Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2026-01-12 @ 10:48 PM
Study NCT ID:
NCT03113058
Status:
UNKNOWN
Last Update Posted:
2017-04-21
First Post:
2017-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
"Treatment of Active HBV With γδT Cells" Clinical Trial Protocol
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-05-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2018-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-19', 'studyFirstSubmitDate': '2017-04-10', 'studyFirstSubmitQcDate': '2017-04-10', 'lastUpdatePostDateStruct': {'date': '2017-04-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DNA copy number', 'timeFrame': '6 months', 'description': 'Whether or not the DNA copy number in patients can be lowered more faster than those do not received T cell treatment in 6 months.'}, {'measure': 'Negative conversion rate of HbeAg', 'timeFrame': '6 months', 'description': 'We will evaluate whether or not γδT Cells treatment could speed up Negative conversion rate of HbeAg.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HBV infection,γδT cells,Adoptive treatment'], 'conditions': ['Adoptive Treatment for Hepatitis B With γδT Cells']}, 'descriptionModule': {'briefSummary': 'To evaluate the safety and anti-HBV efficacy of γδT cells.', 'detailedDescription': 'In this clinical trial, we will thoroughly evaluate the safety of in vitro expanded γδT cells, including allogeneic originated γδT cells, in clinical treatment of active HBV. At the same time, we will carefully and thoroughly examine and evaluate the clinical efficacy of γδT cells against active HBV, including lowering speed of DNA copy number, and the transferring rate of HBeAg from positive to negative.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Aged 18-45 years old, male or female; 2. Informed consent; 3. Patient who were tested HBsAg and HBeAg positive; 4. HBV DNA loads\\>1 million copy/ml;5. Liver function test alanine aminotransferase (ALT) 160 IU/L≤400 IU/L; 6. No jaundice, total bilirubin is normal;7. For patients with new onset, oral antiviral drugs limited for Sebivo.\n\nExclusion Criteria:\n\n* 1\\. Pregnant women;2. Patients Complicated with other viruses, bacteria infections and other infectious diseases;3. With other diseases such as diabetes, cancer, hypertension, coronary heart disease, endocrine system disease, mental illness, neurological disease, vascular circulation system diseases and so on, and after clinical doctors diagnose, evaluate the immune cells are not suitable for treatment of patients;4. There is no immediate relatives, immediate family members suffering from infectious diseases including e antigen positive, or immediate family is not suitable for patients as white blood cells supplier;5. Other indications that is not suitable for the treatment'}, 'identificationModule': {'nctId': 'NCT03113058', 'briefTitle': '"Treatment of Active HBV With γδT Cells" Clinical Trial Protocol', 'organization': {'class': 'OTHER', 'fullName': 'Jinan University Guangzhou'}, 'officialTitle': '"Treatment of HBeAg-positive Chronic Hepatitis B With γδT Cells" Clinical Trial Protocol', 'orgStudyIdInfo': {'id': 'GDT-HBV-01-QK'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'study group', 'interventionNames': ['Combination Product: Adoptive transfer of γδT cells']}], 'interventions': [{'name': 'Adoptive transfer of γδT cells', 'type': 'COMBINATION_PRODUCT', 'description': 'Patients are treated via intravenous infusion of in vitro-activated allogeneic γδ Tcells every two weeks, 12 times in total (6 months).', 'armGroupLabels': ['study group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'contacts': [{'name': 'Ren X Lai, bachelor', 'role': 'CONTACT', 'email': 'huitou_2007@163.com', 'phone': '+86-15920368701'}], 'facility': 'Guagnzhou Qiaokang Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Zhinan Yin, Ph.D.', 'role': 'CONTACT', 'email': 'zhinan.yin@yale.edu', 'phone': '(+86)18818801179'}, {'name': 'Yangzhe Wu, Ph.D.', 'role': 'CONTACT', 'email': '190374157@qq.com', 'phone': '(+86)18826469480'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jinan University Guangzhou', 'class': 'OTHER'}, 'collaborators': [{'name': 'Guagnzhou Qiaokang Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Zhinan Yin, Ph.D.', 'investigatorAffiliation': 'Jinan University Guangzhou'}}}}