A Phase I Study to Evaluate the Safety and Efficacy of Autologous Immune Killer Cells in Patients With Late Stage Hepatocellular Carcinoma or Lung Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 主要终点
- Incidence of Treatment-Emergent Adverse Events [Safety]
研究概览
简要总结
This is a phase I clinical study. Blood is drawn from the patient and brought to our laboratory for isolation of immune cells. These immune cells are then proliferated over a two week period and used to produce our patented product IKC (Immune Killer Cells). The IKC will then infused back into the patient to treat the cancer. Each patient will receive a total of six infusions.
详细描述
This is a phase I clinical study. Blood is drawn from the patient and brought to our laboratory for isolation of immune cells. These immune cells are then proliferated over a two week period and used to produce the patented product IKC (Immune Killer Cells). The IKC will then infused back into the patient to treat the cancer. Each patient will receive a total of six infusions.
For each indication (cancer of the lung or liver) 10 patients are anticipated to be recruited, making a total of 20 subjects. All subjects will receive treatment as this is a single-arm study.
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
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •subjects had voluntarily given written informed consent
- •subjects had CT scan on lung or liver tumors within the past 4 weeks of the screening visit
- •subjects who were histologically or pathologically confirmed with locally advanced or metastatic lung cancer or HCC
- •subjects who did not have valid therapy, ever failed with other therapy, or refused or were not appropriate for other therapies for lung cancer or HCC
- •subjects' ECOG performance status ≤ 2
- •subjects with life expectancy ≥ 3 months
排除标准
- •subjects with medical history of gout
- •subjects who had participated other clinical trials within 4 weeks before the screening visit
- •subjects with positive result of HIV or HTLV test within 4 weeks before the screening visit
- •subjects with clinically significant diseases other than cancer
- •subjects with myocardial infraction, stroke, or congestive heart failure within 3 months before the screening visit
- •female subjects who were pregnant or lactating or women of child-bearing potential but unable to take adequate contraception
- •subjects with history of alcohol, drug or other substance abuse
- •subjects with disease of bacteremia
研究组 & 干预措施
Late stage lung cancer and liver cancer
Immune Killer Cells (IKC)
干预措施: Immune Killer Cells (IKC) (Biological)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events [Safety]
时间窗: 5 months
Adverse Events (AE) and Serious Adverse Events (SAE) will be recorded and evaluated for their relationship to the treatment
次要结局
- Response Evaluation Criteria in Solid Tumors (RECIST)(4 months)
- Quality of Life (QOL)(5 months)