Glioblastoma IDH (Isocitrate Dehydrogenase) WildtypeEarly Phase 1NCT07520214
Clinical Study on the Safety and Immunogenicity of Specific Cancer Vaccines in Preventing Recurrence of Glioblastoma
A Early Phase 1 study testing mRNA vaccine: GV-907、GV-108 in people with Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype and Glioblastom WHO Grade 4, run by Beijing Neurosurgical Institute at 1 site in China.
Trial summary
This study evaluates the safety and specific antitumor immune responses of mRNA vaccines GV-108 and GV-907 in IDH-wildtype glioblastoma patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype, Glioblastom WHO Grade 4
- What is being tested?
- mRNA vaccine: GV-907、GV-108
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 10 Sep 2025to 31 Dec 2027
- Phase
- Early 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient must voluntarily sign the informed consent form and demonstrate good compliance during follow-up.
- Age ≥18 years, both male and female participants are eligible.
- Supratentorial IDH-wildtype glioblastoma located in the frontal, temporal, or occipital lobe with EGFR gene mutation; complete tumor resection confirmed by imaging within 10 days after initial surgery, followed by standard radiotherapy and/or chemotherapy; no tumor recurrence observed on MRI at 4 months postoperatively.
- Karnofsky Performance Status (KPS) score ≥60 before treatment.
- Normal immune function, bone marrow reserve, and normal liver and kidney function: absolute neutrophil count ≥1,500/mm³; hemoglobin ≥10 g/dL; platelet count ≥100,000/mm³; total bilirubin ≤1.5 × ULN; ALT/AST ≤2.5 × ULN; serum creatinine ≤1.5 × ULN; normal cardiac function.
- Women of childbearing age (15-49 years) must have a negative pregnancy test within 7 days prior to the start of treatment; male and female patients of reproductive potential must agree to use effective contraception during the study period and for 6 months after treatment.
Who cannot join
- Unwilling or unable to undergo treatment and follow-up assessments;
- History of brachial neuritis or Guillain-Barré syndrome.
- History of organ transplantation or currently awaiting organ transplantation;
- Uncontrolled infectious diseases or other serious conditions, such as HIV, or seropositivity for hepatitis B or hepatitis C.
- Any unstable systemic disease, including but not limited to: active infections, uncontrolled hypertension, unstable angina, newly onset angina within the past 3 months, congestive heart failure, myocardial infarction within 12 months prior to enrollment, severe arrhythmias requiring medical treatment, liver or renal failure.
- Patients with systemic autoimmune diseases or immunodeficiency disorders.
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- Patients with a history of severe allergies.
- Patients with chronic diseases requiring long-term treatment with immunosuppressants or corticosteroids.
- Pregnant or breastfeeding women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
This study evaluates the safety and specific antitumor immune responses of mRNA vaccines GV-108 and GV-907 in IDH-wildtype glioblastoma patients.
- Being tested
- mRNA vaccine: GV-907、GV-108
- Keywords
- mRNA vaccine, Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype, cancer vaccine, Glioblastom WHO grade 4
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mRNA vaccine: GV-907、GV-108Biological
Eligible patients will receive intradermal injections of cancer vaccines
| Study group | Role | What they receive |
|---|---|---|
| GV-108 and GV-907 (100 µg/dose) | Experimental | Not described Receives: Biological: mRNA vaccine: GV-907、GV-108 |
| GV-108 and GV-907 (150 µg/dose) | Experimental | Not described Receives: Biological: mRNA vaccine: GV-907、GV-108 |
| GV-108 and GV-907 (200 µg/dose) | Experimental | Not described Receives: Biological: mRNA vaccine: GV-907、GV-108 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Measured: From baseline, assessed at every study visit through study completion, up to 96 weeks.
Antigen-specific T cell responses in peripheral blood
Measured: Baseline, Weeks 8-9, 12, 24, 36, 48, 72, and 96
Secondary outcomes (3)
Progression-Free Survival
Measured: Up to 96 weeks.
Overall Survival
Measured: Up to 96 weeks.
