A Clinical Research of CAR T Cells Targeting HER2 Positive Cancer
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Determine the toxicity profile of the HER2 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
研究概览
简要总结
Chimeric antigen receptor T cells (CAR-T) therapy has not yet been fully explored in solid tumors. Human epidermal growth factor receptor-2(HER2) is widely expressed in cancers. Investigators have developed anti-HER2 CAR-modified T cells and validated the efficiency targeting HER2-positive cancer in preclinical studies. This study is aimed to confirm its adverse effects including cytokine storm response and any other adverse effects. In addition, CAR-T cells persistence, tumor elimination and disease status after treatment will be evaluated.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Relapsed or refractory HER2 positive cancer.
- •Life expectancy>3 months.
- •Gender unlimited, age from 18 years to 80 years.
- •Assessable lesions with a minimum size of 10mm by CT scan or MRI.
- •Acceptable organ function
- •Hematology:
- •Absolute neutrophil count greater than 800/mm^3 without the support of filgrastim.
- •White blood cell (WBC) (> 2000/mm^3).
- •Platelet count greater than 50,000/mm^
- •Hemoglobin greater than 9.0 g/dl.
- •Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) less or equal to 3 times the upper limit of normal (patients without liver metastasis) or 6 times the upper limit of normal (patients with liver metastasis).
- •Serum creatinine less or equal to 3 times the upper limit of normal
- •Total bilirubin less than or equal to 3 times the upper limit of normal.
- •No other serious diseases(autoimmune disease, immunodeficiency etc.).
- •Adequate cardiac function(LVEF≥40%).
- •No other tumors.
- •Patients volunteer to participate in the research.
排除标准
- •Allergic to cytokines.
- •Uncontrolled active infection.
- •Acute or chronic GVHD.
- •Treated with T cell inhibitor.
- •HIV affected.
- •Other situations improper for the research.
结局指标
主要结局
Determine the toxicity profile of the HER2 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
时间窗: 3 years
Observe and handle the toxicity profile of the HER2 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
次要结局
- Efficacy of anti-HER2 CAR T cells to confirm the ability of CAR T cells to eliminate HER2 positive cancer cells(12 weeks)
- Maximum tolerated dose (MTD) of HER2 targeted CAR T cells(4 weeks)
- Survival time of Anti-HER2 CAR T cells in vivo.(1 year)
研究者
Zhi Yang
Researcher of Biotherpy Center
Southwest Hospital, China