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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
Phase
Early Phase 1
Started
2025-09-10
Last updated
2026-04-09

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

FacilityCityRegionStatus
Beijing Tiantan Hospital Beijing Beijing Municipality
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