An Open-Label, Multicenter, Randomized Phase II Study to Evaluate the Efficacy and Safety of Personalized Dendritic Cell Vaccine ZSNeo-DC1.1 in Combination With Temozolomide as Adjuvant Therapy in Patients With Newly Diagnosed Glioblastoma After Surgery and Concurrent Chemoradiotherapy
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 78
- 主要终点
- PFS
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Experimental
Personalized dendritic cell vaccine ZSNneo-DC1.1 in combination with temozolomide.
干预措施: Personalized Dendritic Cell Vaccine ZSNeo-DC1.1 (Biological)
Experimental
Personalized dendritic cell vaccine ZSNneo-DC1.1 in combination with temozolomide.
干预措施: Temozolomide (TMZ) (Drug)
Control
Standard adjuvant temozolomide chemotherapy alone
干预措施: Temozolomide (TMZ) (Drug)
结局指标
主要结局
PFS
时间窗: From randomization until disease progression or death, whichever occurs first，assessed up to 24 months
Progression-free survival assessed by an Independent Radiological Review Committee according to RANO 2.0 criteria
次要结局
- OS(From randomization until death from any cause，assessed up to 36 months)
- Overall Survival Rates(12 months, 18 months, and 24 months)
- Investigator-Assessed Progression-Free Survival(From randomization until disease progression or death，assessed up to 24 months)
- Disease Control Rate (DCR)(During treatment period)
- Best Overall Response (BOR)(During treatment period)
- 6. Clinical Benefit Rate (CBR)(During treatment period)
- Safety and Tolerability(From first dose until 30 days after last dose，assessed up to 24 months)