Personalizing Adoptive Cell Transfer for Solid Tumors: Towards a New Patient-tailored Treatment Option
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 主要终点
- Frequency and cytotoxic activity of patient-specific tumor-reactive T cells.
研究概览
简要总结
This is a monocentric prospective observational study. This study will include patients with a diagnosis of non-small cell lung cancer for the collection of blood and tissue specimens.
详细描述
This study seeks to advance patient-specific cancer immunotherapy, through the ex-vivo generation of tumor-specific T cells recognizing and targeting tumor-specific mutations.
The study will enroll 20 adult patients with a diagnosis of non-small cell lung cancer, including those with lymph node involvement. Biological samples, including tumor and healthy lung tissue, as well as peripheral blood, will be collected pre-surgery and pre-treatment. The establishment of this sample collection will enable the detailed study of tumor-specific immune responses in non-small cell lung cancer.
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
- •Participant is willing and able to provide informed consent for participation in the study.
- •Age: Adults aged 18 years or older.
- •Diagnosis: non-small cell lung cancer (Stage I-II, III), with or without lymph node involvement, ideally with sufficient tumor burden to provide adequate tissue for analysis. In accordance with good clinical practice, patients with early-stage disease will undergo direct surgery, whereas patients with advanced-stage disease will receive neoadjuvant treatment followed by surgery.
- •Ability to attend scheduled follow-up visits, if applicable, for additional peripheral blood sample collection during treatment.
排除标准
- •Presence of any active infection or underlying condition that could compromise the safety of tissue and blood sampling.
- •Prior history of another malignancy that might interfere with data interpretation related to non-small cell lung cancer progression and immune response.
- •Any current use of immunosuppressive medications (e.g., high-dose steroids) which might alter immune response assessments, except as part of non-small cell lung cancer treatment.
- •Pregnancy and breastfeeding
结局指标
主要结局
Frequency and cytotoxic activity of patient-specific tumor-reactive T cells.
时间窗: 1-30 months
The outcome will be evaluated by measuring the percentage of tumor-reactive T cells expressing activation markers (e.g., CD137, CD107a) via flow cytometry. Cytotoxic activity will be assessed through a tumor-killing assay, quantified as the percentage of tumor cell death measured by microscopy and flow cytometry.
次要结局
- Expression of activation, differentiation, and exhaustion markers in generated T cell product.(12-30 months)
研究者
Chiara Maria Cattaneo
PhD
Ospedale San Raffaele