NCT05007379招募中不适用
Cohort Study to Determine the Antitumor Activity of New CAR-macrophages in Breast Cancer Patients' Derived Organoids (CARMA)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Antitumor activity of the CAR-macrophages compared to non-modified macrophages
研究概览
简要总结
Cell-based immune therapy using modified macrophages is a promising therapeutic approach in breast cancer. The objective of this cohort study is to collect tumor samples to develop patients' derived organoids to test the antitumor activity of newly developed CAR-macrophages. Other biological samples will be collected such as blood to analyze the host inflammatory status.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 18 years or more
- •Histologically confirmed breast cancer at any stage
- •Requiring surgery or tumor biopsy as standard of care
- •Any or no systemic treatment
- •Signed informaed consent
- •Health insurance coverage
排除标准
- •Opposed to biospecimen collection
结局指标
主要结局
Antitumor activity of the CAR-macrophages compared to non-modified macrophages
时间窗: 24 months
Measurement of the phagocytic capacity
Antitumor activity of the CAR-macrophages against organoids from HER2 negative, HER2 low and HER2 positive breast cancers
时间窗: 24 months
Measurement of the phagocytic capacity
次要结局
- Antitumor activity of the CAR-macrophages against organoids from early and advanced breast cancers patients(24 months)
研究者
研究点 (1)
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