A Multi-center,Single-arm Phase I/II Clinical Study of Autologous Tumor-infiltrating Lymphocyte Injection (GT201) for Advanced Solid Tumors
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 3
- 主要终点
- Incidence and severity of adcersed events per CTCAE 5.0
研究概览
简要总结
This study is a multi-center, single-arm phase I clinical trial. A total of 26~42 subjects (20 evaluable cases are expected) from 1 cohort will be enrolled in this study.
An "autologous tumor-infiltrating lymphocyte therapy" dosing regimen consisting of lymphodepleting chemotherapy (FC regimen: cyclophosphamide + fludarabine), infusion of autologous tumor-infiltrating lymphocyte injection, and interleukin-2 injection will be used.The study process is divided into: screening period, sampling and production period, clearing and chemotherapy period, treatment and observation period, and follow-up period
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
- All
- 接受健康志愿者
- 否
入选标准
- •1.Voluntarily enrolled in the study, signed an informed consent form, and willing and able to comply with the study protocol.
- •2.At least one lesion (preferably superficial lymph nodes) that has not been treated with radiation, has not received other local therapies, has access to tumor tissue, and can isolate at least a mass ≥ 1.0 g of tissue mass (either single lesion source or multiple lesions combined) for the preparation of autologous tumor-infiltrating lymphocytes.
- •3.Eastern Collaborative Oncology Group (ECOG) physical fitness status score of 0 or 1.
排除标准
- •1.Failure of surgery and/or radiation therapy to relieve spinal cord compression is not eligible for enrollment.
- •2.People with uncontrolled tumor-related pain as judged by the investigator. 3.Risk of major bleeding as assessed by investigators. 4.Have interstitial pneumonia or clinically significant active pneumonia at screening, or other respiratory disease that severely affects lung function.
- •5.Any active autoimmune disease 14 days prior to clear lymphatic chemotherapy, history of autoimmune disease, or disease requiring systemic steroid hormone or immunosuppressive drug therapy .
- •6.History of allergic reaction to any component of the drugs to be used in the study (including but not limited to autologous tumor infiltrating lymphocytes, cyclophosphamide, fludarabine, interleukin-2, dimethyl sulfoxide (DMSO), human serum albumin (HSA), dextran-40, antibiotics (beta-lactam antibiotics, gentamicin)); 7.Women who are pregnant or breastfeeding;
研究组 & 干预措施
GT201 treatment group
Autologous tumor infiltrating lymphocyte injection
干预措施: GT201 (Biological)
结局指标
主要结局
Incidence and severity of adcersed events per CTCAE 5.0
时间窗: 3 years
To characterize the safety profile of autologous TIL injection（GT201) in patients with relapsed/metastatic advanced solid tumor as measured by the incidence and severity of adcersed events per CTCAE 5.0
次要结局
- Objective response rate(3 years)
- Progression-free survival(3 years)
- Overall survival(3 years)