Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2026-01-04 @ 12:07 PM
Study NCT ID:
NCT03492268
Status:
WITHDRAWN
Last Update Posted:
2022-05-17
First Post:
2018-04-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Evaluation of BCMA-CART for Treating 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Patients undergo leukapheresis to separate their lymphocytes, from which CART cells are produced. Patients will receive a conditioning therapy with cyclophosphamide and fludarabine before CART therapy. BCMA-CART cells will be injected intravenously (IV) into patients on day 0.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Due to CART processing facility construction', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-15', 'studyFirstSubmitDate': '2018-04-03', 'studyFirstSubmitQcDate': '2018-04-03', 'lastUpdatePostDateStruct': {'date': '2022-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response rate (ORR)', 'timeFrame': 'Up to 90 days after T cell infusion', 'description': 'Proportion of patients in whom a response among complete response or partial response, as defined by International Myeloma Working group(IMWG) response criteria , will be observed.'}], 'secondaryOutcomes': [{'measure': 'Incidence and Severity of Adverse Events as a Measure of Safety', 'timeFrame': 'Baseline up to 35 days', 'description': 'Adverse events assessed according to NCI-CTCAE v4.03 criteria'}, {'measure': 'Duration of persistence of BCMA-CART', 'timeFrame': 'Baseline up to 1 year', 'description': 'BCMA-CART duration be assessed by FACS or QPCR'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Myeloma']}, 'descriptionModule': {'briefSummary': 'This trial aims to evaluate the safety and efficacy of BCMA-CART in treating patients with relapsed or refractory multiple myeloma.', 'detailedDescription': 'BCMA(B-Cell maturation antigen) is a tumor antigen of multiple myeloma . Using a genetic engineering strategy to assemble an anti-BCMA CAR(chimeric antigen receptor) in autologous T cells will help these CART cells to recognize and kill BCMA-expressing MM tumor cells. This trial aims to evaluate the safety and anti-tumor efficacy of autologous BCMA-CART in treating relapsed or treatment refractory multiple myeloma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have the capacity to give informed consent;\n* Confirmed diagnosis of active MM as defined by NCCN and IMWG criteria;\n* Have a diagnosis of BCMA+ multiple myeloma (MM), (≥ 5% BCMA+ in CD138+ plasma cells by flow cytometry obtained within 45 days of study enrollment);\n* Refractory and relapsed MM patients after \\> 2 cycles of induction therapy,or,have relapsed or treatment refractory disease following autologous stem cell transplant (ASCT);\n* ECOG score=0-2.\n\nExclusion Criteria:\n\n* Pregnant or nursing women; Women of reproductive potential must have a negative serum pregnancy test performed within 48 hours of starting conditioning chemotherapy;\n* Active infection, HIV infection, syphilis serology reaction positive;\n* Active hepatitis B, hepatitis C at the time of screening;\n* Significant hepatic dysfunction as following, SGOT(serum glutamic-oxaloacetic transaminase)\\> 5 x upper limit of normal; bilirubin \\> 3.0 mg/dL;\n* Lymphotoxic chemotherapeutic agents within 2 weeks of leukapheresis serious mental disorder;\n* With severe cardiac, liver, renal insufficiency, diabetes and other diseases;\n* Participate in other clinical research in the past three months; previously treatment with any gene therapy products;\n* Contraindication to cyclophosphamide or fludarabine chemotherapy.'}, 'identificationModule': {'nctId': 'NCT03492268', 'briefTitle': 'Safety and Efficacy Evaluation of BCMA-CART for Treating Multiple Myeloma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bioray Laboratories'}, 'officialTitle': 'Safety and Efficacy Evaluation of Autologous BCMA-CART for Treating Relapsed or Refractory Multiple Myeloma', 'orgStudyIdInfo': {'id': '2018-CART-00CH3(1)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BCMA-CART', 'description': 'Autologous T cells transduced to express anti-BCMA chimeric antigen receptor (CAR)', 'interventionNames': ['Biological: BCMA-CART']}], 'interventions': [{'name': 'BCMA-CART', 'type': 'BIOLOGICAL', 'description': 'After a conditioning therapy, each patient will receive a treatment of BCMA-CART originated from their own peripheral blood mononuclear cells', 'armGroupLabels': ['BCMA-CART']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200241', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Bioray Laboratories INC.', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Yunxiao Xu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second Xiangya Hospital of Central South University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bioray Laboratories', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'The First Affiliated Hospital of Zhengzhou University', 'class': 'OTHER'}, {'name': 'Second Xiangya Hospital of Central South University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}