Personalized Immune Cell Therapy Targeting Neoantigen of Malignant Solid Tumors
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related adverse events as events as assessed by CTCAE v4.0
研究概览
简要总结
This single center, single arm and prospective study aimed to establish gene mutation database and select the neoantigens in patients with advanced malignant melanoma, bladder cancer and colorectal cancer. Then, we intended to explore the safety and efficacy of individual tumor antigen-sensitized DC vaccine and their sensitized T cells in these solid cancers.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age:18-75 years
- •Pathologically diagnosed advanced (stage IV) malignant melanoma, bladder cancer or colorectal cancer with measurable lesions;
- •Failed in the previous standard therapy;
- •ECOG PS (Eastern Cooperative Oncology Group performance status) score 0-2 points;
- •The estimated survival period is ≥3 months;
- •Rehabilitate from previous therapy;
- •Adequate organ functions;
- •Patient's written informed consent;
排除标准
- •Tumor emergencies;
- •Abnormal coagulation function;
- •Contagious diseases, such as HIV, HBV, HCV infection;
- •Mental disorders;
- •Concomitant tumors;
- •Immunological co-morbidities
研究组 & 干预措施
Tumor antigen-sensitized vaccine and their sensitized T cells
Tumor antigen-sensitized vaccine is administrated, 1- week interval, totally 2 times.
Then, Neo-antigen DC vaccine and their sensitized T cells are administrated, 2-week interval, totally 5 times.
干预措施: Tumor antigen-sensitized DC vaccine and their sensitized T cells subcutaneous administration (Biological)
结局指标
主要结局
Number of participants with treatment-related adverse events as events as assessed by CTCAE v4.0
时间窗: 3 months after the last administration of cells
Number of participants with treatment-related adverse events as events as assessed by CTCAE v4.0
次要结局
- Number of participants with Overall survival as assessed by RECIST1.1(through study completion, an average of 1 year)
研究者
Zhen-Yu Ding
Professor
Sichuan University