Nctid:
NCT06617000
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-03"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000006506", "term"=>"Hepatitis A"}, {"id"=>"D000006509", "term"=>"Hepatitis B"}, {"id"=>"D000002277", "term"=>"Carcinoma"}, {"id"=>"D000006528", "term"=>"Carcinoma, Hepatocellular"}, {"id"=>"D000006505", "term"=>"Hepatitis"}], "ancestors"=>[{"id"=>"D000009375", "term"=>"Neoplasms, Glandular and Epithelial"}, {"id"=>"D000009370", "term"=>"Neoplasms by Histologic Type"}, {"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000008107", "term"=>"Liver Diseases"}, {"id"=>"D000004066", "term"=>"Digestive System Diseases"}, {"id"=>"D000006525", "term"=>"Hepatitis, Viral, Human"}, {"id"=>"D000014777", "term"=>"Virus Diseases"}, {"id"=>"D000007239", "term"=>"Infections"}, {"id"=>"D000004769", "term"=>"Enterovirus Infections"}, {"id"=>"D000010850", "term"=>"Picornaviridae Infections"}, {"id"=>"D000012327", "term"=>"RNA Virus Infections"}, {"id"=>"D000000230", "term"=>"Adenocarcinoma"}, {"id"=>"D000008113", "term"=>"Liver Neoplasms"}, {"id"=>"D000004067", "term"=>"Digestive System Neoplasms"}, {"id"=>"D000009371", "term"=>"Neoplasms by Site"}, {"id"=>"D000086982", "term"=>"Blood-Borne Infections"}, {"id"=>"D000003141", "term"=>"Communicable Diseases"}, {"id"=>"D000018347", "term"=>"Hepadnaviridae Infections"}, {"id"=>"D000004266", "term"=>"DNA Virus Infections"}], "browseLeaves"=>[{"id"=>"M5534", "name"=>"Carcinoma", "asFound"=>"Carcinoma", "relevance"=>"HIGH"}, {"id"=>"M9613", "name"=>"Carcinoma, Hepatocellular", "asFound"=>"Hepatocellular Carcinoma", "relevance"=>"HIGH"}, {"id"=>"M17522", "name"=>"Virus Diseases", "relevance"=>"LOW"}, {"id"=>"M9595", "name"=>"Hepatitis B", "asFound"=>"Hepatitis B", "relevance"=>"HIGH"}, {"id"=>"M9592", "name"=>"Hepatitis A", "asFound"=>"Hepatitis", "relevance"=>"HIGH"}, {"id"=>"M9591", "name"=>"Hepatitis", "asFound"=>"Hepatitis", "relevance"=>"HIGH"}, {"id"=>"M12320", "name"=>"Neoplasms, Glandular and Epithelial", "relevance"=>"LOW"}, {"id"=>"M12315", "name"=>"Neoplasms by Histologic Type", "relevance"=>"LOW"}, {"id"=>"M11107", "name"=>"Liver Diseases", "relevance"=>"LOW"}, {"id"=>"M8883", "name"=>"Gastrointestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M7255", "name"=>"Digestive System Diseases", "relevance"=>"LOW"}, {"id"=>"M9610", "name"=>"Hepatitis, Viral, Human", "relevance"=>"LOW"}, {"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M7930", "name"=>"Enterovirus Infections", "relevance"=>"LOW"}, {"id"=>"M13745", "name"=>"Picornaviridae Infections", "relevance"=>"LOW"}, {"id"=>"M15149", "name"=>"RNA Virus Infections", "relevance"=>"LOW"}, {"id"=>"M3585", "name"=>"Adenocarcinoma", "relevance"=>"LOW"}, {"id"=>"M11113", "name"=>"Liver Neoplasms", "relevance"=>"LOW"}, {"id"=>"M8886", "name"=>"Gastrointestinal Neoplasms", "relevance"=>"LOW"}, {"id"=>"M7256", "name"=>"Digestive System Neoplasms", "relevance"=>"LOW"}, {"id"=>"M2593", "name"=>"Blood-Borne Infections", "relevance"=>"LOW"}, {"id"=>"M20487", "name"=>"Hepadnaviridae Infections", "relevance"=>"LOW"}, {"id"=>"M7442", "name"=>"DNA Virus Infections", "relevance"=>"LOW"}, {"id"=>"T2787", "name"=>"Herpes Simiae (B Virus)", "asFound"=>"B Virus", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}, {"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE1"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>38}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2022-10-25", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2025-12-31", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-09-25", "studyFirstSubmitDate"=>"2024-09-23", "studyFirstSubmitQcDate"=>"2024-09-25", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-12-31", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Incidence of dose-limiting toxicity (DLT) and adverse events (AEs), including serious AEs (SAEs), cytokine release syndrome (CRS), and immune effector cell-associated neurotoxicity syndrome (ICANS).", "timeFrame"=>"Start of SCG101 infusion until disease progression or 12 months post infusion", "description"=>"Based on incidence of adverse events (AE) using NCI-CTCAE v5.0 and ASTCT criteria"}, {"measure"=>"The preliminary clinical efficacy of SCG101, including objective response rate (ORR), disease control rate (DCR), duration of response (DoR), time to response (TTR), progression-free survival (PFS), and overall survival (OS).", "timeFrame"=>"Start of SCG101 infusion until disease progression or 12 months post infusion", "description"=>"Per mRECIST and iRECIST"}, {"measure"=>"Change in pharmacodynamics markers (PD) before and after SCG101 infusion", "timeFrame"=>"Start of SCG101 infusion until disease progression, an average of 24 months", "description"=>"Based on changes in serum liver function markers, including HBsAg, ALT, AST, and AFP"}, {"measure"=>"Persistences of viral vector copy number (VCN) after SCG101 infusion", "timeFrame"=>"Start of SCG101 infusion until disease progression, an average of 24 months"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["HCC", "Hepatitis B Virus Related Hepatocellular Carcinoma", "Hepatocellular Carcinoma"]}, "descriptionModule"=>{"briefSummary"=>"This is a Phase I clinical study aimed to assess the safety, tolerability, and efficacy of SCG101 monotherapy for patients with HBV-HCC."