

Enrollment
8 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Other: single arm
    This study is designed as an open-label, single-arm Phase I trial to evaluate the safety and tolerability of combining EGFR-TKI therapy with PB101, an autologous NK/NKT cell product. A single-arm design is appropriate for this early-stage investigation because the enrolled patient population consists of individuals with advanced EGFR-mutated NSCLC who have limited treatment options and for whom EGFR-TKI therapy alone often results in eventual acquired resistance. The primary objective at this stage is to assess the safety of adding PB101 to ongoing standard therapy rather than to compare efficacy outcomes between treatment groups.

Primary Outcome Measure

Safety assessment by Adverse events (AEs) [ Time Frame: From the beginning of the treatment to 1 year after completing 4 doses treatment ]

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