Prospective Collection of Donor Tissue and Whole Blood or Leukapheresis Product From Patients With Solid Tumours to Enable Development of Methods for the Manufacturing of Clonal Neoantigen T Cell Products (cNeT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 221
- 试验地点
- 1
- 主要终点
- Obtaining samples for research
研究概览
简要总结
This is a multi-solid tumour research study which collects tumour samples from patients alongside a matched whole blood, and/or leukapheresis product for the development of manufacturing processes for potential immunotherapies.
详细描述
During standard of care surgery tumour samples which are surplus to the requirements of the patients diagnostic/treatment pathway will be procured along with a matched whole blood and/or leukapheresis sample. In some instances patients may consent to provide a non-standard of care, non-invasive research biopsy.
Within 28-42 days following procurement of samples patients will be required to participate in a safety follow up call for assessment of any procedure related adverse events.
研究设计
- 研究类型
- Observational
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
- •Aged ≥ 18 years
- •Written informed patient consent for tissue, blood collection or leukapheresis, including storage and manipulation.
- •Suspected or confirmed diagnosis of selective solid tumours with either primary, recurrent or metastatic disease.
- •Patient is scheduled for surgical excision and/or collection of multiple tissue samples via image or device guided biopsy, has a superficial skin or subcutaneous lymph node metastasis that can be safely accessed for the purposes of the study.
- •Haemoglobin(Hb) ≥ 10g/dL without transfusion support for at least 3 weeks (for patients donating whole blood).
- •White cell count ≥ 3 x 10^9/L (for patients donating whole blood).
- •For selected solid tumours and leukapheresis procedure additional inclusion criteria apply.
排除标准
- •Clinical status precludes surgical removal of, or collection of multiple biopsies from, accessible tumour tissue.
- •Inadequate peripheral venous access precluding collection of blood.
- •Pregnant or breastfeeding women.
- •Known/laboratory confirmed diagnosis of an active infectious disease to include Hepatitis B and C, human immunodeficiency virus infection (HIV1/2), Human t-lymphotropic virus (HTLV I/II) and syphilis.
- •Patients who are currently participating in a clinical trial involving an unlicensed medical product.
- •Patients who have received any cytotoxic therapy (including investigational products) within three weeks prior to tissue procurement.
- •Patients receiving immunosuppressive treatments or who require regular treatment with steroids at a dose higher than prednisolone 10 mg/day (or equivalent).
- •Any medical reason why, in the opinion of the investigator, the patient should not participate in this study.
- •For selected solid tumours and leukapheresis procedure additional exclusion criteria apply.
结局指标
主要结局
Obtaining samples for research
时间窗: 5 years
This protocol does not have an analysis primary outcome measure. It will be conducted in accordance with the principles of Good Clinical Practice (GCP), solely for the purpose of obtaining samples for research.
次要结局
未报告次要终点