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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04994093

Enrollment

118

Registered

2021-08-06

Start date

2021-10-06

Completion date

2023-12-28

Last updated

2024-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Colon Cancer

Keywords

Immunology, TCR, FFPE, PBMC, Colon Cancer, Immuno-Oncology, Cancer, Oncology

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.

Interventions

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

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

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026