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

NCT07306299 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-12-29

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

    lead OTHER

Principal Investigators

  • Yongjian Zhu, M.D., Ph.D · Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-01
Primary Completion
2028-01-01
Completion
2031-01-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07306299 on ClinicalTrials.gov