Personalized Cellular Vaccine Therapy in Treating Patients With Recurrent Glioblastoma (PerCellVac2)
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
The treatment option for recurrent glioblastoma is limited. Immune cell based therapy for glioblastoma has shown some efficacy. This study is designed to perform a personalized clinical trial by first analyzing the expression of tumor associated antigens in patients with recurrent glioblastoma and then immunizing the patients with personalized antigen pulsed DCs. Immune responses to the immunized antigens will be monitored. Safety and efficacy will be observed in this 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 vaccines for patients with recurrent glioblastoma (GBM). Recurrent 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. Patients will undergo leukapheresis to collect mononuclear cells for DC generation. Based on the expression profiles of tumor-associated antigens, in vitro transcribed mRNA will be generated to pulse autologous DCs. Patients will be conditioned with immune adjuvants before and during immunization. Patients will receive biweekly vaccines. The antitumor specific T cell responses will be measured. Safety and efficacy will be monitored. The objective is to assess the safety of the personalized cellular vaccines and T cell responses. The efficacy of the vaccines will be evaluated 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
- •Recurrent glioblastoma grade IV
- •Patients at the age of 18-
- •Patients undergo tumor resection.
- •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, allogeneic PBMCs and autologous tumor cellular vaccines.
次要结局
- Overall survival(3 years since the beginning of the first vaccine)
- Antitumor antigen specific T cell response(4 weeks after the last vaccine)
- Progression-free survival(12 months since the beginning of the first vaccine)
研究者
Jian Zhang
Vice President of the hospital and Chief Physician
Guangdong 999 Brain Hospital