Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2025-12-28 @ 8:29 PM
Study NCT ID:
NCT04745403
Status:
RECRUITING
Last Update Posted:
2023-11-18
First Post:
2021-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Redirected HBV-Specific T Cells in Patients With HBV-related HCC (SAFE-T-HBV)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D006509', 'term': 'Hepatitis B'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2028-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-15', 'studyFirstSubmitDate': '2021-01-25', 'studyFirstSubmitQcDate': '2021-02-08', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety evaluation of mRNA HBV/TCR T-cell treatment', 'timeFrame': 'Start of treatment until 28 days post last dose', 'description': 'Based on incidence and severity of adverse events'}, {'measure': 'Analysis of modifications of tumour microenvironment caused by mRNA HBV/TCR T-cell treatment', 'timeFrame': 'Start of treatment until end of study', 'description': 'Histological staining using biopsy and analysis of serum factors such as cytokines and chemokines'}], 'secondaryOutcomes': [{'measure': 'Evaluation of anti-tumor efficacy of mRNA HBV/TCR T-cell treatment', 'timeFrame': 'Up to 4 years', 'description': 'Objective response rate (ORR)'}, {'measure': 'Evaluation of anti-tumor efficacy of mRNA HBV/TCR T-cell treatment', 'timeFrame': 'Up to 4 years', 'description': 'Progression free survival (PFS)'}, {'measure': 'Evaluation of anti-tumor efficacy of mRNA HBV/TCR T-cell treatment', 'timeFrame': 'Up to 4 years', 'description': 'Overall survival (OS)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hepatitis B virus', 'Hepatocellular Carcinoma'], 'conditions': ['Hepatocellular Carcinoma']}, 'referencesModule': {'references': [{'pmid': '23941866', 'type': 'RESULT', 'citation': 'Koh S, Shimasaki N, Suwanarusk R, Ho ZZ, Chia A, Banu N, Howland SW, Ong AS, Gehring AJ, Stauss H, Renia L, Sallberg M, Campana D, Bertoletti A. A practical approach to immunotherapy of hepatocellular carcinoma using T cells redirected against hepatitis B virus. Mol Ther Nucleic Acids. 2013 Aug 13;2(8):e114. doi: 10.1038/mtna.2013.43.'}, {'pmid': '28737510', 'type': 'RESULT', 'citation': 'Kah J, Koh S, Volz T, Ceccarello E, Allweiss L, Lutgehetmann M, Bertoletti A, Dandri M. Lymphocytes transiently expressing virus-specific T cell receptors reduce hepatitis B virus infection. J Clin Invest. 2017 Aug 1;127(8):3177-3188. doi: 10.1172/JCI93024. Epub 2017 Jul 24.'}, {'pmid': '30711630', 'type': 'RESULT', 'citation': 'Tan AT, Yang N, Lee Krishnamoorthy T, Oei V, Chua A, Zhao X, Tan HS, Chia A, Le Bert N, Low D, Tan HK, Kumar R, Irani FG, Ho ZZ, Zhang Q, Guccione E, Wai LE, Koh S, Hwang W, Chow WC, Bertoletti A. Use of Expression Profiles of HBV-DNA Integrated Into Genomes of Hepatocellular Carcinoma Cells to Select T Cells for Immunotherapy. Gastroenterology. 2019 May;156(6):1862-1876.e9. doi: 10.1053/j.gastro.2019.01.251. Epub 2019 Jan 31.'}]}, 'descriptionModule': {'briefSummary': 'This is a single center, single arm and open-label study to determine the safety of mRNA modified HBV-TCR redirected T-cells and to analyze the changes in tumor microenvironment caused by these HBV-TCR redirected T-cells in subjects with HBV-related HCC who are not amenable to/failed conventional treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n1. Eastern Cooperative Oncology Group (ECOG) performance status ≤1\n2. Presence of primary hepatocellular carcinoma in the liver with presence of measurable tumour by RECIST 1.1 criteria, that is not amenable to, or failed, conventional treatment options\n3. Serum HBsAg positivity\n4. Non-cirrhotic or compensated cirrhosis Child-Pugh A (5 - 6 points)\n5. Life expectancy of at least 3 months\n6. HLA class 1 profile matching HLA-class I restriction element of the available T cell receptors (restricted by either HLA-A\\*02:01 or HLA-A\\*24:02).