Anti-cancer Neoantigen Polypeptide Vaccine to Treat Advanced Solid Tumors: Phase I Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of Patients with Dose Limiting Toxicity
研究概览
简要总结
The WES and RAN-seq will be performed to identify and verify neoantigens and appropriate polypeptide sequences will be verified, manufactured and protected for vaccine production by multiple in vitro and in vivo studies. Clinical studies will be performed to test anti-cancer function of the polypeptide vaccine for immunotherapy of human cancer patients. In this phase I study, the safety, tolerance, and preliminary efficacy of the polypeptide vaccine immunotherapy on human cancers will firstly be evaluated.
详细描述
- Choose appropriate patients with advanced solid cancers, with written consent for this study;
- Perform biopsy to get fresh sample for DNA/RNA-seqencings and bioinformatics analysis;
- Produce appropriate polypeptide vaccine for human use and deliver the vaccine into selected patients via local injections, and follow up closely to collect related results as required;
- To enhance the killing capability, cotreatment the patients with PD1/PDL1/CTLA4 antibodies may be applied;
- Evaluate the clinical results as needed.
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
- •1. Patients with advanced cancer;
- •Life expectancy >12 weeks;
- •Adequate heart, lung, liver, kidney, and blood function;
- •Available high quality vaccine for human use;
- •Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.
排除标准
- •Had accepted gene therapy before;
- •Severe virus infection such as HBV, HCV, HIV, et al;
- •Known HIV positivity;
- •Active infectious disease related to bacteria, virus,fungi,et al;
- •Other severe diseases that the investigators consider not appropriate;
- •Pregnant or lactating women;
- •Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day);
- •Other conditions that the investigators consider not appropriate.
结局指标
主要结局
Number of Patients with Dose Limiting Toxicity
时间窗: Six months
A dose limiting toxicity is defined as any toxicity that is considered to be primarily related to the vaccine, which is irreversible, or life threatening or hematologic or non-hematologic Grade 3-5.
次要结局
- Percent of Patients with best response as either complete remission or partial remission.(Six months)