Personalized Cellular Vaccine Therapy in Treating Patients With Newly Diagnosed Glioblastoma (PerCellVac)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Incidence of treatment-emergent adverse events and severe adverse events [safety and Tolerability]
研究概览
简要总结
Dendritic cell-based cellular vaccine for tumor therapy has shown efficacy. This study is designed to perform a personalized clinical trial by first analyzing the expression of tumor associated antigens in patients with newly diagnosed glioblastoma and then immunizing the patients with personalized DC-based cellular vaccine. Immune responses to tumor antigens will be monitored. Safety and efficacy will be observed in the study.
详细描述
This is an open label, single-arm, single-institution, Phase I study designed to investigate the safety and efficacy of personalized cellular tumor vaccine for patients with newly diagnosed glioblastoma (GBM). Newly diagnosed GBM patients will undergo tumor resection. The tumors will be analyzed for the expression of a panel of glioma-associated antigens and immune-related genes. Post surgical treatment will be 6 weeks standard chemotherapy with temozolomide and concurrent radiotherapy and continue cycles of temozolomide within a 28-day window. Patients will undergo leukapheresis either after surgery or after concurrent radio/chemotherapy. Based on individual tumor antigen expression, in vitro transcribed mRNA will be generated and used to pulse in vitro generated DCs. The patients will be immunized i.d. and i.v. biweekly with DC cellular vaccines. Safety and efficacy will be monitored. The primary objective is to assess the safety of the personalized cellular vaccines. The secondary objective is to assess the specific T cell response to immunized vaccines. In addition, the antitumor efficacy of the vaccines will be measured using iRANO criteria, progression-free survival and overall survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed glioblastoma grade IV
- •Patients at the age of 18-
- •Patients must have undergone maximal surgical resection of the tumor.
- •Patients with Karnofsky scores > or =70
- •Patients with normal range of hematologic and metabolic test results.
- •Patients must have no corticosteroids treatment at least one week before vaccination.
- •Patients capable of understanding the study and signed informed consent.
排除标准
- •Breast feeding females.
- •Pregnant women.
- •Infectious diseases HIV, HBV, HCV
- •Documented immunodeficiency
- •Documented autoimmune disease
- •Any serious or uncontrolled medical or psychiatric conditions, for example, severe pulmonary, cardiac or other systemic disease.
- •Patient inability to participate as determined by PI discretion.
结局指标
主要结局
Incidence of treatment-emergent adverse events and severe adverse events [safety and Tolerability]
时间窗: 3 years since the beginning of the first vaccine
Incidence of adverse events and severe adverse events to measure safety and tolerability of mRNA-TAA pulsed autologous DC cellular vaccine
次要结局
- Antitumor antigen specific T cell response(4 weeks after the last vaccine)
- Overall survival(3 years since the beginning of the first vaccine)
- Progression-free survival(12 months since the beginning of the first vaccine.)
研究者
Jian Zhang
Jian Zhang, MD, Professor, Vice President of Guangdong 999 Brain Hospital, Chairman, Department of Surgery
Guangdong 999 Brain Hospital