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

June 25, 2024 updated by: Ardigen

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

118

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Kraków, Poland
        • Maria Sklodowska-Curie National Research Institute of Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients receiving routine treatment.

Description

Inclusion Criteria:

  • Clinical diagnosis of advanced resectable colorectal cancer (Active stage II, 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
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).

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ardigen

Collaborators

National Center for Research and Development, Poland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 6, 2021

Primary Completion (Actual)

December 5, 2022

Study Completion (Actual)

December 28, 2023

Study Registration Dates

First Submitted

July 29, 2021

First Submitted That Met QC Criteria

August 5, 2021

First Posted (Actual)

August 6, 2021

Study Record Updates

Last Update Posted (Actual)

June 26, 2024

Last Update Submitted That Met QC Criteria

June 25, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCRact
  • POIR.01.01.01-00-0019/20 (Other Grant/Funding Number: The National Centre for Research and Development)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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