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CompletedNCT04994093Updated Jun 26, 2024

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

An observational study in Colon Cancer and Cancer, sponsored by Ardigen. Completed at 1 site in Poland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-26.

Sponsored by Ardigen · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
118
Ages
18 Years and older
Sex
All
01

Study 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.
02

Conditions studied

  • Colon Cancer
  • Cancer

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Keywords

  • Immunology
  • TCR
  • FFPE
  • PBMC
  • Colon Cancer
  • Immuno-Oncology
  • Cancer
  • Oncology
03

In context

Colonic Neoplasms

1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.

This study's enrollment of 118 is below the median of 280 across 349 observational studies indexed under Colonic Neoplasms.

Browse Colonic Neoplasms studies →

Lead sponsor

Ardigen is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients receiving routine treatment.

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

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
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
118 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • COLON CANCER

    This cohort will consist of 100 patients with Colon Cancer.

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

Interventions

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

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

06

What researchers measure

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

07

Study locations

1 site
  • Maria Sklodowska-Curie National Research Institute of Oncology
    Kraków, Poland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04994093
Lead sponsor
Ardigen
Collaborators
National Center for Research and Development, Poland
Responsible party
Sponsor
First posted
Aug 6, 2021
Start date
Oct 6, 2021
Primary completion
Dec 5, 2022
Completion
Dec 28, 2023
Last update
Jun 26, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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