Study of Personalized Neo-DC Vaccine for Treating Advanced Solid Tumors Including Head and Neck Cancer and Non-Small Cell Lung Cancer

What this Trial Is About

Researchers are evaluating a personalized self-DC vaccine that targets neo-antigens Neo-DC vaccine for treating advanced solid tumors, including head and neck cancer and certain types of non-small cell lung cancer without driver gene mutations. This study aims to explore the dose-limiting toxicity and identify the recommended dose for future Neo-DC vaccine research. About 9 patients will be enrolled, following a 3 plus 3 dose escalation design with two dose levels. Participants will receive infusions of the Neo-DC vaccine at either a lower dose 1 x 107 cells per infusion or a higher dose 5 x 107 cells per infusion given every 7 days. Four infusions make up one treatment cycle. If clinical benefit or certain immune responses are observed, treatment cycles may continue until four administrations are completed, disease progression occurs, new anti-tumor treatments begin, or treatment is stopped for other reasons. Dose-limiting toxicity is monitored within 28 days after the first infusion. During the study, participants will be monitored for adverse events within 28 days of the first vaccine infusion. Researchers will also assess the objective response rate over up to 2 years and observe dose-limiting toxicities in the same 28-day window. Participants must complete all study procedures, including blood collections and tumor assessments based on RECIST 1.1 standards. The total participation duration varies depending on treatment continuation and disease status.

A Clinical Study of Personalized Self-DC Vaccine Targeting Neoantigen in Treatment of Advanced Solid Tumor