This is a single institution, open-label, single arm, study assessing the safety, feasibility, and immunogenicity of a personalized neoantigen-based vaccine in subjects with newly diagnosed, unmethylated glioblastoma.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Safety and Tolerability of a Personalized Neoantigen DNA Vaccine as Measured by Number of Participants With Dose-limiting Toxicities (DLTs)
Timeframe: Up to 30 days
Feasibility of Generating a Personalized Neoantigen DNA Vaccine for Patients With Newly Diagnosed, Unmethylated GBM as Measured by the Number of Participants Who Had Candidate Tumor-specific Neoantigens Identified
Timeframe: 4 weeks post-completion of radiotherapy (day 1 of cycle 1)
Feasibility of Generating a Personalized Neoantigen DNA Vaccine for Patients With Newly Diagnosed, Unmethylated GBM as Measured by the Number of Participants With a Manufactured Neoantigen-based DNA Vaccine
Timeframe: 4 weeks post-completion of radiotherapy (day 1 of cycle 1)
Feasibility of Generating a Personalized Neoantigen DNA Vaccine for Patients With Newly Diagnosed, Unmethylated GBM as Measured by the Number of Participants Who Had the First Vaccine Administered at 4 Weeks Post-completion of Radiotherapy
Timeframe: 4 weeks post-completion of radiotherapy (estimated to be day 1 of cycle 1)