NCT02930967Unknown1 期
A Safety and Efficacy Study of Chimeric Switch Receptor Modified T Cells in Patients With Recurrent 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 as assessed by incidents of treatment related adverse events as assessed by CTCAE V4.0.
研究概览
简要总结
A Chimeric Switch Receptor, which was constructed by fusing the PD1 extracellular ligand binding domain to the CD28 intracellular costimulatory domain, was designed to target PD-L 1 positive tumors . In this single-arm, open-label, one center, dose escalation clinical study, the main purpose is to determine the safety and efficacy of infusion of autologous Chimeric Switch Receptor modified T cells (CSR T) in adult patients with PD-L1 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 PD-L1 positive, recurrent or metastatic malignant tumors , including but not limited to pancreatic cancer, renal cancer, colorectal cancer, lymphoma, breast cancer and lung cancer;
- •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 with allergic disease, or are allergic to T cell products or other biological agents used in the study.
- •patients whose tumors have metastasized to bone, or have clinical signs of bone metastasis, such as bone and joint pain.
- •patients with brain metastasis, or have clinical signs of brain metastasis, such as loss of self-consciousness.
结局指标
主要结局
Safety as assessed by incidents of treatment related adverse events as assessed by CTCAE V4.0.
时间窗: 2 years
safety of infusion of autologous CSR T cells with cyclophosphamide as lymphodepleting chemotherapy
次要结局
- progression-free survival(6 months)
- proliferation of CSR T cells in patients(2 years)
- Persistence of CSR T cells in patients(2 years)
- treatment response rate of CSR T cell infusion(4 weeks)
- overall survival rate(2 years)
研究者
Jinwen Sun
Director of Department of General Surgery and Surgical Oncology
China Meitan General Hospital
研究点 (2)
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