Creating an Innovative AI-based (Artificial Intelligence) IN SILICO TECHNOLOGY TCRact to Launch a NEW SERVICE for Designing and Optimizing T-cell Receptors (TCR) for Use in Cancer Immunotherapies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Ardigen
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Optimization of pHLA:TCR binding affinity and toxicity
研究概览
简要总结
The PROJECT OBJECTIVE is to create an innovative AI-based (Artificial Intelligence) IN SILICO TECHNOLOGY for the design and optimization of T-cell receptors (TCRs) capable of recognizing specific tumor antigens presented on Human Leukocyte Antigen (HLA). The technology will be based on bioinformatics (including molecular modelling) and artificial intelligence (including predictive, generative and optimization models). PROJECT TASKS are dedicated to the implementation of individual technological components (including the database necessary for their preparation) and to performing IN VITRO evaluation rounds to optimize the technology.
Integration, within an IN SILICO TECHNOLOGY, of processes which currently require huge amounts of in vitro laboratory experiments that are necessary for bringing new TCR-based cancer immunotherapies into clinical trials:
- finding appropriate TCRs targeting cancer neoantigen presented on a HLA molecule (pHLA)
- testing for potential TCR toxicity (targeting self antigens presented on healthy tissues)
- optimization of pHLA:TCR binding affinity and toxicity.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
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
- •Clinical diagnosis of advanced resectable colorectal cancer (Active stage II, III or IV)
- •Histopathologically confirmed as adenocarcinoma
- •Age 18 or over
- •Being able to understand and sign the Informed Consent Form (ICF)
- •Qualification for resection within 3 months from W0 or condition after primary tumor resection, not longer than 5 years from surgery
排除标准
- •Mucinous colorectal adenocarcinoma
- •Canal and anal edge cancer,
- •Adenocarcinoma of the appendix,
- •Patients treated with neoadjuvant therapy or radiation therapy in the 3 months prior to study enrollment.
- •Patients treated with systemic chemotherapy in the 3 months prior to study enrollment.
- •Histopathological diagnosis other than adenocarcinoma
- •Remission
- •History of inflammatory bowel diseases
- •Pregnancy
- •HIV infection
- •Active infection with hepatitis B and C viruses
- •Leukocytopenia
结局指标
主要结局
Optimization of pHLA:TCR binding affinity and toxicity
时间窗: Inclusion
Finding appropriate TCRs targeting cancer neoantigen presented on a HLA molecule (pHLA)
时间窗: Inclusion
Testing for potential TCR toxicity (targeting self antigens presented on healthy tissues)
时间窗: Inclusion
次要结局
未报告次要终点