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Enrolling by Invitation

NCT Number: NCT07520214

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

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

Enrolling by Invitation

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100050, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

mRNA vaccine: GV-907、GV-108

Biological

Eligible patients will receive intradermal injections of cancer vaccines

Primary outcomes

  1. Adverse Events

    Time frame: From baseline, assessed at every study visit through study completion, up to 96 weeks.

  2. Antigen-specific T cell responses in peripheral blood

    Time frame: Baseline, Weeks 8-9, 12, 24, 36, 48, 72, and 96

Secondary outcomes

  1. Progression-Free Survival

    Time frame: Up to 96 weeks.

  2. Overall Survival

    Time frame: Up to 96 weeks.

  3. Objective response rate

    Time frame: Up to 96 weeks.

Sponsors and collaborators

Lead sponsor

Beijing Neurosurgical Institute

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 9, 2026
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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