A Clinical Trial to Evaluate the Safety of Autologous Tumor-infiltrating Lymphocytes(TILs) for the Treatment of Recurrent Ovarian Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Evaluation of cytotoxicity of cells against cancer cells
研究概览
简要总结
The objective of this clinical trial is to evaluate the safety of autologous tumor-infiltrating lymphocytes and to investigate their efficacy in recurrent ovarian cancer.
Participants undergo the following process:
There must be a cancerous lesion available for biopsy or surgery, and enhanced tumor-infiltrating lymphocytes are cultured from ovarian cancer tissue collected from the subject.
These are processed into human cells for administration and injected into the subject.
详细描述
Administer a fixed dose of CHA-TIL to the subject as a single intravenous infusion and evaluate safety and preliminary efficacy for 6 months.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Recurrent ovarian cancer
- •There is a cancerous lesion that can be removed by biopsy or surgery.
排除标准
- •Patient with immunodeficiency or autoimmune diseases that may be exacerbated by immunotherapy
- •Patient deemed unsuitable by the principal investigator
研究组 & 干预措施
autologous tumor-infiltrating lymphocytes(TILs) for the treatment
干预措施: autologous tumor-infiltrating lymphocytes (Other)
结局指标
主要结局
Evaluation of cytotoxicity of cells against cancer cells
时间窗: Treatment period- 2 months, follow-up- 4 months after completion of treatment
* Primary cancer cells isolated and cultured from a single cell of the same patient's tumor, or TIL cells cultured from the ovarian cancer cell line OVCAR3, are co-cultured in a CO2 incubator for 20 hours. After 20 hours, the cells are stained with 7AAD, and the cancer cell killing ability is analyzed using a flow cytometer * Measurement of IFN-γ secreted by T cells: CD8+ T cells inhibit tumor cell differentiation and enhance immune function by secreting IFN-γ. After co-culturing target cells and T cells, the pellet is used for cytotoxicity evaluation, and the culture medium is collected to measure the amount of secreted IFN-γ using ELISA. * Microscopic assay: After co-culturing fluorescently labeled primary cancer cells with fluorescently labeled enhanced T cells for 20 hours, the number of viable tumor cells is measured.
Evaluation of toxicity of protocol therapy including lymphodepletion, CHA-TIL, and high dose IL2
时间窗: Treatment periods 2 months, follow-up 4 months after completion of treatment
* Toxicity evaluation variables subject to analysis include adverse events, clinical laboratory test results (e.g., hematology, coagulation, serum analysis, and urinalysis), physical examination, and vital signs. Clinically significant changes from baseline will be summarized using descriptive statistics. The severity of adverse events will be graded according to CTCAE v5.0 and recorded in the case report form. * The overall frequency of adverse events (number of subjects and percentage), the worst reported severity, and the association with the investigational medicinal product will be recorded for each subject. * Serious adverse events are summarized in a similar manner. A list of deaths, SAEs, and AEs that lead to early termination or withdrawal from the clinical trial will also be provided. * For all AEs, a complete list will be presented including the subject number, clinical trial regimen, severity, severity, actions taken, outcome, association with the clinical trial treatment,
次要结局
未报告次要终点
研究者
Yong Wha Moon
Professor
CHA University