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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04145232
Enrollment
30
Registered
2019-10-30
Start date
2019-06-13
Completion date
2020-11-30
Last updated
2020-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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)

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.

Interventions

BIOLOGICALCollection 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).

Sponsors

Małopolskie Centre of Entrepreneurship
CollaboratorUNKNOWN
Ardigen
Lead SponsorINDUSTRY

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of Responders and Non-responders on immunotherapy (evaluated using RECIST 1.1 criteria)Up to 6 monthsStandard follow-up care after cancer treatment.

Countries

Poland

Contacts

Primary ContactMartyna Balawejder
martyna.balawejder@ardigen.com+48 883 319 890
Backup ContactBozena Augustyn
bozena.augustyn@ardigen.com+48 12 340 94 94

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026