Neoantigen-Pulsed Autologous Dendritic Cell Vaccine Combined With Temozolomide for Newly Diagnosed Glioblastoma

Inclusion criteria

Participants must meet all the following criteria to be eligible:

Inclusion criteria

• Age 18 to 75 years, inclusive
• Histologically confirmed newly diagnosed glioblastoma (WHO grade IV)
• Molecular diagnosis of IDH1/IDH2 wild-type
• Completion of tumor debulking surgery followed by standard concurrent chemoradiotherapy
• Karnofsky Performance Status (KPS) score of 50 to 100
• Adequate hematologic, hepatic, renal, and coagulation function
• Availability of sufficient tumor tissue and blood samples for neoantigen identification
• Adequate venous access for PBMC collection
• Life expectancy greater than 3 months
• Willingness to use effective contraception during study treatment and for 3 months thereafter
• Ability to understand and willingness to sign written informed consent

Exclusion criteria

Exclusion criteria

Subjects meeting any of the following criteria are ineligible:

• Not suitable for standard temozolomide-based chemoradiotherapy
• Prior participation in another interventional clinical trial within 4 weeks before randomization
• Prior implantation of carmustine wafers within 6 months
• Known hypersensitivity to temozolomide or dacarbazine
• Active autoimmune disease or requirement for systemic immunosuppressive therapy
• Active infection including HIV, active hepatitis B or C, or syphilis
• Use of systemic immunosuppressive therapy within 30 days before randomization
• Uncontrolled cardiovascular, metabolic, or systemic disease
• Pregnancy or breastfeeding
• Any condition that, in the investigator's judgment, would interfere with study participation or interpretation of results