NCT07621471尚未招募1 期
A Single-Arm Clinical Study of IL-15 Enhanced Engineered NK Cells for Refractory Relapsed/Metastatic Solid Tumors
Genovn Therapeutics (Suzhou) Co., Ltd.1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2026年7月1日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
- 试验地点
- 1
研究概览
简要总结
A single-arm, Phase 1 study evaluating safety, tolerability, and preliminary efficacy of IL-15 enhanced engineered NK cells in patients with refractory relapsed or metastatic 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
- •Age 18-70 years;
- •histopathologically confirmed metastatic or recurrent solid tumors (breast, liver, lung, etc.);
- •failed prior standard therapy;
- •>=1 measurable lesion per RECIST 1.1;
- •adequate bone marrow, liver, kidney, and coagulation function;
- •recovered from prior treatment toxicities;
- •signed informed consent.
排除标准
- •Pregnancy/lactation;
- •other malignancy within 5 years (except cured localized tumors);
- •active autoimmune disease or immunodeficiency;
- •uncontrolled cardiovascular disease or infection;
- •positive HBsAg/HBcAb or HCV antibody (unless viral load undetectable);
- •positive syphilis antibody;
- •major surgery or vaccination within 28 days;
- •prior cell therapy;
- •severe allergy to study drugs;
- •investigator judged unsuitable.
研究者
研究点 (1)
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