Glioma, High GradePhase 1NCT07306299
A Phase I Clinical Trial of a mRNA Vaccine for Recurrent or Progressive High-grade Glioma
A Phase 1 study testing Glioma-related multi-target mRNA vaccines in people with Glioma, High Grade, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Glioma, High Grade
- What is being tested?
- Glioma-related multi-target mRNA vaccines
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to 1 Jan 2031
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adequate compliance, ability to comprehend the clinical trial, and provision of written informed consent.
- Male or female, aged ≥16 years.
- Histologically or cytologically confirmed WHO Grade III or IV glioma harboring one or more of the following mutations: H3.3K27M, H3.1K27M, H3.3G34R, BRAF V600E, PIK3CA H1047R, IDH1 R132H, or EGFRvIII.
- Recurrent or progressive high-grade glioma, defined as a CNS WHO Grade 3-4 glioma confirmed by post-surgical histopathology, with documented recurrence or progression per RANO criteria on MRI following standard therapy (radiotherapy plus temozolomide chemotherapy).
- Life expectancy ≥3 months.
- Karnofsky Performance Status (KPS) ≥50. For subjects with spinal cord lesions, functional deficits due to paralysis will not be considered in the KPS assessment.
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- Absence of significant bone marrow, cardiac, pulmonary, or renal dysfunction, defined as:
- Hematologic (without transfusion or hematopoietic growth factor support within 14 days):
- Absolute Neutrophil Count (ANC) ≥1.5 × 10⁹/L
- Platelet count (PLT) ≥100 × 10⁹/L
- Hemoglobin (HGB) ≥90 g/L
- Hepatic Function:
- Alanine Aminotransferase (ALT) ≤2.5 × Upper Limit of Normal (ULN)
- Aspartate Aminotransferase (AST) ≤2.5 × ULN
- Total Bilirubin (TBIL) ≤1.5 × ULN
- Renal Function:
- Serum creatinine ≤1.5 × ULN OR estimated creatinine clearance ≥50 mL/min (calculated using the Cockcroft-Gault formula)
- Coagulation:
- Activated Partial Thromboplastin Time (APTT) ≤1.5 × ULN
- International Normalized Ratio (INR) ≤1.5 × ULN
- Other:
- Left Ventricular Ejection Fraction (LVEF) ≥50% without clinically significant pericardial effusion on echocardiogram
- No clinically significant electrocardiogram (ECG) abnormalities
- Baseline oxygen saturation >92% on room air
- Adequate immune function, defined as receiving dexamethasone ≤2 mg/day within the 3 days prior to screening without severe lymphopenia.
- Negative pregnancy test for women of childbearing potential (WOCBP); non-pregnant and non-lactating females; both male and female participants must agree to use highly effective contraception and have no plan for pregnancy within 6 months after study entry.
Who cannot join
- History of other malignancies within the past 5 years (except appropriately treated carcinoma in situ of the cervix or non-melanoma skin cancer).
- History of hypersensitivity to chemotherapy agents or radiosensitizers used for central nervous system or head and neck cancers.
- History of severe allergic reactions to vaccines or any components of the investigational product.
- Positive serology for:
- Human Immunodeficiency Virus (HIV) antibody
- Hepatitis C Virus (HCV) antibody with detectable HCV RNA
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- Hepatitis B Surface Antigen (HBsAg) with HBV DNA ≥2000 IU/mL
- Treponema pallidum (TP) antibody with a positive confirmatory test (e.g., RPR/TPPA)
- Active, uncontrolled infection, active tuberculosis, or active immunosuppressive disease.
- Any concurrent non-malignant illness or psychiatric condition that would preclude safe protocol participation; uncontrolled cardiovascular disease (e.g., coronary artery disease, angina, myocardial infarction, significant arrhythmias).
- Inability or unwillingness to provide informed consent or participate voluntarily.
- Concurrent participation in another interventional clinical trial or participation within 3 months prior to screening.
- Severe infection or signs/symptoms of active infection within 2 weeks prior to the first dose of the investigational product.
- Administration of a live-attenuated vaccine within 4 weeks prior to the first dose.
- History of solid organ or hematopoietic stem cell transplantation.
- Any other condition that, in the opinion of the investigator, would jeopardize the subject's safety or compliance with the study protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Qiangwei Wang, M.D., Ph.D contact
China1 site, 1 recruiting
- Recruiting
Room 521, Building 12, Jiefang Road Campus, The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
Jingyu Wang, M.D, Ph.D., +86 15990016248, wangjingyu1@zju.edu.cn
Qiangwei Wang, M.D, Ph.D., +86 17815700579
About this study
Official title: An Exploratory Phase I Clinical Trial of a Universal 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?
Read more
Participants will receive the vaccine according to the following schedule:
- 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.
