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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
Sponsor:
Collaborator:
Małopolskie Centre of Entrepreneurship
Information provided by (Responsible Party):
Ardigen

Brief Summary:

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

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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

Group/Cohort Intervention/treatment
NSCLC
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).
Other Names:
  • Nivolumab
  • Ipilimumab
  • Atezolizumab




Primary Outcome Measures :
  1. 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
biopsy (FFPE), peripheral blood samples (PBMC) and stool


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients receiving routine treatment.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

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


Contacts
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Contact: Emilia Strycharz-Angrecka +48 12 340 94 94 emilia.strycharz-angrecka@ardigen.com
Contact: Bozena Augustyn +48 12 340 94 94 bozena.augustyn@ardigen.com

Locations
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Poland
University Clinical Centre in Gdansk Recruiting
Gdańsk, Poland
Sponsors and Collaborators
Ardigen
Małopolskie Centre of Entrepreneurship
Investigators
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Principal Investigator: Piotr Stepniak Ardigen

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Responsible Party: Ardigen
ClinicalTrials.gov Identifier: NCT04145232     History of Changes
Other Study ID Numbers: A.I.mmune
RPMP.01.02.01-12-0301/17 ( Other Grant/Funding Number: Małopolskie Centre of Entrepreneurship )
First Posted: October 30, 2019    Key Record Dates
Last Update Posted: October 30, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ardigen:
Cancer
Non Small Cell Lung Cancer
Neoepitopes
Neoantigens
Immunotherapy
Nivolumab
Ipilimumab
Atezolizumab
Neoantigen cancer vaccine
Personalized neoantigen cancer vaccine
FFPE
PBMC
Stool
Immuno-Oncology
Next generation sequencing (NGS)
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Nivolumab
Ipilimumab
Atezolizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents