Ignite Creation Date:
2025-12-25 @ 1:01 AM
Ignite Modification Date:
2025-12-27 @ 12:34 PM
Study NCT ID:
NCT04994093
Status:
COMPLETED
Last Update Posted:
2024-06-26
First Post:
2021-07-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Creating an Innovative AI-based Technology TCRact for Designing and Optimizing T-cell Receptors (TCR) for Use in Cancer Immunotherapies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001706', 'term': 'Biopsy'}], 'ancestors': [{'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'stool, biopsy (FFPE) and peripheral blood samples (PBMC)'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 118}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-12-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-25', 'studyFirstSubmitDate': '2021-07-29', 'studyFirstSubmitQcDate': '2021-08-05', 'lastUpdatePostDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immunology', 'TCR', 'FFPE', 'PBMC', 'Colon Cancer', 'Immuno-Oncology', 'Cancer', 'Oncology'], 'conditions': ['Colon Cancer', 'Cancer']}, 'referencesModule': {'references': [{'pmid': '37440307', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nIntegration, 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:\n\n* finding appropriate TCRs targeting cancer neoantigen presented on a HLA molecule (pHLA)\n* testing for potential TCR toxicity (targeting self antigens presented on healthy tissues)\n* optimization of pHLA:TCR binding affinity and toxicity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients receiving routine treatment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of advanced resectable colorectal cancer (Active stage II, III or IV)\n* Histopathologically confirmed as adenocarcinoma\n* Age 18 or over\n* Being able to understand and sign the Informed Consent Form (ICF)\n* Qualification for resection within 3 months from W0 or condition after primary tumor resection, not longer than 5 years from surgery\n\nExclusion Criteria:\n\n* Mucinous colorectal adenocarcinoma\n* Canal and anal edge cancer,\n* Adenocarcinoma of the appendix,\n* Patients treated with neoadjuvant therapy or radiation therapy in the 3 months prior to study enrollment.\n* Patients treated with systemic chemotherapy in the 3 months prior to study enrollment.\n* Histopathological diagnosis other than adenocarcinoma\n* Remission\n* History of inflammatory bowel diseases\n* Pregnancy\n* HIV infection\n* Active infection with hepatitis B and C viruses\n* Leukocytopenia'}, 'identificationModule': {'nctId': 'NCT04994093', 'briefTitle': 'Creating an Innovative AI-based Technology TCRact for Designing and Optimizing T-cell Receptors (TCR) for Use in Cancer Immunotherapies', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ardigen'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'TCRact'}, 'secondaryIdInfos': [{'id': 'POIR.01.01.01-00-0019/20', 'type': 'OTHER_GRANT', 'domain': 'The National Centre for Research and Development'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'COLON CANCER', 'description': 'This cohort will consist of 100 patients with Colon Cancer.', 'interventionNames': ['Other: Collection of blood (PBMC), biopsy (FFPE) and stool samples.']}], 'interventions': [{'name': 'Collection of blood (PBMC), biopsy (FFPE) and stool samples.', 'type': 'OTHER', 'description': 'Patients receiving routine treatment financed by the Polish National Health Fund (NFZ).', 'armGroupLabels': ['COLON CANCER']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Krakow', 'country': 'Poland', 'facility': 'Maria Sklodowska-Curie National Research Institute of Oncology', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ardigen', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Center for Research and Development, Poland', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}