NCT07306299

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

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Glioma, High Grade

Interventions

Type	Name	Description
BIOLOGICAL	Glioma-related multi-target mRNA vaccines	Multi-targeted mRNA vaccines encoding the following GBM-associated mutations: H3.3K27M, H3.1K27M, H3.3G34R, BRAFV600E, PIK3CAH1047R, IDH1R132H, EGFRvIII

Timeline

• Start date: 2025-12-01
• Primary completion: 2028-01-01
• Completion: 2031-01-01
• First posted: 2025-12-29
• Last updated: 2025-12-29

Locations

1 site across 1 country: China