A Phase I Study of Autologous Killer Cell Injection Induced by Dendritic Dells Loaded With 6B11 Anti-idiotype Minibody (6b11 - OCIK Injection) Treatment in Patients With Recurrent Drug-resistant Ovarian Cancer
试验速览
- 阶段
- 1 期
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- MTD
研究概览
简要总结
This is an open, single-arm, phase I clinical trial to evaluate safety and efficacy and of 6b11-OCIK injection in the treatment of recurrent drug-resistant ovarian cancer
详细描述
This is a phase I clinical trial of cytotoxic T cell injection induced by dendritic cells loaded with 6B11 anti-idiotype minibody (6b11-OCIK injection) for recurrent drug-resistant ovarian cancer. Main purpose of this research is to determine the maximum tolerable dose (MTD) of 6B11-OCIK injection in the treatment of patients with ovarian cancer. Moreover, secondary purpose is to evaluate the effect of 6B11-OCIK injection on the immune system of patients, the efficacy of autologous 6B11-OCIK injection in the treatment of patients with ovarian cancer obtain and the correlation between OC166-9 antigen expression and efficacy of 6B11-OCIK injection. Thirdly, exploratory purpose is to evaluate the effect of 6B11-OCIK injection on laboratory examination.
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
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
6B11-OCIK injection
干预措施: 6B11-OCIK Injection (Drug)
6B11-OCIK injection
干预措施: Doxorubicin (Drug)
结局指标
主要结局
MTD
时间窗: 1 year
Determine the maximum tolerable dose (MTD) of 6B11-OCIK injection in the treatment of patients with ovarian cancer base on the AE, SAE and laboratory examination.
次要结局
- Objective response rate (ORR)(3 years)
- Changes of the cell immunophenotype(1 year)
- Changes of the C-reactive protein (CRP)(1 year)
- Changes of the interleukin-6 (IL-6)(1 year)
- Changes of the immunoglobulin(1 year)
- Changes of the antinuclear antibody (ANA)(1 year)
- Disease control rate (DCR)(3 years)
- Progression Free Survival (PFS)(3 years)
- Correlation between OC166-9 antigen expression and efficacy of 6B11-OCIK injection.(1 year)
研究者
Changxiaohong
Director of Gynaecologic Oncology Center
Peking University People's Hospital