Personalized Cellular Vaccine Therapy in Treating Patients With Brain Metastases From Solid Tumors
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
Cancer patients with brain metastases (BM) have poor prognosis. Current treatments produce limited efficacy. Recent advance in cancer immunotherapy has provided important new means to treat cancer patients at advanced stages. This study is designed to perform a clinical trial to treat advanced caner patients with brain metastases with personalized dendritic cell-based cellular vaccines. The patients will receive vaccines consisting of mRNA tumor antigen pulsed DCs. Immune response to the immunized tumor 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 tumor vaccines for cancer patients with brain metastases (BM). BM patients will undergo tumor resection or biopsy and the tumor tissues will be analyzed for the expression of tumor antigens and immune-related genes. The patients will be immunized with DCs pulsed with mRNA encoded tumor antigens. Patients will be immunized with DC vaccines on a biweekly basis. Safety and efficacy will be monitored. The objective of this study is to assess the safety of the personalized cellular vaccines and to deterimine the antitumor specific T cell responses. The efficacy of the vaccines will be determined using RANO-BM 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
- •Solid tumor with brain metastases.
- •Patients at the age of 18-
- •Patients undergo tumor resection or biopsy.
- •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
- •Infectious diseases HIV, HBV, HCV.
- •Documented immunodeficiency.
- •Documented autoimmune disease.
- •Breast feeding females.
- •Pregnant women.
- •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 vaccines.
次要结局
- Progression-free survival(24 months since the beginning of the first vaccine)
- Antitumor specific T cell response(4 weeks after the last vaccine)
- Overall survival(3 years since the beginning of the first vaccine)
研究者
Jian Zhang
Vice President of the hospital and Chief Physician
Guangdong 999 Brain Hospital