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

This study will evaluate the safety of a novel autologous killer cell-based therapeutic product in patients with cancer. The trial targets patients with advanced EGFR-mutated non-small cell lung cancer (NSCLC) who continue EGFR-TKI therapy while receiving PB101-an autologous immune cell product expanded ex vivo and assessed for safety and potential efficacy. The objective is to evaluate the safety and tolerability of PB101 when administered as an adjunct autologous immune-cell therapy.

Autologous natural killer (NK) cells and natural killer T (NKT) cells possess the ability to recognize, remember, and eliminate cancer cells, as well as modulate the functions of other immune cells. Evidence from clinical applications and trials has shown that ex vivo-expanded autologous NK and NKT cells do not produce significant adverse effects and present no major safety concerns when used in cancer therapy. This study will apply our proprietary ex vivo expansion technology for autologous NK and NKT cells to clinically validate the safety and potential therapeutic activity of PB101 in patients with cancer.

This trial will enroll patients with stage III to IV lung cancer. Using our patented technology, autologous immune cells will be isolated and expanded ex vivo for approximately 15 ± 3 days to produce an NK- and NKT-enriched PB101 cell product for adjunctive clinical use. The safety of PB101 will be investigated in a cohort of six participants. Each participant will receive an intravenous infusion of 1 × 10⁹ autologous PB101 cells per dose, followed by a 2-hour post-infusion observation period before discharge. Participants will return for safety assessment 7 ± 3 days after each infusion and will subsequently receive the same dose weekly for a total of four consecutive weeks.

If any participant experiences a CTCAE v5.0 grade ≥3 adverse event during the study, safety data will be reviewed by the Data Safety Monitoring Board (DSMB), and enrollment or continuation of dose administration will proceed only after DSMB confirmation of safety. The presence or absence of adverse reactions among the six participants will determine the safety profile of the cell product and the maximum tolerated dose (MTD). A Phase II trial will be conducted based on Phase I results, expanding cohorts at a confirmed safe dose level to further evaluate clinical efficacy and therapeutic benefit.