AImmune - Artificial Intelligence Algorithm for Identification of Immunogenic Neoepitopes of Cancer to Predict and Boost Patient's Response to Immunotherapies.
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|ClinicalTrials.gov Identifier: NCT04145232|
Recruitment Status : Recruiting
First Posted : October 30, 2019
Last Update Posted : October 30, 2019
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.
|Condition or disease||Intervention/treatment|
|Non Small Cell Lung Cancer Neoepitopes Neoantigens Immunotherapy Next Generation Sequencing (NGS) Personalized Neoantigen Cancer Vaccine||Biological: Collection of biopsy (FFPE), blood (PBMC) and stool|
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||Development of AImmune Technology as a Bioinformatic Component of Diagnostic Tests Used in Cancer Immunotherapy|
|Actual Study Start Date :||June 13, 2019|
|Estimated Primary Completion Date :||June 30, 2020|
|Estimated Study Completion Date :||November 30, 2020|
This cohort will consist of 30 patients with non-small cell lung cancer (NSCLC).
Biological: Collection of biopsy (FFPE), blood (PBMC) and stool
Patients receiving routine treatment (immunotherapy using anti-PD1 / anti-PDL1 and / or anti CTLA4 antibodies), financed by the Polish National Health Fund (NFZ).
- Number of Responders and Non-responders on immunotherapy (evaluated using RECIST 1.1 criteria) [ Time Frame: Up to 6 months ]Standard follow-up care after cancer treatment.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04145232
|Contact: Emilia Strycharz-Angrecka||+48 12 340 94 firstname.lastname@example.org|
|Contact: Bozena Augustyn||+48 12 340 94 email@example.com|
|University Clinical Centre in Gdansk||Recruiting|
|Principal Investigator:||Piotr Stepniak||Ardigen|