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OpenTrials
Completed

NCT Number: NCT04994093

Creating an Innovative AI-based Technology TCRact 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.

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Key information

Conditions

Colon Cancer Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Maria Sklodowska-Curie National Research Institute of Oncology

Krakow, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

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

Primary outcomes

  1. Finding appropriate TCRs targeting cancer neoantigen presented on a HLA molecule (pHLA)

    Time frame: Inclusion

  2. Testing for potential TCR toxicity (targeting self antigens presented on healthy tissues)

    Time frame: Inclusion

  3. Optimization of pHLA:TCR binding affinity and toxicity

    Time frame: Inclusion

Sponsors and collaborators

Lead sponsor

Ardigen

Industry

Collaborators

  • National Center for Research and Development, Poland

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Aug 6, 2021
Registry last updated
Jun 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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