Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype, Glioblastom WHO Grade 4
Conditions
Keywords
mRNA vaccine, Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype, cancer vaccine, Glioblastom WHO grade 4
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.
Interventions
BIOLOGICALmRNA vaccine: GV-907、GV-108
Eligible patients will receive intradermal injections of cancer vaccines
Sponsors
Beijing Neurosurgical Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| 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
| Measure | Time frame |
|---|---|
| Progression-Free Survival | Up to 96 weeks. |
| Overall Survival | Up to 96 weeks. |
| Objective response rate | Up to 96 weeks. |
Countries
China
Contacts
STUDY_DIRECTORFusheng Liu, MD,PhD
Beijing Tiantan Hospital
Outcome results
None listed