简要介绍
这是一项分期未标注的注册临床试验,评估自体TIL(肿瘤浸润淋巴细胞)治疗卵巢癌的安全性、可行性及初步疗效。当前状态:招募中。计划入组 6 例。试验地点:韩国 · 京畿道(共 1 个中心)。登记号:NCT07651124。
入组条件决定能不能参加
仅女性 · ≥ 20 Years
纳入标准:
• 复发性卵巢癌。
• 有可通过活检或手术切除的癌性病灶。
排除标准:
• 患有可能因免疫治疗而加重的免疫缺陷或自身免疫性疾病。
• 主要研究者判定不适合参加。
核对登记原文(英文)
Inclusion Criteria:
* Recurrent ovarian cancer
* There is a cancerous lesion that can be removed by biopsy or surgery.
Exclusion Criteria:
* Patient with immunodeficiency or autoimmune diseases that may be exacerbated by immunotherapy
* Patient deemed unsuitable by the principal investigator
以上为辅助阅读译文。是否适合入组须由主治医生判断,最终以登记平台与研究者确认为准。
研究终点衡量什么算有效
- 主要终点评估细胞对癌细胞的细胞毒作用治疗期2个月;治疗结束后随访4个月
- 主要终点评估包括淋巴细胞清除、CHA-TIL和大剂量IL-2在内的方案治疗毒性治疗期2个月;治疗结束后随访4个月
核对登记原文(英文)
主要终点:Evaluation of cytotoxicity of cells against cancer cells · * 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. · Treatment period- 2 months, follow-up- 4 months after completion of treatment;Evaluation of toxicity of protocol therapy including lymphodepletion, CHA-TIL, and high dose IL2 · * 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, · Treatment periods 2 months, follow-up 4 months after completion of treatment
研究设计怎么做的
- 研究类型
- 干预性研究
- 入组人数
- 6 人(预计)
- 分组方式
- 不适用(单臂)
核对分组登记原文(英文)
- autologous tumor-infiltrating lymphocytes(TILs) for the treatment · OTHER
关键日期
- 开始日期
- 2025-04-01
- 主要完成日期
- 2026-12-31
- 全部完成日期
- 2027-06-30
- 登记状态核实于
- 2026-06
联系与责任方
- 主要研究者
- Yong Wha Moon
- 申办方
- Yong Wha Moon
- 联系邮箱
- ymoon@cha.ac.kr
- 联系电话
- 82-31-780-3436
登记简述
本临床试验旨在评估自体肿瘤浸润淋巴细胞的安全性,并研究其治疗复发性卵巢癌的疗效。
患者须有可供活检或手术切除的癌性病灶,从采集的卵巢癌组织中培养扩增增强型肿瘤浸润淋巴细胞,制备为供人体使用的细胞后再注射给患者。
核对登记原文(英文)
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.