Creating an Innovative AI-based Technology TCRact for Designing and Optimizing T-cell Receptors (TCR) for Use in Cancer Immunotherapies

Sponsor

Ardigen (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04994093

Collaborator

National Center for Research and Development, Poland (Other)

100

Enrollment

Location

13.8

Anticipated Duration (Months)

7.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The PROJECT OBJECTIVE is to create an innovative AI-based (Artificial Intelligence) IN SILICO TECHNOLOGY for the design and optimization of T-cell receptors (TCRs) capable of recognizing specific tumor antigens presented on Human Leukocyte Antigen (HLA). The technology will be based on bioinformatics (including molecular modelling) and artificial intelligence (including predictive, generative and optimization models). PROJECT TASKS are dedicated to the implementation of individual technological components (including the database necessary for their preparation) and to performing IN VITRO evaluation rounds to optimize the technology.

Integration, within an IN SILICO TECHNOLOGY, of processes which currently require huge amounts of in vitro laboratory experiments that are necessary for bringing new TCR-based cancer immunotherapies into clinical trials:

finding appropriate TCRs targeting cancer neoantigen presented on a HLA molecule (pHLA)
testing for potential TCR toxicity (targeting self antigens presented on healthy tissues)
optimization of pHLA:TCR binding affinity and toxicity.

Condition or Disease	Intervention/Treatment	Phase
Colon Cancer Cancer	Other: Collection of blood (PBMC), biopsy (FFPE) and stool samples.

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

Creating an Innovative AI-based (Artificial Intelligence) IN SILICO TECHNOLOGY TCRact to Launch a NEW SERVICE for Designing and Optimizing T-cell Receptors (TCR) for Use in Cancer Immunotherapies

Actual Study Start Date :

Oct 6, 2021

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
COLON CANCER This cohort will consist of 100 patients with Colon Cancer.	Other: Collection of blood (PBMC), biopsy (FFPE) and stool samples. Patients receiving routine treatment financed by the Polish National Health Fund (NFZ).

Arm

Intervention/Treatment

COLON CANCER

This cohort will consist of 100 patients with Colon Cancer.

Other: Collection of blood (PBMC), biopsy (FFPE) and stool samples.

Patients receiving routine treatment financed by the Polish National Health Fund (NFZ).

Outcome Measures

Primary Outcome Measures

Finding appropriate TCRs targeting cancer neoantigen presented on a HLA molecule (pHLA) [Inclusion]
Testing for potential TCR toxicity (targeting self antigens presented on healthy tissues) [Inclusion]
Optimization of pHLA:TCR binding affinity and toxicity [Inclusion]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Clinical diagnosis of advanced resectable colorectal cancer (Active stage III or IV)
Histopathologically confirmed as adenocarcinoma
Age 18 or over
Being able to understand and sign the Informed Consent Form (ICF)
Qualification for resection within 3 months from W0 or condition after primary tumor resection, not longer than 5 years from surgery

Exclusion Criteria:

Mucinous colorectal adenocarcinoma
Canal and anal edge cancer,
Adenocarcinoma of the appendix,
Patients treated with neoadjuvant therapy or radiation therapy in the 3 months prior to study enrollment.
Patients treated with systemic chemotherapy in the 3 months prior to study enrollment.
Histopathological diagnosis other than adenocarcinoma
Remission
History of inflammatory bowel diseases
Pregnancy
HIV infection
Active infection with hepatitis B and C viruses
Leukocytopenia