Actively Recruiting
A Phase I Clinical Trial of a mRNA Vaccine for Recurrent or Progressive High-grade Glioma
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-12-29
10
Participants Needed
1
Research Sites
265 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Phase I Clinical Trial of a mRNA Vaccine for Recurrent or Progressive High-grade Glioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ability to understand the trial and provide written informed consent
- Male or female aged 16 years or older
- Histological or cytological confirmation of WHO Grade III or IV glioma with one or more specified mutations (H3.3K27M, H3.1K27M, H3.3G34R, BRAF V600E, PIK3CA H1047R, IDH1 R132H, or EGFRvIII)
- Recurrent or progressive high-grade glioma confirmed by MRI after standard therapy
- Life expectancy of at least 3 months
- Karnofsky Performance Status of 50 or higher
- No significant bone marrow, heart, lung, or kidney dysfunction as defined by specified laboratory and clinical criteria
- Adequate immune function with limited corticosteroid use
- Negative pregnancy test for women of childbearing potential; agreement to use effective contraception and no plans for pregnancy during the study period
You will not qualify if you...
- History of other cancers within the past 5 years, except certain treated conditions
- Known hypersensitivity to chemotherapy or radiosensitizers used for CNS or head and neck cancers
- History of severe allergic reactions to vaccines or components of the investigational product
- Positive tests for HIV, active Hepatitis C or B infection, or syphilis
- Active uncontrolled infections, tuberculosis, or immunosuppressive diseases
- Uncontrolled cardiovascular disease or serious psychiatric conditions
- Inability or unwillingness to provide informed consent
- Participation in other interventional clinical trials within 3 months prior to screening
- Severe infection within 2 weeks before first dose
- Receipt of live-attenuated vaccine within 4 weeks before first dose
- History of solid organ or stem cell transplantation
- Any other condition judged by the investigator to risk safety or protocol compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Room 521, Building 12, Jiefang Road Campus, The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
J
Jingyu Wang, M.D., Ph.D
CONTACT
Q
Qiangwei Wang, M.D., Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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