NCT02873390Unknown1 期
A Clinical Study of PD-1 Antibody Expressing CAR-T Cells for EGFR Family Member Positive Advanced Solid Tumor
适应症
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
To evaluate the safety and effectiveness of cell therapy using herinCAR-PD1 cells to treat advanced cancer.
Individuals greater than or equal to 18 years of age and less than or equal to 70 years of age who have been diagnosed with relapsed or refractory cancer that has not responded to or has relapsed after standard treatment.
详细描述
A total of 20 patients may be enrolled over a period of 1-2 years.
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
- •Age 18~80 years old, male or female;
- •Life expectancy≥6 months;
- •ECOG score: 0-2;
- •Advanced Solid Tumor were diagnosed by histology and cytology;
- •Enough venous channel,no other contraindications to the separation and collection of white blood cells;
- •Immunohistochemistry and RT-PCR technology will be used to determine the positive EGFR family (including EGFR, HER2, HER4) and EGFRVIII、IGF1R protein. At least one protein expressed in immunohistochemical tumor tissue should be no less than grade 2 or 2+ scores. The levels of protein are defined as follows: (according to cell staining) : grade 0: without staining; grade 1: 1-25%; grade 2: 26-50% and grade 3: 51-100%; (According to the intensity): negative; 1+; 2+ and 3+;
- •Laboratory examination: white blood cell≥3 x 10*9/L, blood platelet count≥60 x10*9/L, hemoglobin≥85g/L; lymphocyte ≥0.7×109/L, total bilirubin less than 2.5 times of the normal level; ALT and AST less than 2.5 times of the normal level; serum creatinine less than 1.5 times of the normal level；
- •Signed informed consent；
- •Women of child-bearing age must have evidence of negative pregnancy test and be willing to practice birth control after 4 months following the cells transfusion.
- •Disease progression and the current treatment is invalid.
- •The treatment effect is not ideal after receiving 2 line therapy at least and willing to join in clinical trials
排除标准
- •Expected Overall survival < 6 months;
- •Patients with uncontrolled hypertension,unstable coronary disease (uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (> Class II, NYHA), or myocardial infarction within 6 months.
- •Abnormal lung function: FEV (forced expiratory volume) < 30% prediction, DLCO (diffusing capacity of the lung for carbon monoxide) < 30% prediction, blood oxygen saturation < 90%;
- •Other serious diseases: nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc;
- •Unable or unwilling to provide informed consent, or fail to comply with the test requirements.
- •Uncontrolled active infection.
- •Serious chronic disease of critical organs such as kidney and liver. Kidney function more than CKD stage I,and liver function less than the Child - Pugh class B;
- •Long-term use or being used of immunosuppressive drugs with autoimmune diseases
- •Glucocorticoid is needed in a long term.
- •Currently (within 30 days) enrolled in another clinical trial.
- •Pregnancy or breastfeeding women.
结局指标
主要结局
Overall survival
时间窗: 2 years
Progress-free survival(PFS)
时间窗: 2 years
Disease control rate,(DCR)
时间窗: 2 years
Objective response rate (ORR)
时间窗: 2 years
次要结局
- Quality of life(2 years)
研究者
研究点 (1)
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