Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2026-03-10 @ 11:28 PM
Study NCT ID:
NCT03322735
Status:
UNKNOWN
Last Update Posted:
2017-12-29
First Post:
2017-10-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of BCMA CAR-T in Multiple Myeloma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C024352', 'term': 'fludarabine'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}], 'ancestors': [{'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-12-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-12-28', 'studyFirstSubmitDate': '2017-10-19', 'studyFirstSubmitQcDate': '2017-10-23', 'lastUpdatePostDateStruct': {'date': '2017-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Treatment-Emergent Adverse Events', 'timeFrame': '1 year', 'description': 'number of participants with adverse events'}], 'secondaryOutcomes': [{'measure': 'Persistence of the BCMA CAR+ T cells', 'timeFrame': '1 year', 'description': 'determine duration of in vivo survival of BCMA CAR-T cells'}, {'measure': 'anti-tumor responses of BCMA CAR-T cells', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Myeloma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to infusion BCMA CAR-T cells to the patients with relapsed and refractory multiple myeloma(MM), to assess the safety and feasibility of this strategy. The CAR enables the T cell to recognize and kill the MM cells through the recognition of BCMA, a protein expressed of the surface of the malignant plasma cells in MM patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. 18 years to 70 years, expected survival \\> 3 months;\n* 2\\. Confirmed diagnosis of active MM as defined by IMWG. BCMA expression of the malignant cells must be detected by immunohistochemistry or by flow cytometry.\n* 3\\. BCMA-expressing B cell malignancy must be assured and must be relapsed or refractory disease.；\n* 4\\. ECOG performance status of 0-2;\n* 5\\. Cardiac function: 1-2 levels; Liver: TBIL≤3ULN，AST ≤2.5ULN，ALT ≤2.5ULN; kidney: Cr≤1.25ULN;\n* 6\\. No serious allergic constitution;\n* 7\\. No other serous diseases that conflicts with the clinical program;\n* 8\\. No other cancer history;\n* 9\\. female participants of reproductive potential must have a negative serum pregnancy test;\n* 10\\. Subjects must have signed written, informed consent.\n\nExclusion Criteria:\n\n* 1\\. Pregnant or lactating women;\n* 2\\. Uncontrolled active infection, HIV infection, syphilis serology reaction positive;\n* 3\\. Active hepatitis B or hepatitis C infection;\n* 4\\. Recent or current use of glucocorticoid or other immunosuppressor;\n* 5\\. serious mental disorder;\n* 6\\. With severe cardiac, liver, renal insufficiency, diabetes and other diseases;\n* 7\\. Participate in other clinical research in the past three months; previously treatment with any gene therapy products;'}, 'identificationModule': {'nctId': 'NCT03322735', 'briefTitle': 'Study of BCMA CAR-T in Multiple Myeloma', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Henan Cancer Hospital'}, 'officialTitle': 'A Study of BCMA CAR-T Cells for Patients With Relapse and Refractory Multiple Myeloma', 'orgStudyIdInfo': {'id': 'HenanCH284'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'anti-tumor response of BCMA CAR-T', 'description': 'Drug: Cyclophosphamide patients will receive a standard pre-conditioning regime with cyclophosphamide 0.6-0.8g/m2/day IV for 2 days.\n\nDrug: Fludarabine Fludarabine 25-30mg/m2/day IV for 3 days. Biological: BCMA CAR-T BCMA CAR-T cells will be administered after completion of the chemotherapy.', 'interventionNames': ['Drug: Fludarabine', 'Drug: Cyclophosphamide', 'Biological: BCMA CAR-T']}], 'interventions': [{'name': 'Fludarabine', 'type': 'DRUG', 'description': '25-30mg/m2/day IV for 3 days', 'armGroupLabels': ['anti-tumor response of BCMA CAR-T']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'description': 'cyclophosphamide 0.6-0.8g/m2/day IV for 2 days', 'armGroupLabels': ['anti-tumor response of BCMA CAR-T']}, {'name': 'BCMA CAR-T', 'type': 'BIOLOGICAL', 'description': 'BCMA CAR-T cells will be administered after completion of the chemotherapy.', 'armGroupLabels': ['anti-tumor response of BCMA CAR-T']}]}, 'contactsLocationsModule': {'locations': [{'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', 'role': 'CONTACT', 'email': 'ph200811@163.com', 'phone': '+86-13521186987'}], 'overallOfficials': [{'name': 'Yongping Song', 'role': 'PRINCIPAL_INVESTIGATOR', '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'}}}}