A Phase I/Ⅱ Open, Single Center, One-armed Trail, Neo - MASCT Treatment for Advanced NSCLC of the Safety and Efficacy.
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
研究概览
简要总结
Neoantigen （Neo）is a new targets for immune cells，that the DC neoantigen immunotherapy was more effective in triggering specific T-cell responses. Neo-MASCT using the DC vaccine and neoantigen T cells .Dendritic cells(DC) was induced from autologous peripheral blood，and be loaded with antigens and re-infused. In vitro, antigen-pulsed DC can stimulate autologous T-cell proliferation and induction of autologous specific cytotoxic T-cells(CTL)，similarly re-infused.
The study is aimed to evaluate the safety of Neo-MASCT in patients with advanced NSCLC.
详细描述
This study is divided into two stages. The first stage is the safety study in small samples, and the second stage is the sample size expansion phase.
20 failed standard treatment patients with advanced or recurrent NSCLC will be recruited .
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
盲法说明
Open clinical study
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The age is 18 to 80 years old.
- •The failure standard treatment subjects with advanced or relapsed NSCLC.
- •Informed consent of the patient/legal representative was signed.
- •Other anti-cancer treatments are at least one month apart from the study .
- •The eastern cancer cooperative group (ECOG) was rated 0-
- •According to the The reaction of solid tumors v1.1 (RECIST1.1 standard), there must be at least one measurable lesion .
- •The baseline blood and biochemical targets met the following criteria: The hemoglobin ≧ 85g/L ;White blood cells ≧ 3.0 x10 ^ 9 / L;Platelet ≧ 50 x10 ^ 9 / L;alanine aminotransferase (ALT), serum aspartate transaminase(AST) ≦ 2.5 times normal value limit; For patients with live metastases, ALT and AST are five times the normal limit; The alkaline phosphatase(ALP) ≦ 2.5 times the normal value; Serum bilirubin less than 1.5 times the normal value limit;
排除标准
- •Participate in the planning or implementation of the research .
- •In addition to other clinical studies, unless it is an observational clinical study .
- •Being pregnant or planning a pregnancy.
- •Refuse to provide a blood specimen .
- •Allergic to sodium hydroquinone .
- •There is a history of organ transplantation
- •Brain transfer of the active period
- •Immunosuppressant drugs are currently in use or within 14 days prior to treatment.
- •The following exceptions are:Nasal, inhaled, topical use of steroid, or topical steroids (such as interjoint injection) .
- •Use a corticosteroid, no more than 10mg/day of prednisolone or its equivalent .
- •The use of steroids as a preventative treatment for hypersensitivity (such as CT scans) .
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
时间窗: 1 to 2 years
The incidence of treatment-related adverse events were graded with the use of the National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.03
次要结局
- Clinical response of treatment according to RESIST v1.1 criteria(1 to 2 years)
- Disease Control Rate (DCR) based on RESIST v1.1 criteria.(1 to 2 years)
- Overall Survival (OS) based on RESIST v1.1 criteria.(From enrollment to death of patients)
- Elispot report(1 to 2 years)
- Progression-Free Survival (PFS) based on RESIST v1.1 criteria.(From enrollment to progression of disease. Estimated about 6 months)