NCT02862028Unknown1 期
A Clinical Study of PD-1 Antibody Expressing CAR-T Cells for EGFR Family Member Positive Advanced Solid Tumor (Lung, Liver and Stomach)
Shanghai International Medical Center1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年8月1日最近更新:
适应症
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
- Objective response rate (ORR)
研究概览
简要总结
Objectives:
To evaluate the safety and effectiveness of cell therapy using herinCAR-PD1 cells to treat relapsed or refractory cancer.
Eligibility:
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 18~65 years old, male or female;
- •Life expectancy≥6 months;
- •ECOG score: 0-3;
- •Advanced solid tumor (lung cancer, gastric cancer, liver cancer) were diagnosed by pathological or clinical physicians;
- •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 IGFR1 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 x 10*/L, hemoglobin≥85g/L; lymphocyte count≥15%, total bilirubin≤100 mol/L; ALT and AST less than five 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 2 weeks following the cells transfusion.
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.
结局指标
主要结局
Objective response rate (ORR)
时间窗: 2 years
Progress-free survival(PFS)
时间窗: 2 years
Disease control rate,(DCR)
时间窗: 2 years
Overall survival
时间窗: 2 years
次要结局
- Quality of life(2 years)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
1 期
PD-1 Antibody Expressing CAR-T Cells for EGFR Family Member Positive Advanced Solid TumorPD-1 AntibodyCAR-T CellsAdvanced MalignanciesNCT02873390Ningbo Cancer Hospital20
Unknown
1 期
Anti-MUC1 CAR T Cells and PD-1 Knockout Engineered T Cells for NSCLCLung Neoplasm MalignantNon-small Cell Lung CancerNCT03525782The First Affiliated Hospital of Guangdong Pharmaceutical University60
已完成
1 期
PD-1 Knockout Anti-MUC1 CAR-T Cells in the Treatment of Advanced Breast CancerBreast Neoplasm Malignant FemaleAdvanced Breast CancerNCT05812326Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University15
招募中
1 期
Study of αPD1-MSLN-CAR T Cells to Evaluate the Safety, Tolerability, and Effectiveness for Patients With MSLN-positive Advanced Solid TumorsColorectal CancerNCT05089266Shanghai Cell Therapy Group Co.,Ltd30
招募中
1 期
PD-1 Silent PSMA/PSCA Targeted CAR-T for the Treatment of Prostate CancerProstate CancerNCT05732948Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd12