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

NCT07271446 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2025-12-09

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

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

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.

Sponsors & Collaborators

  • Precision Biotech Taiwan Corp.

    lead INDUSTRY

Principal Investigators

  • Kuan-Der Lee, MD PhD · Department of Hematology and Oncology, Taipei Medical University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-01
Primary Completion
2019-08-01
Completion
2023-12-01

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07271446 on ClinicalTrials.gov