Enrolling by invitation NCT07520214

Clinical Study on the Safety and Immunogenicity of Specific Cancer Vaccines in Preventing Recurrence of Glioblastoma

Early Phase I Interventional Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype Glioblastom WHO Grade 4

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: mRNA vaccine: GV-907、GV-108.
Who it may be relevant to: Registry conditions: Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype, Glioblastom WHO Grade 4. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: China
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

This study evaluates the safety and specific antitumor immune responses of mRNA vaccines GV-108 and GV-907 in IDH-wildtype glioblastoma patients.

Biological mRNA vaccine: GV-907、GV-108
Eligible patients will receive intradermal injections of cancer vaccines

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]

Secondary outcome measures (3)

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.

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.
Patients with a history of severe allergies.
Patients with chronic diseases requiring long-term treatment with immunosuppressants or corticosteroids.
Pregnant or breastfeeding women.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

China · 1 center

NCT: NCT07520214 · KY2025-182-02