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

Обзор

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

Вмешательства

• Биопрепарат mRNA vaccine: GV-907、GV-108
  Eligible patients will receive intradermal injections of cancer vaccines

Первичные конечные точки

• Adverse Events [Срок оценки: From baseline, assessed at every study visit through study completion, up to 96 weeks.]
• Antigen-specific T cell responses in peripheral blood [Срок оценки: Baseline, Weeks 8-9, 12, 24, 36, 48, 72, and 96]

Вторичные конечные точки (3)

• Progression-Free Survival [Срок оценки: Up to 96 weeks.]
• Overall Survival [Срок оценки: Up to 96 weeks.]
• Objective response rate [Срок оценки: Up to 96 weeks.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Последовательный дизайн

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Beijing Tiantan Hospital — Пекин

Идентификаторы

NCT: NCT07520214 · KY2025-182-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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