Clinical Research of ROBO1 Specific BiCAR-NK/T Cells on Patients With Malignant Tumor
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
- Occurrence of treatment related adverse events as assessed by CTCAE v4.03
研究概览
简要总结
Immunotherapy has become the major breakthrough and the most promising treatment, with the host of development of tumor biology, molecular biology and immunology. ROBO1 is a potential target and spectacular paradigm in the diagnosis and treatment of solid tumors. This study is for evaluation of the safety and efficacy of ROBO1 CAR-NK/T cell immunotherapy for 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18~75 years old, male or female
- •Life expectancy ≥ 6 months
- •ECOG score: 0-3
- •ROBO1 expression in malignancy tissues detected by immuno-histochemistry (IHC)
- •Advanced solid tumor was diagnosed by pathological or clinical physicians
- •Laboratory examination: white blood cell≥3 x 10*9/L, blood platelet count≥70 x 10*9/L, hemoglobin≥80g/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 cell 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
研究组 & 干预措施
anti-tumor response of BiCAR-NK/T cells (ROBO1 CAR-NK/T cells)
Patients with relapsed and refractory cancer of ROBO1 expression will be treated with BiCAR-NK/T cells (ROBO1 CAR-NK/T cells).
干预措施: BiCAR-NK/T cells (ROBO1 CAR-NK/T cells) (Biological)
结局指标
主要结局
Occurrence of treatment related adverse events as assessed by CTCAE v4.03
时间窗: 1 year
Defined as \>= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment.
次要结局
未报告次要终点