NCT02930993Unknown1 期
A Safety and Efficacy Study of Autologous T Cells Engineered to Express Chimeric Antigen Receptor Targeting Mesothelin in Patients With Recurred or Metastatic Malignant Tumors
China Meitan General Hospital2 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
- 2
- 主要终点
- safety of infusion of autologous anti-mesothelin CAR T cells as assessed by the incidents of treatment related adverse events per NCI CTCAE V4.0
研究概览
简要总结
This is a single-arm, open-label, one center, dose escalation clinical study, to determine the safety and efficacy of infusion of autologous T cells engineered to express chimeric antigen receptor targeting mesothelin in adult patients with mesothelin positive, recurrent or metastatic malignant 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with mesothelin positive, recurrent or metastatic malignant tumors , including but not limited to pancreatic adenocarcinoma, ovarian cancer, or pleural mesothelioma.
- •relapsed or metastatic after standard treatment
- •measurable tumors by RECIST1.1 standard
- •patients are 18 to 70 years old.
- •life expectancy > 3months.
- •satisfactory major organ functions: adequate heart function with LVEF≥50%; no obvious abnormities in ECG; pulse oximetry ≥ 90%; cockcroft-gault creatinine clearance≥40 ml/min; alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3ULN; Bilirubin ≤2.0 mg/dl .
- •Blood: Hgb ≥ 80 g/L, ANC ≥ 1×10^9/L, PLT ≥ 50×10^9/L.
- •women of reproductive potential must have a negative pregnancy test. Male and female of reproductive potential must agree to use birth control during the study and one year post study.
排除标准
- •patients with a prior history of autoimmune disease or other diseases who need long-term use of systemic hormone drug or immunosuppressive therapy
- •active infection.
- •HIV positive.
- •active hepatitis B virus infection or hepatitis C virus infection.
- •currently enrolled in other study.
- •patients, in the opinion of investigators, may not be eligible or are not able to comply with the study.
- •patients who have allergic disease, or are allergic to T cell products or other biological agents used in the study.
- •patients whose tumors have metastasized to bone marrow, or have clinical signs of bone metastasis, such as bone and joint pain .
- •patients who have brain metastasis or signs of brain metastasis, such as loss of self-consciousness.
结局指标
主要结局
safety of infusion of autologous anti-mesothelin CAR T cells as assessed by the incidents of treatment related adverse events per NCI CTCAE V4.0
时间窗: 2 years
incidents of treatment related adverse events per NCI CTCAE V4.0
次要结局
- activation of anti-mesothelin CAR T cells in patients(6 months)
- persistence of anti-mesothelin CAR T cells in patients(1 year)
- treatment response rate of anti-mesothelin CAR T cells(4 weeks)
- overall survival(2 years)
- proliferation of anti-mesothelin CAR T cells in patients(6 months)
- progression free survival(6 months)
研究者
Jinwen Sun
director of Department of General Surgery and Surgical Oncology
China Meitan General Hospital
研究点 (2)
Loading locations...
相似试验
Unknown
1 期
Autologous CD19 CAR T Cells in Relapsed or Refractory B-cell LymphomaB-cell LymphomaNCT02842138Peking University25
招募中
1 期
A Study of CD19 Targeted CAR T Cell Therapy in Pediatric Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia (B ALL) and Aggressive Mature B-cell Non-Hodgkin Lymphoma (B NHL)Relapsed or Refractory B Cell Acute Lymphoblastic LeukemiaRelapsed or Refractory B Cell Non-Hodgkin LymphomaNCT06173518Autolus Limited30
Unknown
不适用
Clinical Study of Redirected Autologous T Cells With a Chimeric Antigen Receptor in Patients With Malignant TumorsB Cell LymphomaB Cell LeukemiaMyelomaPancreatic CarcinomaAdenocarcinoma of Esophagogastric JunctionHepatocellular CarcinomaNCT03302403Kang YU18
Unknown
1 期
Clinical Study of CAR-BCMA T in Patients With Refractory or Relapsed Multiple MyelomaRefractory or Relapsed Multiple MyelomaNCT03716856First Affiliated Hospital of Zhejiang University11
Unknown
不适用
Clinical Study of CAR-BCMA T Cells in Patients With Refractory or Relapsed Multiple MyelomaRefractory or Relapsed Multiple MyelomaNCT03380039Xinhua Hospital, Shanghai Jiao Tong University School of Medicine6