NCT05949775尚未招募不适用
Clinical Study on the Treatment of Advanced Malignant Solid Tumors With the Combination of mRNA
Stemirna Therapeutics0 个研究点目标入组 20 人开始时间: 2023年7月20日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 主要终点
- progression-free survival (PFS)
研究概览
简要总结
This study is an open, single arm, dose increasing study to evaluate the safety and efficacy of the combination of mRNA personalized tumor vaccine encoding neoantigen (hereinafter referred to as tumor vaccine) and Sintilimab injection (hereinafter referred to as Sintilimab) in the treatment of advanced malignant solid tumors.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are ≥18 years old, without limitation of sex at time of consent.
- •Patients with malignant solid tumors confirmed by histopathology or cytology and having at least one measurable lesion.
- •Fresh biopsy specimens can be provided for vaccine preparation.
- •Patients with malignant solid tumors who develop secondary drug resistance after receiving PD-1/PD-L1 drug therapy, including but not limited to gastric cancer, esophageal cancer, and other gastrointestinal tumors of MSI-H
排除标准
- •It is known that it is allergic to any tumor vaccine and Sintilimab preparations; Or have experienced severe allergic reactions to other monoclonal antibodies in the past;
- •The predicted number of new antigens is less than 10;
- •Those who are pregnant or breastfeeding;
- •Those with an expected survival period of less than 3 months;
研究组 & 干预措施
single arm
Experimental
Neoantigen mRNA Personalised Cancer in combination with Stintilimab Injection. Participants will receive a total of 9 cycles of PCV every 21 days
干预措施: Neoantigen mRNA Personalised Cancer vaccine (Biological)
结局指标
主要结局
progression-free survival (PFS)
时间窗: Time Frame: from enrolling to patients disease progression，assessed up to 24 months
次要结局
未报告次要终点
研究者
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