A Single-arm Clinical Study of Autologous Tumor-Infiltrating Lymphocyte (GT307) for Treatment of Patients With Solid Tumours

Grit Biotechnology2 个研究点分布在 1 个国家目标入组 18 人2024年7月4日

适应症Adult

干预措施GT307 injection

概览

阶段: 不适用
干预措施: GT307 injection
疾病 / 适应症: Adult
发起方: Grit Biotechnology
入组人数: 18
试验地点: 2
主要终点: Incidence and severity of adcersed events per CTCAE 5.0
状态: 招募中
最后更新: 18天前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

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).

注册库

clinicaltrials.gov

开始日期

2024年7月4日

结束日期

2027年6月6日

最后更新

18天前

研究类型

Interventional

研究设计

Single Group

性别

All

研究者

发起方

Grit Biotechnology

责任方

Sponsor

入排标准

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

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