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

NCT04994093 | Completed

• 2 other identifiers: TCRactPOIR.01.01.01-00-0019/20
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Cancer; Cancer

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

COLON CANCER

This cohort will consist of 100 patients with Colon Cancer.

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

Interventions

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

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

COLON CANCER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients receiving routine treatment.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ardigen: lead
• National Center for Research and Development, Poland: collaborator

Study Sites (1)

Maria Sklodowska-Curie National Research Institute of Oncology

Krakow, Poland

Location

Related Publications (1)

• Bujak J, Klek S, Balawejder M, Kociniak A, Wilkus K, Szatanek R, Orzeszko Z, Welanyk J, Torbicz G, Jeckowski M, Kucharczyk T, Wohadlo L, Borys M, Stadnik H, Wysocki M, Kayser M, Slomka ME, Kosmowska A, Horbacka K, Gach T, Markowska B, Kowalczyk T, Karon J, Karczewski M, Szura M, Sanecka-Duin A, Blum A. Creating an Innovative Artificial Intelligence-Based Technology (TCRact) for Designing and Optimizing T Cell Receptors for Use in Cancer Immunotherapies: Protocol for an Observational Trial. JMIR Res Protoc. 2023 Jul 13;12:e45872. doi: 10.2196/45872.

  PMID: 37440307 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

stool, biopsy (FFPE) and peripheral blood samples (PBMC)

MeSH Terms

Conditions

Colonic Neoplasms; Neoplasms

Interventions

Biopsy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: August 6, 2021
• Study Start: October 6, 2021
• Primary Completion: December 5, 2022
• Study Completion: December 28, 2023
• Last Updated: June 26, 2024

Record last verified: 2024-06

Locations

PL (1)