Ignite Creation Date:
2025-12-24 @ 12:19 PM
Ignite Modification Date:
2025-12-24 @ 12:19 PM
Study NCT ID:
NCT03881761
Status:
UNKNOWN
Last Update Posted:
2019-03-21
First Post:
2019-03-16
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CD19/20 Bispecific Nanobody-derived CAR-T Cells in B Cell Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'transfusion of CD19/CD20 bispecific CAR-T cells 24-72 hours after completion of FC regimen pretreatment'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2022-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-19', 'studyFirstSubmitDate': '2019-03-16', 'studyFirstSubmitQcDate': '2019-03-16', 'lastUpdatePostDateStruct': {'date': '2019-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'occurrence of study related adverse events', 'timeFrame': 'one year', 'description': 'safety of CAR-T cells'}], 'secondaryOutcomes': [{'measure': 'objective response rate', 'timeFrame': 'three months', 'description': 'proportion of patients with complete response and partial response'}, {'measure': 'survival time of CAR-T cells in vivo', 'timeFrame': 'one year', 'description': 'from the time of CAR-T cells transfusion to the first time that CAR-T cells could not be measured in vivo'}, {'measure': 'progression-free survival', 'timeFrame': 'one year', 'description': 'the enrollment to the first time that disease progression is detected'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['B-Cell Lymphoma Stage I', 'Refractory', 'Relapsed']}, 'descriptionModule': {'briefSummary': 'Evaluation the safety and efficacy of CD19/CD20 bispecific CAR-T cells in patients with relapsed/refractory B cell lymphoma', 'detailedDescription': 'CART cell therapy has become the treatment of choice for patients with relapsed/ refractory B cell lymphoma. Currently, CAR-T cells approved for relapsed/refractory B-cell lymphoma are mainly CAR19-T cells. Nearly half of patients who relapse after treatment with CAR19-T cells are caused by tumor cell antigen escape. Dual-target CAR-T cells targeting CD19 and CD20 may reduce the recurrence rate after treatment. This study was to evaluate the efficacy and safety of CD19/CD20 bispecific CAR-T cells in patients with relapsed/refractory B cell lymphoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* expected lifetime\\>3 months\n* CD19/CD20 positive relapsed/refractory B cell lymphoma\n* KPS\\>70\n* at least one measurable lesion according to RECIST 1.1\n* enough function of hear, liver, kidney and bone marrow\n* no history of severe allergies\n* no other history of malignancy\n* no other diseases that conflict with this regimen\n* no serious mental illness\n* patient or family member sign informed consent\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* Severe infectious or viral disease\n* Active B or C viral hepatitis\n* Patients who have used large amounts of glucocorticoids or other immunosuppressive agents during the last 4 weeks\n* participated in other clinical studies in the last 3 months, or have been treated with other gene products\n* Others not appropriate to participate in this study examined by the investigators'}, 'identificationModule': {'nctId': 'NCT03881761', 'briefTitle': 'CD19/20 Bispecific Nanobody-derived CAR-T Cells in B Cell Lymphoma', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Henan Cancer Hospital'}, 'officialTitle': 'Clinical Study of CD19/CD20 Bispecific Nanobody-derived CAR-T Cells in Refractroy/Relasped B Cell Lymphoma', 'orgStudyIdInfo': {'id': 'HenanCH CART 2-3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'experimental arm', 'description': 'CAR-T cell group', 'interventionNames': ['Biological: CD19/CD20 bispecific CAR-T cells']}], 'interventions': [{'name': 'CD19/CD20 bispecific CAR-T cells', 'type': 'BIOLOGICAL', 'description': 'collecting blood for CAR-T cells culture three days later, FC regimen (fludarabine 30mg/m2/d x 3, cyclophosphamide 600-800mg/m2/d x 2) another two days later, transfusing CD19/CD20 bispecific CAR-T cell with a dose of 1-3x106/kg', 'armGroupLabels': ['experimental arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '450000', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yongping Song, Dr.', 'role': 'CONTACT', 'email': 'songyongping2018@126.com', 'phone': '+86-37165587795'}, {'name': 'Quanli Gao, Dr.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Cancer Hospital Affiliate to Zhengzhou University & Henan Cancer Hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}, {'zip': '450000', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Quanli Gao, M.D', 'role': 'CONTACT', 'email': 'gaoquanli2015@126.com', 'phone': '+86-15038171966'}, {'name': 'Lu Han, M.D', 'role': 'CONTACT', 'email': 'luhan0377@163.com', 'phone': '+86-13838583031'}], 'facility': 'Henan Cancer Hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'centralContacts': [{'name': 'Yongping Song, Dr.', 'role': 'CONTACT', 'email': 'songyongping2018@126.com', 'phone': '+86-37165587795'}, {'name': 'Quanli Gao, Dr.', 'role': 'CONTACT', 'email': 'gaoquanli2015@126.com', 'phone': '+86-37165587483'}], 'overallOfficials': [{'name': 'Yongping Song, Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'Henan Cancer Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henan Cancer Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Henan Hualong Biotechnology Company', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}