Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-01-08 @ 6:03 AM
Study NCT ID:
NCT03940833
Status:
UNKNOWN
Last Update Posted:
2019-05-07
First Post:
2019-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Research of Adoptive BCMA CAR-NK Cells on Relapse/Refractory MM
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2022-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-05-05', 'studyFirstSubmitDate': '2019-05-05', 'studyFirstSubmitQcDate': '2019-05-05', 'lastUpdatePostDateStruct': {'date': '2019-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Occurrence of treatment related adverse events as assessed by CTCAE v4.03', 'timeFrame': '1 year', 'description': 'Defined as \\>= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Myeloma']}, 'referencesModule': {'references': [{'pmid': '34471234', 'type': 'DERIVED', 'citation': 'Ng YY, Du Z, Zhang X, Chng WJ, Wang S. CXCR4 and anti-BCMA CAR co-modified natural killer cells suppress multiple myeloma progression in a xenograft mouse model. Cancer Gene Ther. 2022 May;29(5):475-483. doi: 10.1038/s41417-021-00365-x. Epub 2021 Sep 1.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to infuse BCMA CAR-NK 92 cells to the patients with relapsed and refractory multiple myeloma (MM), to assess the safety and feasibility of this strategy. The CAR enables the NK-92 cells to recognize and kill the MM cells by targeting of BCMA, a protein expressed of the surface of the malignant plasma cells in MM patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18 years to 80 years, expected survival \\> 3 months\n2. Confirmed diagnosis of active MM as defined by IMWG. BCMA expression of the malignant cells must be detected by immunohistochemistry or by flow cytometry\n3. BCMA-expressing B cell malignancy must be assured and must be relapsed or refractory disease\n4. ECOG performance status of 0 - 1\n5. Cardiac function: 1 - 2 levels; Liver: TBIL ≤ 3ULN，AST ≤ 2.5 ULN，ALT ≤ 2.5ULN; kidney: Cr ≤ 1.25ULN\n6. No serious allergic constitution\n7. No other serous diseases that conflicts with the clinical program\n8. No other cancer history\n9. Female participants of reproductive potential must have a negative serum pregnancy test\n10. Subjects must have signed written, informed consent\n\nExclusion Criteria:\n\n1. Pregnant or lactating women\n2. Uncontrolled active infection, HIV infection, syphilis serology reaction positive\n3. Active hepatitis B or hepatitis C infection\n4. Recent or current use of glucocorticoid or other immunosuppressor\n5. Serious mental disorder\n6. With severe cardiac, liver, renal insufficiency, diabetes and other diseases\n7. Participate in other clinical research in the past three months\n8. Previously treatment with any gene therapy products'}, 'identificationModule': {'nctId': 'NCT03940833', 'briefTitle': 'Clinical Research of Adoptive BCMA CAR-NK Cells on Relapse/Refractory MM', 'organization': {'class': 'INDUSTRY', 'fullName': 'Asclepius Technology Company Group (Suzhou) Co., Ltd.'}, 'officialTitle': 'Clinical Research of Adoptive BCMA CAR-NK Cells on Relapse/Refractory MM', 'orgStudyIdInfo': {'id': 'AsclepiusTCG02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'anti-tumor response of BCMA CAR-NK-92', 'description': 'Patients with relapsed and refractory MM of BCMA expression will be treated with BCMA CAR-NK 92 cells.', 'interventionNames': ['Biological: BCMA CAR-NK 92 cells']}], 'interventions': [{'name': 'BCMA CAR-NK 92 cells', 'type': 'BIOLOGICAL', 'description': 'The subject will be observed for any side effects during this time and all the adverse events will be recorded.', 'armGroupLabels': ['anti-tumor response of BCMA CAR-NK-92']}]}, 'contactsLocationsModule': {'locations': [{'zip': '214000', 'city': 'Wuxi', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xin Zhou, PhD', 'role': 'CONTACT', 'email': '13358111962@qq.com'}], 'facility': "Department of Hematology, Wuxi People's Hospital, Nanjing Medical University", 'geoPoint': {'lat': 31.56887, 'lon': 120.28857}}], 'centralContacts': [{'name': 'Guangfu Li', 'role': 'CONTACT', 'email': 'lgf@atcgcell.com', 'phone': '+86 13615181959'}, {'name': 'Xianfeng Feng', 'role': 'CONTACT', 'email': 'fxf@atcgcell.com', 'phone': '+86 15157190521'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asclepius Technology Company Group (Suzhou) Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}