AImmune - Artificial Intelligence Algorithm for Identific... | NCT04145232

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

NCT04145232

Sponsor

Ardigen

Status

Unknown status

Last Update Posted

Aug 10, 2020Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

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

Interventions

Collection of biopsy (FFPE), blood (PBMC) and stool

Countries

Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
RPMP.01.02.01-12-0301/17	Other Grant/Funding Number	Małopolskie Centre of Entrepreneurship

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 13, 2019Actual

Primary Completion Date

Oct 15, 2020Estimated

Completion Date

Nov 30, 2020Estimated

First Submitted Date

Oct 29, 2019

First Submission Date that Met QC Criteria

Oct 29, 2019

First Posted Date

Oct 30, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 7, 2020

Last Update Posted Date

Aug 10, 2020Actual

Name	Class
Małopolskie Centre of Entrepreneurship	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Conditions Module

Conditions

Non Small Cell Lung Cancer
Neoepitopes
Neoantigens
Immunotherapy
Next Generation Sequencing (NGS)
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)

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NSCLC		This cohort will consist of 30 patients with non-small cell lung cancer (NSCLC).	Biological: Collection of biopsy (FFPE), blood (PBMC) and stool

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Collection of biopsy (FFPE), blood (PBMC) and stool	Biological	Patients receiving routine treatment (immunotherapy using anti-PD1 / anti-PDL1 and / or anti CTLA4 antibodies), financed by the Polish National Health Fund (NFZ).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients receiving routine treatment.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Martyna Balawejder	Contact	+48 883 319 890		martyna.balawejder@ardigen.com
Bozena Augustyn	Contact	+48 12 340 94 94		bozena.augustyn@ardigen.com

Overall Officials

Name	Affiliation	Role
Piotr Stepniak	Ardigen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Clinical Centre in Gdansk	Recruiting	Gdansk			Poland

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

MeSH Terms

ID	Term
D002289	Carcinoma, Non-Small-Cell Lung
D009369	Neoplasms

Ancestor Terms

ID	Term
D002283	Carcinoma, Bronchogenic
D001984	Bronchial Neoplasms
D008175	Lung Neoplasms
D012142	Respiratory Tract Neoplasms
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

ID	Term
D001800	Blood Specimen Collection
D000077594	Nivolumab
D000074324	Ipilimumab
C000594389	atezolizumab

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D011677	Punctures
D013514	Surgical Procedures, Operative
D008919	Investigative Techniques
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins