This is a multicenter, open-label, randomized Phase II clinical study designed to evaluate the efficacy and safety of a personalized dendritic cell (DC) vaccine, ZSNeo-DC1.1, in combination with temozolomide (TMZ) as adjuvant therapy in patients with newly diagnosed glioblastoma (GBM).
Eligible patients with histologically confirmed, IDH1/IDH2 wild-type newly diagnosed glioblastoma who have undergone tumor debulking surgery followed by standard concurrent chemoradiotherapy will be enrolled. After confirmation of tumor neoantigens and eligibility, patients will be randomized in a 1:1 ratio to receive either ZSNeo-DC1.1 in combination with TMZ or TMZ alone.
The primary objective is to evaluate progression-free survival (PFS) as assessed by an Independent Radiological Review Committee (IRRC) according to RANO 2.0 criteria. Secondary objectives include overall survival (OS), survival rates, tumor response outcomes, and safety. Exploratory objectives include assessment of antigen-specific T-cell immune responses induced by ZSNeo-DC1.1.
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
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