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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04994093
• Other study ID #: TCRact
• Secondary ID: POIR.01.01.01-00
• Status: Recruiting
• Start date: October 6, 2021
• Est. completion date: December 2022

Study information

• Verified date: December 2021
• Source: Ardigen
• Contact: Martyna Balawejder
• Phone: +48 883 319 890
• Email: martyna.balawejder[@]ardigen.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of advanced resectable colorectal cancer (Active stage 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

Related Conditions & MeSH terms

• Cancer
• Colon Cancer
• Colonic Neoplasms

Intervention

Other:
• Collection of blood (PBMC), biopsy (FFPE) and stool samples.
Patients receiving routine treatment financed by the Polish National Health Fund (NFZ).

Locations

Country	Name	City	State
Poland	Maria Sklodowska-Curie National Research Institute of Oncology	Kraków

Sponsors (2)

Lead Sponsor	Collaborator
Ardigen	National Center for Research and Development, Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Finding appropriate TCRs targeting cancer neoantigen presented on a HLA molecule (pHLA)		Inclusion
Primary	Testing for potential TCR toxicity (targeting self antigens presented on healthy tissues)		Inclusion
Primary	Optimization of pHLA:TCR binding affinity and toxicity		Inclusion