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"70 years", "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Histologically or cytologically confirmed Hepatocellular carcinoma (HCC)\n* Subjects with HCC who have received standard systemic therapies\n* HLA-A \\*02\n* BCLC stage B or C\n* Child-pugh score ≤ 7 ol\n* Serum HBeAg negative, serum (or tumor tissue) HBsAg positive, and serum HBV-DNA must be ≤ 1 × 1000 IU/ml\n* Have at least one measurable leasion at baseline as per mRECIST and iRECIST\n* Life expectancy of 3 months or greater\n* The organ function is in good condition.\n\nExclusion Criteria:\n\n* Subjects with history of another primary cancer within 5 years\n* Central nervous system metastasis and clinically significant central nervous system disease\n* Previous or current coexistence of hepatic encephalopathy\n* Currently present with symptomatic third space fluid accumulation\n* Hypertension that is poorly controlled, as determined by researchers (i.e., arterial hypertension that remains uncontrolled despite standard treatment)\n* Known history of neurological or mental disorder, including epilepsy or dementia\n* Suffering from active autoimmune diseases, or other significant ongoing immune rejection based on pathology and clinical diagnosis\n* Prior exposure to any cell therapy such as, but not limited to killer (NK) cells, cytokine-induced killer (CIK) cells, dendritic cells (DC), cytotoxic T lymphocytes (CTL), stem cell therapy\n* Positive for HCV - RNA test or positive for HAV IgM antibody or positive for HDV IgM antibody; or there is current evidence indicating the presence of HEV infection\n* Allergy to immunotherapy drugs and lymphodepleting chemotherapy (cyclophosphamide and fludarabine)\n* Any condition which, in the investigator's opinion, makes the subject unsuitable for trial participation"}, "identificationModule"=>{"nctId"=>"NCT06617000", "briefTitle"=>"A Study of SCG101 TCR-T Cell Therpay in the Treatment of Subjects With Hepatitis B Virus-Related", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"SCG Cell Therapy Pte. Ltd."}, "officialTitle"=>"A Phase 1, Multicenter Study of SCG101 in the Treatment of Subjects With Hepatitis B Virus-Related Hepatocellular Carcinoma", "orgStudyIdInfo"=>{"id"=>"SCG-101-CR-102"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"SCG101", "interventionNames"=>["Biological: SCG101"]}], "interventions"=>[{"name"=>"SCG101", "type"=>"BIOLOGICAL", "description"=>"Infusion of HBsAg-specific TCR autologous T cells at assigned dose levels.", "armGroupLabels"=>["SCG101"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"100020", "city"=>"Beijing", "state"=>"Beijing", "status"=>"RECRUITING", "country"=>"China", "facility"=>"Beijing", "geoPoint"=>{"lat"=>39.9075, "lon"=>116.39723}}, {"zip"=>"510000", "city"=>"Guangzhou", "state"=>"Guangdong", "status"=>"RECRUITING", "country"=>"China", "facility"=>"Guangzhou", "geoPoint"=>{"lat"=>23.11667, "lon"=>113.25}}, {"zip"=>"450003", "city"=>"Zhengzhou", "state"=>"Henan", "status"=>"RECRUITING", "country"=>"China", "facility"=>"Zhengzhou", "geoPoint"=>{"lat"=>34.75778, "lon"=>113.64861}}, {"zip"=>"130000", "city"=>"Chang chun", "state"=>"Jilin", "status"=>"RECRUITING", "country"=>"China", "facility"=>"Changchun", "geoPoint"=>{"lat"=>42.74694, "lon"=>126.24667}}, {"zip"=>"110000", "city"=>"Shenyang", "state"=>"Liaoning", "status"=>"RECRUITING", "country"=>"China", "facility"=>"Shenyang", "geoPoint"=>{"lat"=>41.79222, "lon"=>123.43278}}, {"zip"=>"250000", "city"=>"Ji'nan", "state"=>"Shandong", "status"=>"RECRUITING", "country"=>"China", "facility"=>"Ji'nan", "geoPoint"=>{"lat"=>36.66833, "lon"=>116.99722}}, {"zip"=>"200000", "city"=>"Shanghai", "state"=>"Shanghai", "status"=>"RECRUITING", "country"=>"China", "facility"=>"Shanghai", "geoPoint"=>{"lat"=>31.22222, "lon"=>121.45806}}], "centralContacts"=>[{"name"=>"SCG Cell Therapy", "role"=>"CONTACT", "email"=>"clinicaltrials@scgcell.com", "phone"=>"021-50339500"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"SCG Cell Therapy Pte. Ltd.", "class"=>"INDUSTRY"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
