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临床试验/NCT04145232
NCT04145232Unknown不适用

Development of AImmune Technology as a Bioinformatic Component of Diagnostic Tests Used in Cancer Immunotherapy

Ardigen1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年6月13日最近更新:
适应症

试验速览

阶段
不适用
发起方
Ardigen
入组人数
30
试验地点
1
主要终点
Number of Responders and Non-responders on immunotherapy (evaluated using RECIST 1.1 criteria)

研究概览

简要总结

The goal of the project is to develop and validate A.I.mmune technology. It performs complex analyses of patients' tumor and immune system state using data derived from next-generation sequencing of tumor and healthy tissue to identify cancer neoantigens, which are likely to elicit an immune response.

A key challenge to be solved using the technology is to predict for each patient which neoepitopes are not only likely to bind to HLA or be presented on the tumor cell surface, but also will be recognized by the T-cell receptor and create the immunogenic response. The presence of such epitopes is required for immunotherapy by immune checkpoint inhibition to have an effect on the disease. Knowledge of those epitopes enables therapeutic strategies to boost the immune response by designing personalized cancer vaccines and adoptive cell therapies.

The samples and data collected in this clinical study will be used for clinical validation of A.I.mmune technology. For all patients treated with immunotherapy (using anti-PD1 / anti-PDL1 and / or anti-CTLA-4 antibodies) peripheral blood samples (PBMC) and biopsy (FFPE) collection will be performed before treatment. Samples will be sequenced by next-generation sequencing platform. In parallel, the investigators will also collect samples of stool (one sample before the start of immunotherapy) and follow-up information of responses to treatment.

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

入选标准

  • Men or women ≥18 years of age.
  • Patients with non-small cell lung cancer.
  • Patients with informed consent to participate in the study.
  • Patients receiving routine treatment (immunotherapy using anti-PD1 / anti-PDL1 and / or anti CTLA4 antibodies), financed by the Polish National Health Fund (NFZ).
  • The applied immunotherapy should be the first or second line of treatment.

排除标准

  • Patients who are unable to understand, read and / or sign informed consent.
  • Patients who can not collect stools.
  • Patients with fecal transplant.
  • The applied immunotherapy is not the first or second line of treatment.

结局指标

主要结局

Number of Responders and Non-responders on immunotherapy (evaluated using RECIST 1.1 criteria)

时间窗: Up to 6 months

Standard follow-up care after cancer treatment.

次要结局

未报告次要终点

研究者

发起方
Ardigen
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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