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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype; Glioblastom WHO Grade 4
• Intervention / Treatment: Biological: mRNA vaccine: GV-907、GV-108

• Study Type: Interventional
• Enrollment (Estimated): 9
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100050
      • Beijing Tiantan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GV-108 and GV-907 (100 µg/dose)	Biological: mRNA vaccine: GV-907、GV-108; Eligible patients will receive intradermal injections of cancer vaccines
Experimental: GV-108 and GV-907 (150 µg/dose)	Biological: mRNA vaccine: GV-907、GV-108; Eligible patients will receive intradermal injections of cancer vaccines
Experimental: GV-108 and GV-907 (200 µg/dose)	Biological: mRNA vaccine: GV-907、GV-108; Eligible patients will receive intradermal injections of cancer vaccines

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Progression-Free Survival	Up to 96 weeks.
Overall Survival	Up to 96 weeks.
Objective response rate	Up to 96 weeks.

Collaborators and Investigators

• Sponsor: Beijing Neurosurgical Institute
• Investigators: Study Director: Fusheng Liu, MD,PhD, Beijing Tiantan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: March 24, 2026
• First Submitted That Met QC Criteria: April 2, 2026
• First Posted (Actual): April 9, 2026

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 2, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: cancer vaccine; mRNA vaccine; Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype; Glioblastom WHO grade 4
• Other Study ID Numbers: KY2025-182-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No