Test of CD47-SIRPα Inhibitors on the Immune Microenvironment Colon Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Establishment of patient derived organoids (minimum n=30) resembling the primary tissue sample
研究概览
简要总结
Our goal is to create novel CD47-SIRPα inhibitors using small molecules to reverse TAM-mediated immune suppression and restore anti-tumor immunity in CRCs. Our program uses structure-based drug design to create selective and potent small molecule inhibitors of SIRPα-CD47 to target the tumor microenvironment with greater efficacy and lower toxicity than CD47-targeting antibodies. .
In order to study the activity of CD47-SIRPα inhibitors on the immune microenvironment of tumors, we propose to use organoids derived from biopsies of patients with colon cancer. Tumoroids preserve the patient's tumor stroma (including myeloid cells) and provide an accurate in vitro model of complex tumor immune interaction for the evaluation of immunotherapies.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Patient over 18 years old
- •Patient who has signed a consent to participate;
- •Patient with metastatic or non-metastatic colon cancer, or recurrence of colon cancer for whom excision surgery has been proposed;
- •Patient affiliated to a social security scheme, or beneficiary of such a scheme
排除标准
- •Patient who had emergency colon cancer surgery
- •Person in an emergency situation or unable to express their consent.
- •Adult subject to a legal protection measure (adult under guardianship, curatorship or safeguard of justice),
- •Patient unable to submit to the medical follow-up of the trial for geographical, social or psychological reasons
结局指标
主要结局
Establishment of patient derived organoids (minimum n=30) resembling the primary tissue sample
时间窗: 18 months from study launch
the capacity to establish patient-derived organoids from tumor and adjacent normal tissue will be evaluated using a histology score evaluating and comparing primary and organoid sample characteristics.
次要结局
- Establishment of a validated cryobank of patient derived organoids (minimum n=30)(18 months from study launch)
- To assess the effect of immunotherapy on the antitumor activity of autologous T cells from peripheral blood samples using tumor viability measurements (cell titer glo, FACS)(48 month)
- Generate a T cell biobank by FACS isolating T cells using the CD3 surface marker directed against the human form(48 month)