Phase I Study of a Universal mRNA Vaccine for Patients 16 and Older with Recurrent or Progressive High-grade Glioma

What this Trial Is About

Researchers are evaluating the safety and effectiveness of a universal mRNA vaccine designed to target a group of mutations commonly found in high-grade glioma, a type of brain tumor, in patients whose disease has recurred or progressed. This phase I clinical trial aims to determine whether the vaccine is safe and if it can trigger an immune response that helps reduce tumor growth. Participants will receive the glioma-related multi-targeted mRNA vaccine through a series of injections starting with one injection each week for four weeks. This is followed by one injection every four weeks for four cycles, and then maintenance injections every 12 weeks. The vaccine targets specific glioma mutations including H3.3K27M, H3.1K27M, H3.3G34R, BRAFV600E, PIK3CAH1047R, IDH1R132H, and EGFRvIII. During the study, participants will have regular follow-up visits at weeks 6 and 12, and months 6, 9, 12, 18, 24, and 36 after starting treatment. At these visits, researchers will closely monitor safety and any side effects, assess tumor growth, and evaluate the immune response to the vaccine. The study is expected to last several years, with ongoing assessments of vaccine safety and immune activity.

A Phase I Clinical Trial of a mRNA Vaccine for Recurrent or Progressive High-grade Glioma