Actively Recruiting
An Exploratory Phase I Clinical Trial of a Universal 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
156 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief 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
- Histologically or cytologically confirmed WHO Grade III or IV glioma with one or more specified mutations
- Recurrent or progressive high-grade glioma confirmed by post-surgical histopathology and MRI following standard therapy
- Life expectancy of at least 3 months
- Karnofsky Performance Status of 50 or higher
- Adequate bone marrow, liver, kidney, cardiac, and coagulation function as defined by specific laboratory values
- Adequate immune function with limited dexamethasone use prior to screening
- Negative pregnancy test for women of childbearing potential; agreement to use effective contraception for 6 months after study entry
You will not qualify if you...
- History of other cancers within the past 5 years (except certain treated cancers)
- History of severe allergic reactions to chemotherapy, radiosensitizers, vaccines, or vaccine components
- Positive tests for HIV, active Hepatitis B or C, or syphilis
- Active, uncontrolled infections or immunosuppressive diseases
- Uncontrolled cardiovascular disease or psychiatric conditions precluding safe participation
- Inability or unwillingness to provide informed consent
- Participation in another interventional clinical trial within 3 months prior to screening
- Severe infection within 2 weeks before the first vaccine dose
- Recent live-attenuated vaccine administration within 4 weeks before first dose
- History of solid organ or stem cell transplantation
- Any condition that may compromise safety or study compliance according to the investigator's judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 2 to 3 years
Participants receive glioma-related multi-targeted mRNA vaccines targeting specific glioma-associated mutations.
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
Q
Qiangwei Wang, M.D., Ph.D
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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