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NCT04994093Completed

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

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

Source: ClinicalTrials.gov · Last updated 26 Jun 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
118 (actual)
First submitted
29 Jul 2021
Start date
6 Oct 2021
Primary completion date
5 Dec 2022
Lead sponsor
Ardigen
NCT number
NCT04994093

What you commit to

  • Study type: Observational
  • Participants enrolled: 118
  • From 6 Oct 2021 to the primary completion date, 5 Dec 2022
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other illness

  • Canal and anal edge cancer,
  • History of inflammatory bowel diseases
  • HIV infection
  • Active infection with hepatitis B and C viruses

Other

  • Mucinous colorectal adenocarcinoma
  • Adenocarcinoma of the appendix,
  • Histopathological diagnosis other than adenocarcinoma
  • Remission
  • Pregnancy
  • Leukocytopenia

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Maria Sklodowska-Curie National Research Institute of Oncology
Coordinator of this site? Confirm its status
KrakowPolandUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.