- 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
- Being tested
- Glioma-related multi-target mRNA vaccines
- Keywords
- Glioma, mRNA vaccine, Mutation
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glioma-related multi-target mRNA vaccinesBiological
Also called mV002
Multi-targeted mRNA vaccines encoding the following GBM-associated mutations: H3.3K27M, H3.1K27M, H3.3G34R, BRAFV600E, PIK3CAH1047R, IDH1R132H, EGFRvIII
| Study group | Role | What they receive |
|---|---|---|
| mRNA vaccine treatment group | Experimental | Participants in this arm receive the glioma-related multi-trageted mRNA vaccine. Receives: Biological: Glioma-related multi-target mRNA vaccines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of a mRNA vaccine
All adverse events (AEs) treatment, emergent adverse events, treatment related toxici will be recorded. AE severity will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version [Specify Version, e.g., 5.0]. Dose-limiting toxicities (DLTs) are defined as occurring within the DLT observation period [Specify period, e.g., 28 days after the first dose] and include:
- Any CTCAE Grade 4 local injection site reaction.
- Any CTCAE Grade 3 local injection site reaction persisting for ≥2 weeks despite optimal supportive care.
- Any hypersensitivity reaction of at least CTCAE Grade 3 severity.
- CTCAE Grade 4 cerebral edema.
- Autoimmune reactions of CTCAE Grade 3 or higher.
- Any CTCAE Grade 4 hematologic toxicity (e.g., neutropenia, thrombocytopenia, anemia).
- CTCAE Grade 3 or higher non-hematologic organ toxicity, with the following
Measured: 2-3 years
Secondary outcomes (1)
Immune response to mRNA vaccine
The proportion of activated T cells and IFN-γ content in the peripheral blood, and the T cell receptor (TCR) targeting each mutation were measured after mRNA vaccine treatment.
Measured: 1-5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start1 Dec 2025
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioma, High GradeStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yongjian Zhu, M.D., Ph.D, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07306299
- Sponsor's protocol ID
- 2025LSYD1864
- Status last verified
- Dec 2025
- First submitted
- 14 Dec 2025
- Last updated
- 29 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD, all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Phase I Clinical Trial of a Universal mRNA Vaccine for Recurrent or Progressive High-grade Glioma
- ClinicalTrials.gov ID
- NCT07306299
- Acronym / sponsor ID
- 2025LSYD1864
- Conditions
- Glioma, High Grade
- Keywords
- Glioma, mRNA vaccine, Mutation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2031 (estimated)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mRNA vaccine treatment group | Experimental | Biological: Glioma-related multi-target mRNA vaccinesParticipants in this arm receive the glioma-related multi-trageted mRNA vaccine. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (26 listed)
- Adequate compliance, ability to comprehend the clinical trial, and provision of written informed consent.
- Male or female, aged ≥16 years.
- Histologically or cytologically confirmed WHO Grade III or IV glioma harboring one or more of the following mutations: H3.3K27M, H3.1K27M, H3.3G34R, BRAF V600E, PIK3CA H1047R, IDH1 R132H, or EGFRvIII.
- Recurrent or progressive high-grade glioma, defined as a CNS WHO Grade 3-4 glioma confirmed by post-surgical histopathology, with documented recurrence or progression per RANO criteria on MRI following standard therapy (radiotherapy plus temozolomide chemotherapy).
- Life expectancy ≥3 months.
Key exclusion criteria (16 listed)
- History of other malignancies within the past 5 years (except appropriately treated carcinoma in situ of the cervix or non-melanoma skin cancer).
- History of hypersensitivity to chemotherapy agents or radiosensitizers used for central nervous system or head and neck cancers.
- History of severe allergic reactions to vaccines or any components of the investigational product.
- Positive serology for:
- Active, uncontrolled infection, active tuberculosis, or active immunosuppressive disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glioma-related multi-target mRNA vaccinesAlso: mV002Multi-targeted mRNA vaccines encoding the following GBM-associated mutations: H3.3K27M, H3.1K27M, H3.3G34R, BRAFV600E, PIK3CAH1047R, IDH1R132H, EGFRvIII | Biological | mRNA vaccine treatment group |
Primary outcome
Safety and tolerability of a mRNA vaccine
Time frame: 2-3 years
All adverse events (AEs) treatment, emergent adverse events, treatment related toxici will be recorded. AE severity will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), version [Specify Version, e.g., 5.0]. Dose-limiting toxicities (DLTs) are defined as occurring within the DLT observation period [Specify period, e.g., 28 days after the first dose] and include: 1. Any CTCAE Grade 4 local injection site reaction. 2. Any CTCAE Grade 3 local injection site reaction persisting for ≥2 weeks despite optimal supportive care. 3. Any hypersensitivity reaction of at least CTCAE Grade 3 severity. 4. CTCAE Grade 4 cerebral edema. 5. Autoimmune reactions of CTCAE Grade 3 or higher. 6. Any CTCAE Grade 4 hematologic toxicity (e.g., neutropenia, thrombocytopenia, anemia). 7. CTCAE Grade 3 or higher non-hematologic organ toxicity, with the following
1 secondary outcome
Immune response to mRNA vaccine
Time frame: 1-5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2025.
- Individual participant dataSharing planned: Yes. all collected IPD, all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Qiangwei Wang, M.D., Ph.D contact
Yongjian Zhu, M.D., Ph.D principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Glioma-related multi-target mRNA vaccines in people with Glioma, High Grade, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 26 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jingyu Wang, M.D., Ph.D (+86 15990016248, wangjingyu1@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerability of a mRNA vaccine (time frame: 2-3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2025.