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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
78
Patients receive six subcutaneous injections of ZSNeo-DC1.1 during adjuvant temozolomide chemotherapy. ZSNeo-DC1.1 is administered at a fixed dose of 1 × 10⁷ cells per injection according to the assigned immunization schedule. Temozolomide is administered as per protocol.
Patients receive standard adjuvant temozolomide chemotherapy alone
PFS
Progression-free survival assessed by an Independent Radiological Review Committee according to RANO 2.0 criteria
Time frame: From randomization until disease progression or death, whichever occurs first,assessed up to 24 months
OS
From randomization until death from any cause
Time frame: From randomization until death from any cause,assessed up to 36 months
Overall Survival Rates
Time frame: 12 months, 18 months, and 24 months
Investigator-Assessed Progression-Free Survival
Time frame: From randomization until disease progression or death,assessed up to 24 months
Disease Control Rate (DCR)
Time frame: During treatment period
Best Overall Response (BOR)
Time frame: During treatment period
6. Clinical Benefit Rate (CBR)
Time frame: During treatment period
Safety and Tolerability
Incidence and severity of adverse events and serious adverse events graded according to NCI CTCAE v5.0
Time frame: From first dose until 30 days after last dose,assessed up to 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.