NCT03941457Unknown1 期
Clinical Research of ROBO1 Specific BiCAR-NK Cells on Patients With Pancreatic Cancer
Asclepius Technology Company Group (Suzhou) Co., Ltd.1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2019年5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
- 9
- 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 treatment of solid tumors. This study is for evaluation of the safety and efficacy of ROBO1 CAR-NK cell immunotherapy for pancreatic cancer.
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
- •Histologically confirmed metastatic pancreatic adenocarcinoma
- •Patients aged between 18 and 75
- •ROBO1 expression in malignancy tissues detected by immuno-histochemistry (IHC)
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Life expectancy greater than 3 months
- •Subjects must have measurable disease as defined by RECIST 1.1 criteria
- •Satisfactory organ and bone marrow function: White blood cell count (WBC) ≥ 3.0×10^9/L, Platelets ≥ 70×10^9/L, Hb ≥ 9.0g/dL, lymphocyte (LY) ≥ 0.7×10^9/L, LY% ≥ 15%, Alb ≥ 2.8g/dL, serum lipase and amylase < 1.5 × upper limit of normal, serum creatinine ≤ 2.5mg/dL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5×upper limit of normal, serum total bilirubin ≤ 2.0mg/dL. These tests must be conducted within 7 days prior to registration
- •Karnofsky score ≥ 60
- •Ability to give informed consent
排除标准
- •Previously treated with any gene therapy products
- •Patients who are receiving any other investigational agents
- •Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the treatment on the fetus or infant
- •Active systemic infections (e.g.: requiring anti-infective treatment), coagulation disorders or any other major medical illnesses
- •Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease)
- •Concurrent opportunistic infections
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
研究者
研究点 (1)
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