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

Summary

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

Interventions

• mRNA vaccine: GV-907、GV-108 · BIOLOGICAL

  Eligible patients will receive intradermal injections of cancer vaccines

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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.

Sites (1)

• Beijing Tiantan Hospital, Beijing, Beijing Municipality