Phase 1 Trial Explores Personalized Neoantigen DNA Vaccine for Glioblastoma Patients
A phase 1 clinical trial is investigating the safety and effectiveness of a personalized neoantigen DNA vaccine, GNOS-PV01, for patients with newly diagnosed MGMT unmethylated glioblastoma multiforme (GBM). The trial involves nine participants who received the vaccine following surgical resection and radiotherapy. The study aims to assess the vaccine's safety, feasibility, and immunogenicity. The vaccine is designed to target specific neoantigens identified through whole-exome sequencing of tumor samples. Patients received intramuscular vaccinations combined with a DNA plasmid encoding interleukin-12 as a molecular adjuvant. The trial's primary endpoint is to determine the safety and feasibility of the vaccine, with secondary endpoints including progression-free survival and overall survival rates.