A Single-arm Clinical Study of Autologous Tumor-Infiltrating Lymphocyte (GT307) for Treatment of Patients With Solid Tumours
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 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 single arm, open design aimed at evaluating the safety and tolerability of Autologous Tumor-Infiltrating Lymphocyte (GT307) for treatment of patients with solid tumours,while evaluating pharmacokinetic characteristics and efficacy assessment to determine the optimal biological dose (OBD).
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 join the study, signed informed consent form， willing and able to comply with the study protocol;
- •2. Age 18 to 70 years old;
- •3. Ovarian cancer that progresses after recurrence or first-line chemotherapy；
- •4. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
- •5. Expected survival time of ≥ 12 weeks;
- •6. Good function of vital organs;
- •7. Subjects entering this study due to disease progression must have an imaging record of disease progression before tumor sampling;
- •8. At least one measurable target lesion that meets the definition of RECIST v1.1 after tumor sampling.
排除标准
- •1.Patients with uncontrollable tumor-related pain as judged by the investigator; participants requiring analgesic medication must already have a stable analgesic regimen at the time of study entry; symptomatic lesions suitable for palliative radiotherapy should be completed prior to study entry;
- •2.Known mental illness, alcoholism, drug use or substance abuse;
- •3.Pregnant or lactating women; or women who are pregnant, breastfeeding, or planning to become pregnant within 1 year after cell infusion;
- •4.Those who have received other clinical trial drug treatment within 4 weeks before preconditioning by lymphodepletion,plan to participate in other clinical trial drug treatment during the study;
- •5.The investigators determine that other conditions that make the patient not suitable for enrollment.
研究组 & 干预措施
GT307 injection treatment group
干预措施: GT307 injection (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（GT307) in patients with relapsed/metastatic advanced solid tumor as measured by the incidence and severity of adcersed events per CTCAE 5.0
Objective response rate
时间窗: 3 years
To evaluate efficacy parameters such Objective Response Rate (ORR) per RECIST 1.1, as assessed by the Investigator
次要结局
未报告次要终点