NCT06954558招募中1 期
The Phase I, Open-label, Single-arm Clinical Study Evaluating the Safety, Pharmacokinetics, and Preliminary Efficacy of GK01 Cell Injection in Patients With Advanced Solid Tumors
Tianjin Medical University Cancer Institute and Hospital1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2025年3月18日最近更新:
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Safety and Tolerability
研究概览
简要总结
This study is a Phase I, open-label, single-arm clinical trial to evaluate the safety, pharmacokinetics, and preliminary efficacy of GK01 in patients with advanced solid tumors.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
GK01 injection
Experimental
Autologous tumor-reactive T cells injection
干预措施: GK01 Injection (Drug)
结局指标
主要结局
Safety and Tolerability
时间窗: 2 years
The incidence and severity, and correlation of AEs (Adverse Events) and SAEs (Serious Adverse Events).
次要结局
- PK(2 years)
- Objective response rate (ORR)(2 years)
- Progress-free survival(PFS)(2 years)
- Overall survival (OS )(2 years)
- Disease control rate (DCR)(2 years)
- Patient Quality of Life(2 years)
- PD marker(2 years)
研究者
研究点 (1)
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