Objective response rate
Measured: Up to 96 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2026
- Study start10 Sep 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioblastoma IDH (Isocitrate Dehydrogenase) WildtypeStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Neurosurgical Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fusheng Liu, MD,PhD, Study director, Beijing Tiantan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07520214
- Sponsor's protocol ID
- KY2025-182-02
- Status last verified
- Apr 2026
- First submitted
- 24 Mar 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Safety and Immunogenicity of Specific Cancer Vaccines in Preventing Recurrence of Glioblastoma
- ClinicalTrials.gov ID
- NCT07520214
- Acronym / sponsor ID
- KY2025-182-02
- Keywords
- mRNA vaccine, Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype, cancer vaccine, Glioblastom WHO grade 4
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Beijing Neurosurgical InstituteUniversity, hospital or other
- Study start
- 10 Sep 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 9 Apr 2026 (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 study evaluates the safety and specific antitumor immune responses of mRNA vaccines GV-108 and GV-907 in IDH-wildtype glioblastoma patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| GV-108 and GV-907 (100 µg/dose) | Experimental | Biological: mRNA vaccine: GV-907、GV-108 |
| GV-108 and GV-907 (150 µg/dose) | Experimental | Biological: mRNA vaccine: GV-907、GV-108 |
| GV-108 and GV-907 (200 µg/dose) | Experimental | Biological: mRNA vaccine: GV-907、GV-108 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The patient must voluntarily sign the informed consent form and demonstrate good compliance during follow-up.
- Age ≥18 years, both male and female participants are eligible.
- Supratentorial IDH-wildtype glioblastoma located in the frontal, temporal, or occipital lobe with EGFR gene mutation; complete tumor resection confirmed by imaging within 10 days after initial surgery, followed by standard radiotherapy and/or chemotherapy; no tumor recurrence observed on MRI at 4 months postoperatively.
- Karnofsky Performance Status (KPS) score ≥60 before treatment.
- Normal immune function, bone marrow reserve, and normal liver and kidney function: absolute neutrophil count ≥1,500/mm³; hemoglobin ≥10 g/dL; platelet count ≥100,000/mm³; total bilirubin ≤1.5 × ULN; ALT/AST ≤2.5 × ULN; serum creatinine ≤1.5 × ULN; normal cardiac function.
Key exclusion criteria (9 listed)
- Unwilling or unable to undergo treatment and follow-up assessments;
- History of brachial neuritis or Guillain-Barré syndrome.
- History of organ transplantation or currently awaiting organ transplantation;
- Uncontrolled infectious diseases or other serious conditions, such as HIV, or seropositivity for hepatitis B or hepatitis C.
- Any unstable systemic disease, including but not limited to: active infections, uncontrolled hypertension, unstable angina, newly onset angina within the past 3 months, congestive heart failure, myocardial infarction within 12 months prior to enrollment, severe arrhythmias requiring medical treatment, liver or renal failure.
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 |
|---|---|---|
| mRNA vaccine: GV-907、GV-108Eligible patients will receive intradermal injections of cancer vaccines | Biological | GV-108 and GV-907 (100 µg/dose), GV-108 and GV-907 (150 µg/dose), GV-108 and GV-907 (200 µg/dose) |
Primary outcome
Adverse Events
Time frame: From baseline, assessed at every study visit through study completion, up to 96 weeks.
Antigen-specific T cell responses in peripheral blood
Time frame: Baseline, Weeks 8-9, 12, 24, 36, 48, 72, and 96
3 secondary outcomes
Progression-Free Survival
Time frame: Up to 96 weeks.
Overall Survival
Time frame: Up to 96 weeks.
Objective response rate
Time frame: Up to 96 weeks.
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 9 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Fusheng Liu, MD,PhD study director
Beijing Tiantan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing mRNA vaccine: GV-907、GV-108 in people with Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype and Glioblastom WHO Grade 4, run by Beijing Neurosurgical Institute 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 6 inclusion and 9 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: enrolling by invitation, as of the sponsor's last update on 9 Apr 2026. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: From baseline, assessed at every study visit through study completion, up to 96 weeks.). The study lists 2 primary outcomes in all. 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 9 Apr 2026.