AImmune - Artificial Intelligence Algorithm for Identification of Immunogenic Neoepitopes of Cancer to Predict and Boost Patient's Response to Immunotherapies.

Non Small Cell Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04145232
• Other study ID #: A.I.mmune
• Secondary ID: RPMP.01.02.01-12
• Status: Recruiting
• Start date: June 13, 2019
• Est. completion date: November 30, 2020

Study information

• Verified date: August 2020
• Source: Ardigen
• Contact: Martyna Balawejder
• Phone: +48 883 319 890
• Email: martyna.balawejder[@]ardigen.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: November 30, 2020
• Est. primary completion date: October 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Immunotherapy
• Neoantigens
• Neoepitopes
• Next Generation Sequencing (NGS)
• Non Small Cell Lung Cancer
• Personalized Neoantigen Cancer Vaccine

Intervention

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).

Locations

Country	Name	City	State
Poland	University Clinical Centre in Gdansk	Gdansk

Sponsors (2)

Lead Sponsor	Collaborator
Ardigen	Malopolskie Centre of Entrepreneurship

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Responders and Non-responders on immunotherapy (evaluated using RECIST 1.1 criteria)	Standard follow-up care after cancer treatment.	Up to 6 months