Trials / Unknown
UnknownNCT04145232
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
- Phase
- —
- Study type
- Observational
- Enrollment
- 30 (estimated)
- Sponsor
- Ardigen · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Non Small Cell Lung Cancer
- Neoepitopes
- Neoantigens
- Immunotherapy
- Next Generation Sequencing (NGS)
- Personalized Neoantigen Cancer Vaccine
Interventions
| Type | Name | Description |
|---|---|---|
| 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). |
Timeline
- Start date
- 2019-06-13
- Primary completion
- 2020-10-15
- Completion
- 2020-11-30
- First posted
- 2019-10-30
- Last updated
- 2020-08-10
Locations
1 site across 1 country: Poland
Source: ClinicalTrials.gov record NCT04145232. Inclusion in this directory is not an endorsement.