NCT06491225终止1 期
A Phase I, Open Label, Multicenter Study Evaluating the Safety and Efficacy of Autologous Tumor-Infiltrating Lymphocyte (GTE-001 Injection ) for Treatment of Patients With Advanced Lung Adenocarcinoma
Grit Biotechnology1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2024年7月18日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
This study is a Multiple centers, open design aimed at evaluating the safety,efficacy and Production feasibility of Autologous Tumor-Infiltrating Lymphocyte (GTE-001 injection ) for treatment of patients with Advanced lung adenocarcinoma,And evaluate potential biomarkers related to GTE-001 activity.
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 —（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 years old;
- •3. Advanced lung adenocarcinoma 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 ≥ 3 months;
- •6. Good function of vital organs;
- •7. At least one measurable target lesion that meets the definition of RECIST v1.1 after tumor sampling.
排除标准
- •1.Subject has previously received an allogeneic stem cell transplant or organ allograft,Subject has previously received engineered cell therapy,Prior FOLR1 directed therapy is not allowed unless it had been with an approved agent in the indication;
- •2.Subject has undergone surgery or received radiotherapy, immunotherapy, targeted therapy agents, anticancer vaccines, systemic steroids, or chemotherapy within 2 weeks of enrolment. Targeted agents, such as tyrosine kinase inhibitors, may be continued until 5 half-lives before enrolment;
- •3.Pregnant or lactating women; or women who are pregnant, breastfeeding, or planning to become pregnant within 12 months after cell infusion;
- •4.History of central nervous system (CNS) disorder,History of autoimmune disease,History of primary immunodeficiency;
研究组 & 干预措施
GTE001 injection treatment group
Experimental
干预措施: GTE001 injection (Biological)
结局指标
主要结局
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
研究者
研究点 (1)
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