Clinical trial · Interventional
Clinical Study on the Safety and Immunogenicity of Specific Cancer Vaccines in Preventing Recurrence of Glioblastoma
NCT07520214CI-TRIAL-00107794enrolling by invitationEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study evaluates the safety and specific antitumor immune responses of mRNA vaccines GV-108 and GV-907 in IDH-wildtype glioblastoma patients.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype | — | UNRESOLVED | — |
| Glioblastom WHO Grade 4 | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| mRNA vaccine: GV-907、GV-108 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- GV-108 and GV-907 (100 µg/dose)
- interventionNames
- Biological: mRNA vaccine: GV-907、GV-108
- type
- EXPERIMENTAL
- label
- GV-108 and GV-907 (150 µg/dose)
- interventionNames
- Biological: mRNA vaccine: GV-907、GV-108
- type
- EXPERIMENTAL
- label
- GV-108 and GV-907 (200 µg/dose)
- interventionNames
- Biological: mRNA vaccine: GV-907、GV-108
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.