Phase I Study of RNA-Lipid Particle Vaccines for Newly Diagnosed Adult Glioblastoma MGMT Low or Unmethylated and Pediatric High-Grade Gliomas

What this Trial Is About

Researchers are evaluating RNA-lipid Particle RNA-LP vaccines in a Phase I study for adults with newly diagnosed glioblastoma GBM who have low or unmethylated MGMT levels, and for pediatric patients with newly diagnosed high-grade gliomas pHGG. The study aims to test if these vaccines can be safely manufactured, identify the maximum tolerated dose, and assess safety in both adult and pediatric patients. This study is funded by the FDA OOPD and includes patients with specific tumor characteristics and treatment histories. Participants will undergo surgery to collect tumor tissue for creating personalized RNA-LP vaccines. After surgery and standard radiation therapy, patients receive three RNA-LP vaccines every two weeks, followed by 12 monthly booster vaccines, totaling 15 vaccinations. The adult GBM group is treated at a single site, while the pediatric group is treated across multiple sites. Vaccinations may continue for up to 14 months. During the study, participants will have MRI scans and clinical evaluations every three months during the first year after immunotherapy, then every 6 to 12 months for two more years to monitor disease progression. Researchers will assess vaccine manufacturing feasibility, safety up to 14 days after the third vaccine, and determine the maximum tolerated dose over up to 30 months. Participants will be followed until death from any cause.

A Study of RNA-lipid Particle (RNA-LP) Vaccines for Newly Diagnosed Pediatric High-Grade Gliomas (pHGG) and Adult Glioblastoma (GBM)