Ignite Creation Date:
2025-12-24 @ 11:51 AM
Ignite Modification Date:
2026-04-13 @ 9:31 PM
Study NCT ID:
NCT03664661
Status:
UNKNOWN
Last Update Posted:
2018-09-10
First Post:
2018-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BCMA-CAR-T in Relapsed/Refractory Multiple Myeloma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-04-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2020-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-07', 'studyFirstSubmitDate': '2018-09-06', 'studyFirstSubmitQcDate': '2018-09-07', 'lastUpdatePostDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'occurrence of study related adverse events', 'timeFrame': '4 weeks', 'description': 'safety of CAR-T cells'}], 'secondaryOutcomes': [{'measure': 'Treatment response rate', 'timeFrame': '3 months and 6 months', 'description': 'response rate according to IMWG criteria'}, {'measure': 'copy number of CAR-T cells', 'timeFrame': 'one year', 'description': 'copy number of CAR-T cells'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Relapsed/Refractory Myeloma']}, 'descriptionModule': {'briefSummary': 'Evaluation of the safety and efficacy of BCMA nanobody CAR-T cells in relapsed/refractory myeloma', 'detailedDescription': 'There are no effective regimens for relapsed/refractory myeloma. BCMA express extensively in mature B cells and plasma cells. Myeloma cells express BCMA universally. BCMA signal pathway can induce plasma cell proliferation and survival, down-regulation of BCMA could control the progression of myeloma. The BCMA CAR used in this study consists of BCMA nanobody, CD8 hinge, transmembrane region and 4-1bb co-stimulation domain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 and ≤70 years old and the expected lifetime \\>3 months\n\n * Active myeloma according to IMWG criteria, and BCMA positive by immunohistochemistry or flow cytometry\n * No effective treatment option available\n * ECOG score 0-2\n * Sufficient heart, liver, kidney function (heart: no heart disease or coronary heart disease, patient heart function NYHA grade 1-2; liver: TBIL ≤ 3ULN, AST ≤ 2.5ULN, ALT ≤ 2.5ULN; kidney: Cr≤ 1.25ULN);\n * smoothly peripheral superficial veins\n * No other serious diseases that conflict with this protocol (eg, autoimmune diseases, immunodeficiency, organ transplantation)\n * No history of other malignancies\n * Women of childbearing age must be negative for blood pregnancy test within 7 days and must take appropriated contraceptive measures during and 3 months after the study\n * The patient himself agrees to participate in this clinical study and signed the "informed consent"\n\nExclusion Criteria:\n\n* Severe infectious 4 weeks before enrollment\n* Active hepatitis B or C viral hepatitis, HIV,\n* Severe autoimmune disease or immunodeficiency disease\n* Severe allergies\n* Severe mental disorder\n* Patients who used high-dose glucocorticoids within 1 week\n* Participation in other clinical studies in the past 3 months or having been treated with other gene products'}, 'identificationModule': {'nctId': 'NCT03664661', 'briefTitle': 'BCMA-CAR-T in Relapsed/Refractory Multiple Myeloma', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Henan Cancer Hospital'}, 'officialTitle': 'a Single-center, One Arm, Open Clinical Study of BCMA Nanobody CAR-T Cell in Refractory/Relapsed Myeloma', 'orgStudyIdInfo': {'id': 'HenanCH CAR 2-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'experimental group', 'description': 'BCMA nanobody CAR-T cells', 'interventionNames': ['Drug: BCMA nanobody CAR-T cells']}], 'interventions': [{'name': 'BCMA nanobody CAR-T cells', 'type': 'DRUG', 'description': 'step 1: Collect 50-100ml of peripheral blood for culture of BCMA nanobody CAR- T cells. step 2. After 72 hours, pretreated with FC regimen, details as follow Cyclophosphamide 600-800mg/m2 for 2 days Fludarabine 25-30mg/m2 for 3 days. step 3: After another 48 hours transfusion the cells back to the patients the numbers of infused CAR T cells are 5x106 /kg for the first 3 patients, 1.5x107 /kg for the second 3 patients and 4.5x107 /kg for the third 3 patients.\n\nAfter finishing this, another 6 patients will be enrolled for observation of efficacy.', 'armGroupLabels': ['experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '450000', 'city': 'Zhengzhou', 'state': 'Henan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yongping Song', 'role': 'CONTACT', 'email': 'ph200811@163.com', 'phone': '+86-13521186987'}, {'name': 'Yongping Song', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cancer Hospital Affiliate to Zhengzhou University & Henan Cancer Hospital', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'centralContacts': [{'name': 'Yongping Song, M.D', 'role': 'CONTACT', 'email': 'songyongping2018@126.com', 'phone': '+86-371-65587199'}, {'name': 'Quanli Gao, M.D', 'role': 'CONTACT', 'email': 'gaoquanli2015@126.com', 'phone': '+86-15038171966'}], 'overallOfficials': [{'name': 'Yongping Song, M.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Henan Cancer Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henan Cancer Hospital', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'The Pregene (ShenZhen) Biotechnology Company, Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}