Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-31 @ 3:20 PM
Study NCT ID:
NCT03998033
Status:
TERMINATED
Last Update Posted:
2022-08-23
First Post:
2019-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of ET140202 T Cells in Adults With Advanced Hepatocellular Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}], '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': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Reallocation of resources to new HCC study.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-19', 'studyFirstSubmitDate': '2019-06-07', 'studyFirstSubmitQcDate': '2019-06-24', 'lastUpdatePostDateStruct': {'date': '2022-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence rates of adverse events (AEs) after infusion of ET140202 T cells', 'timeFrame': '28 days', 'description': 'Safety and tolerability of ET140202 T cells as assessed by committee review of dose limiting toxicities (DLTs) and incidence and severity of adverse events (AEs) after infusion'}, {'measure': 'The recommended phase 2 dose (RP2D) regimen of ET140202 T-cell therapy', 'timeFrame': 'up to 2 years', 'description': 'The RP2D will be determined by the study Dose Escalation Committee (DEC) and primarily based on DLT, and secondarily on the best tumor response'}], 'secondaryOutcomes': [{'measure': 'Assess efficacy of ET140202 T cells by overall response rate (ORR) using Response Evaluation Criteria In Solid Tumors (RECIST).', 'timeFrame': 'up to 2 years', 'description': 'As a measure of activity, overall response rate will be assessed by radiographic scans and assessed according to RECIST criteria.'}, {'measure': 'Assess efficacy of ET140202 T cells by complete response (CR) using Response Evaluation Criteria In Solid Tumors (RECIST).', 'timeFrame': 'up to 2 years', 'description': 'As a measure of activity, CR rate will be assessed by radiographic scans and assessed according to RECIST criteria.'}, {'measure': 'Assess efficacy of ET140202 T cells by partial response (PR) using Response Evaluation Criteria In Solid Tumors (RECIST).', 'timeFrame': 'up to 2 years', 'description': 'As a measure of activity, PR rate will be assessed by radiographic scans and assessed according to RECIST criteria.'}, {'measure': 'Assess efficacy of ET140202 T cells by progression-free survival (PFS) using Response Evaluation Criteria In Solid Tumors (RECIST).', 'timeFrame': 'up to 2 years', 'description': 'As a measure of activity, PFS rate will be assessed by radiographic scans and assessed according to RECIST criteria.'}, {'measure': 'Assess efficacy of ET140202 T cells by overall survival (OS) using Response Evaluation Criteria In Solid Tumors (RECIST).', 'timeFrame': 'up to 2 years', 'description': 'As a measure of activity, OS rate will be assessed by radiographic scans and assessed according to RECIST criteria.'}, {'measure': 'Assess the expansion of ET140202 T cells in the blood shortly after infusion.', 'timeFrame': 'up to 2 years', 'description': 'The maximum (peak) expansion of ET140202 T cells in the blood post infusion will be determined.'}, {'measure': 'Assess the persistence of ET140202 T cells circulating in blood over time.', 'timeFrame': 'up to 2 years', 'description': 'The level of ET140202 T cells in blood will be determined to assess the persistence of ET140202 T cells during the treatment and follow-up phases of the study.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hepatocellular Carcinoma', 'HCC', 'Advanced HCC', 'Late-Stage HCC', 'Liver Cancer', 'Liver Neoplasm', 'Metastatic Liver Cancer', 'Metastatic HCC', 'T-cell therapy', 'Immunotherapy'], 'conditions': ['Hepatocellular Carcinoma', 'Liver Cancer', 'Liver Neoplasm', 'Metastatic Liver Cancer']}, 'descriptionModule': {'briefSummary': 'This is a open-label, dose escalation, multi-center, Phase I / Phase II study to assess the safety of an autologous T-cell product (ET140202) in adult subjects with advanced Alpha-fetoprotein (AFP) positive/Human Leukocyte Antigen (HLA) A-2 positive Hepatocellular Carcinoma (HCC).', 'detailedDescription': 'The purpose of this study is to investigate a genetically modified autologous T-cell therapy for advanced hepatocellular carcinoma (HCC). ET140202 T cells are autologous T cells genetically modified to carry a TCR-mimic (TCRm) construct capable of mediating cell killing by targeting tumor specific intracellular antigens and addressing solid tumor therapy challenges.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Signed written informed consent obtained prior to study procedures\n* Histologically confirmed HCC with serum AFP \\>200ng/ml at time of screening and following most current line of therapy OR radiographic diagnosis of HCC with serum AFP \\>400ng/ml at time of screening and following most current line of therapy..\n* Metastatic or locally advanced, unresectable HCC\n* Must have failed or not tolerated, at least one line of systemic therapy for advanced HCC\n* Molecular Human Leukocyte Antigen ("HLA") class I allele typing confirms participant carries at least one HLA-A2 allele\n* Life expectancy of at least 4 months\n* Karnofsky Performance Scale greater than or equal to 70\n* At least 1 measurable lesion on imaging by RECIST\n* Child-Pugh A or B7\n* Absolute neutrophil count greater than or equal to 1,500/mm\\^3\n* Platelet count greater than or equal to 30,000/mm\\^3\n\nExclusion Criteria:\n\n* Clinically significant cardiac disease\n* Clinically significant pre-existing illness or active infection\n* Clinically significant Central Nervous System (CNS) or neural dysfunction\n* Active autoimmune disease requiring therapy\n* Active malignancy other than HCC unless expected survival is greater than or equal to three years without any treatment (exception: hormone/androgen-depravation therapy) and without any organ involvement\n* History of organ transplant\n* Compromised circulation in portal vein, hepatic vein, or vena cava due to obstruction\n* Advanced HCC involving greater than one-third of the liver'}, 'identificationModule': {'nctId': 'NCT03998033', 'acronym': 'ET-109', 'briefTitle': 'Study of ET140202 T Cells in Adults With Advanced Hepatocellular Carcinoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Eureka Therapeutics Inc.'}, 'officialTitle': 'An Open-Label, Dose Escalation, Multi-Center Phase I/II Research Trial to Assess the Safety of ET140202 T Cells and Determine the Recommended Phase II Dose ("RP2D") in Adults With Advanced Hepatocellular Carcinoma ("HCC")', 'orgStudyIdInfo': {'id': 'ETUS18AFPAR109'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ET140202 T cells', 'description': 'ET140202 Receptor (+) T Cells', 'interventionNames': ['Biological: ET140202 autologous T cell product']}], 'interventions': [{'name': 'ET140202 autologous T cell product', 'type': 'BIOLOGICAL', 'description': 'Autologous T cells transduced with lentivirus encoding an ET140202 expression construct', 'armGroupLabels': ['ET140202 T cells']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '92697', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'UC Irvine', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'UC Davis', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'overallOfficials': [{'name': 'Eureka Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Eureka Therapeutics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eureka Therapeutics Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}