Clinical trial NCT04994093: Creating an Innovative AI-based Technology TCRact for Designing and Optimizing T-cell Receptors (TCR) for Use in Cancer Immunotherapies
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Cancer
Cancer
Keywords: Immunology
TCR
FFPE
PBMC
Colon Cancer
Immuno-Oncology
Cancer
Oncology
Lead sponsor: Ardigen
Sponsor class: INDUSTRY
Collaborators: name: National Center for Research and Development, Poland
First posted: 2021-08-06
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients receiving routine treatment.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Finding appropriate TCRs targeting cancer neoantigen presented on a HLA molecule (pHLA)
timeFrame: Inclusion
measure: Testing for potential TCR toxicity (targeting self antigens presented on healthy tissues)
timeFrame: Inclusion
measure: Optimization of pHLA:TCR binding affinity and toxicity
timeFrame: Inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Kraków
country: Poland
facility: Maria Sklodowska-Curie National Research Institute of Oncology
Study officials:
References: