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

NCT07520214 | Enrolling By Invitation Early Phase 1 DMC

• 1 other identifier: KY2025-182-02
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype; Glioblastom WHO Grade 4

Keywords

mRNA vaccine; Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype; cancer vaccine; Glioblastom WHO grade 4

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Progression-Free Survival

  Up to 96 weeks.

• Overall Survival

  Up to 96 weeks.

• Objective response rate

  Up to 96 weeks.

Study Arms (3)

GV-108 and GV-907 (100 µg/dose)

EXPERIMENTAL

Biological: mRNA vaccine: GV-907、GV-108

GV-108 and GV-907 (150 µg/dose)

EXPERIMENTAL

Biological: mRNA vaccine: GV-907、GV-108

GV-108 and GV-907 (200 µg/dose)

EXPERIMENTAL

Biological: mRNA vaccine: GV-907、GV-108

Interventions

mRNA vaccine: GV-907、GV-108 BIOLOGICAL

Eligible patients will receive intradermal injections of cancer vaccines

GV-108 and GV-907 (100 µg/dose); GV-108 and GV-907 (150 µg/dose); GV-108 and GV-907 (200 µg/dose)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Neurosurgical Institute: lead

Study Sites (1)

Beijing Tiantan Hospital

Beijing, Beijing Municipality, 100050, China

Location

Study Officials

• Fusheng Liu, MD,PhD

  Beijing Tiantan Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: April 9, 2026
• Study Start: September 10, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)