\n\nKey Exclusion Criteria:\n\n1. Brain metastasis\n2. Second primary malignancy that is clinically detectable at the time of consideration for study enrolment, except for in situ carcinoma of the cervix, non-melanoma skin carcinoma localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer and superficial bladder tumors\n3. Use of immune checkpoint inhibitors and/or tyrosine kinase inhibitor (TKI) within 5 half-lives of the drug prior to baseline liver biopsy procedure\n4. Alterations of concomitant medications which could potentially cause drug induced liver injury and affect liver biopsy result within 3 months of baseline liver biopsy procedure.\n5. Likelihood to require any immunosuppressive treatments during the period of the clinical trial.\n6. 7\\. Last RFA/TACE treatment within 3 months prior to first LioCyx-M infusion; Last Y90 therapy treatment within 6 months prior to first dose of mRNA HBV/TCR T-cells\n7. Decompensated cirrhosis Child-Pugh B or C (7 - 15 points)\n8. Concurrent administration of any other anti-tumour therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.\n9. Use of any investigational product (IP) or investigational medical device within 30 days of study drug administration\n10. Serum HBV DNA levels ≥ 200 IU/ml at screening\n11. Serum HBsAg levels ≥ 10,000 IU/ml at screening\n12. Lack of peripheral venous or central venous access or any condition that would interfere with drug administration or collection of study samples\n13. Any condition or active infections which, in the investigator's opinion, makes the subject unsuitable for trial participation\n14. Women who are pregnant or breast-feeding"}, 'identificationModule': {'nctId': 'NCT04745403', 'acronym': 'SAFE-T-HBV', 'briefTitle': 'Redirected HBV-Specific T Cells in Patients With HBV-related HCC (SAFE-T-HBV)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lion TCR Pte. Ltd.'}, 'officialTitle': 'Safety and Tolerability Study of Redirected HBV-Specific T Cells in Patients With Hepatitis B Virus (HBV)-Related Hepatocellular Carcinoma (SAFE-T-HBV)', 'orgStudyIdInfo': {'id': 'LTCR-HCC-3-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mRNA HBV/TCR T-cells', 'description': 'Escalating regime from 1x10e5 to 5-10x10e6 cells/kg bodyweight (BW) every 2 weeks.', 'interventionNames': ['Drug: mRNA HBV/TCR T-cells']}], 'interventions': [{'name': 'mRNA HBV/TCR T-cells', 'type': 'DRUG', 'description': 'Study Infusion\n\nThe first dose of mRNA HBV-TCR T-cells at dose 1x10e5/kg BW will be infused on Day 0, and subsequently incremental doses on Day 14 and 28, up to the dose of 5-10x10e6/kg BW.', 'armGroupLabels': ['mRNA HBV/TCR T-cells']}]}, 'contactsLocationsModule': {'locations': [{'zip': '169608', 'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Thinesh L Krishnamoorthy', 'role': 'CONTACT', 'email': 'thinesh.l.krishnamoorthy@singhealth.com.sg', 'phone': '62223322'}, {'role': 'CONTACT', 'email': 'thinesh.l.krishnamoorthy@singhealth.com.sg', 'phoneExt': 'Krishnamoorthy'}, {'name': 'Thinesh L Krishnamoorthy', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Singapore General Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'centralContacts': [{'name': 'Royce Fam', 'role': 'CONTACT', 'email': 'royce.fam@liontcr.com', 'phone': '69260818'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lion TCR Pte. Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}