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

This clinical trial is designed to evaluate the safety and efficacy of a universal mRNA vaccine targeting a panel of glioma-associated mutations in patients with recurrent or progressive high-grade glioma. The primary objectives are to address the following key questions: 1) Is the mRNA vaccine safe for this patient population? 2) Does the vaccine stimulate an anti-tumor immune response and promote tumor regression? Participants will receive the vaccine according to the following schedule: 1. one injection per week for four consecutive weeks, followed by one injection every four weeks for four cycles, and subsequently, one injection every 12 weeks for maintenance. 2. Safety and efficacy assessments, including detailed recording of adverse events and tumor growth evaluation, will be conducted at follow-up visits scheduled for weeks 6, 12, and months 6, 9, 12, 18, 24, and 36 post-treatment initiation.

NCT Number	NCT07306299
Lead Sponsor	Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions	Glioma, High Grade
Enrollment	10 participants
Start Date	2025-12-01
Primary Completion	2028-01-01 (estimated)
Study Completion	2031-01-01 (estimated)
Updated on ClinicalTrials.gov	2025-12-29