NCT06914635招募中不适用
Immunotherapy: Care and Prevention of Infectious and Tumoral Diseases (ImmunoHUB)
Fondazione IRCCS Policlinico San Matteo di Pavia1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年5月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The efficiency of antibodies will be evaluated toward SARS-CoV-2 and liver primary tumor cells by functional in vitro tests.
研究概览
简要总结
The project comprises two research lines. In the line 1, human monoclonal antibodies toward SARS-CoV-2 will be generate and characterized by in vitro functional tests. In the line 2, in vitro tests will be performed to evaluate the efficency of immune response mediated by antibodies direct to specific tumor molecules.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Line 1: - Age >18 at time of signing informed consent form
- •Signed informed consent form Line 2: - Primery liver tumor
- •Age >18 at time of signing informed consent form
- •Signed informed consent form
排除标准
- •Line 1: - Active or history of neoplastic malignancy
- •Active autoimmune disease ongoing treatment with immunosuppressive therapy
- •Evidence of positive HIV, HCV, HBV test
- •Failure to sign informed consent form Line 2: - Concomitant diseases with life expectancy of less than 12 months
- •Chronic autoimmune or inflammatory diseases
- •Treatment with atezolizumab, bevacizumab, sorafenib, lenvatinib, regorafenib, cabozantinib, checkpoint inhibitors and tyrosine kinase inhibitors or anti-VEGF therapies
- •Other extrahepatic neoplasms occurring or in the last 3 years except for tumors resected with curative intent and without evidence of relapse for >3 years prior to signing informed consent and considered low risk of relapse
- •HIV infection
- •Failure to sign informed consent form
结局指标
主要结局
The efficiency of antibodies will be evaluated toward SARS-CoV-2 and liver primary tumor cells by functional in vitro tests.
时间窗: From enrollement to 24 weeks
次要结局
未报告次要终点
研究者
Mario Mondelli
MD
Fondazione IRCCS Policlinico San Matteo di Pavia
研究点 (1)
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