Evaluating Safety and Quality of Life of Cancer Patients Treated by Autologous Immune Enhancement Therapy (AIET) in Vinmec International Hospitals
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of Adverse events and serious adverse events (AEs or SAEs)
研究概览
简要总结
This is a retrospective study that included 60 cancer patients who underwent autologous NK cell and CD8 T cell therapy between January 2016 and December 2021
详细描述
The dysfunction and reduced proliferation of peripheral immune cells including CD8 T and NK cells have been observed in both aging and cancer patients, thereby challenging the immune cell therapy in these subjects. Therefore, we evaluated the growth of these lymphocytes in elderly patients with several types of cancer and the correlation of peripheral blood (PB) indexes to the expansions. This is a retrospective study that included 60 cancer patients who underwent autologous NK cell and CD8 T cell therapy between January 2016 and December 2021. By optimizing the antiviral and tumor surveillance ability of both NK cells and CTLs through serial steps from isolation and expansion, followed by re-infusion of these activated cells back to the patient body, AIET has become a promising, cutting-edge method in detecting and eliminating cancer cells. The study aimed to evaluate the safety and effectiveness of 60 cancer patientsreceiving AIET.
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
- •Patients aged 18 - 75
- •Patients have been diagnosed with cancer.
- •Patients signed the written informed consent form.
排除标准
- •Severe health conditions such as serious infection, autoimmune diseases, or using any anti-rejection drugs
研究组 & 干预措施
autologous immune enhancement therapy (AIET) for treating cancer
A total of 60 cancer patients received one to seven sittings of natural killer (NK) cells and cytotoxic T lymphocytes (CTLs) infusions.
干预措施: Autologous immune enhancement therapy (AIET) for cancer patients (Combination Product)
结局指标
主要结局
Number of Adverse events and serious adverse events (AEs or SAEs)
时间窗: up to the 36-month period following treatment
the number of AEs or SAEs during and after Autologous Immune Enhancement Therapy (AIET)
次要结局
- Changes in health-related quality of life of patients(up to the 36-month period following treatment)
- Survival time of patients in this study(up to the 36-month period following treatment)
- Changes in Symptoms of patients using MD Anderson Symptoms Inventory Gastrointestinal Cancer Module (MDASI )(up to the 36-month period following treatment)