NCT04557306已完成1 期
An Open, 3+3 Design With Dose De-escalation, Single-center, Phase 1 Trial to Evaluate Tolerabiility and Safety of Intravenously Administered CBT101, an Autologous Natural Killer Cell, in Patients Who Underwent Curative Surgery and Adjuvant Therapy for Solid Cancer
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Dose limiting toxicity (DLT)
研究概览
简要总结
The objective of the study is to evaluate tolerability and safety of CBT101 in patients who underwent curative surgery and adjuvant therapy for solid cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female adults aged 19 years and older
- •Patients with solid tumors as below (1) histologically or cytologically confirmed solid tumors (2) 4 - 12 weeks of last adjuvant therapy after radical operations and adjuvant therapy
- •Life expectancy 6 months
- •Eastern Cooperative Oncology Group perfornace status (ECOG PS) 0-1
排除标准
- •History of leptomeningeal carcinomatosis or spinal cord compression
- •History of peritoneal carninomatosis
- •Hemoglobine less than 9.0g/dL
- •Absolute Neutrophil Count (ANC) less than 1.5x10^3/mm^3
- •Platelet count less than 75x10^9/L
- •Total bilitbinn grater than 1.5 times te upper limit of normal
- •Alanine amino transferase (ALT) greater than 3 times the upper limit of normal
- •Alanine phospatase (ALP) greater than 2.5 times the upper limit of normal
- •Uncontrolled hypertension
- •Intensive insuline therapy
- •Active infectious disease
- •Patients with hypersensitivity history or allergy to investigational product
- •Pregmant of lactating woman
- •Patients who have participated in another clinical trials witin 30 days before the start of this clinical trial
- •Patients judged to be inappropriate for this study by the investigator with other reasons
结局指标
主要结局
Dose limiting toxicity (DLT)
时间窗: 29 days
Dose limiting toxicity (DLT)
次要结局
- Oerall survival rate (OS)(6 months)
- Disease-free survival rate (DFS)(6 months)
研究者
研究点 (2)
Loading locations...
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