Clinical Trials in China / NCT07520214
Enrolling by invitation
Early Phase 1
Clinical Study on the Safety and Immunogenicity of Specific Cancer Vaccines in Preventing Recurrence of Glioblastoma
NCT07520214 · tracked via the Priya Life Science China tracker
Condition(s) studied
Glioblastoma IDH (Isocitrate Dehydrogenase) WildtypeGlioblastom WHO Grade 4
Investigational drug(s) / intervention(s)
mRNA vaccine: GV-907、GV-108
mRNA vaccine: GV-907、GV-108: Eligible patients will receive intradermal injections of cancer vaccines
Study summary
This study evaluates the safety and specific antitumor immune responses of mRNA vaccines GV-108 and GV-907 in IDH-wildtype glioblastoma patients.
Eligibility
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Primary outcome measure(s)
- Adverse Events — From baseline, assessed at every study visit through study completion, up to 96 weeks.
- Antigen-specific T cell responses in peripheral blood — Baseline, Weeks 8-9, 12, 24, 36, 48, 72, and 96
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Beijing Tiantan Hospital | Beijing | Beijing Municipality |
More Beijing Neurosurgical Institute trials in China
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07520214 on ClinicalTrials.gov ↗ ← All trials in China