Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2026-03-01 @ 2:05 AM
Study NCT ID:
NCT03271632
Status:
UNKNOWN
Last Update Posted:
2019-09-19
First Post:
2017-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multi-CAR T Cell Therapy in the Treatment of 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': 'D016219', 'term': 'Immunotherapy, Adoptive'}], 'ancestors': [{'id': 'D019264', 'term': 'Adoptive Transfer'}, {'id': 'D007116', 'term': 'Immunization, Passive'}, {'id': 'D007114', 'term': 'Immunization'}, {'id': 'D007167', 'term': 'Immunotherapy'}, {'id': 'D056747', 'term': 'Immunomodulation'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, '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': '2017-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-09-18', 'studyFirstSubmitDate': '2017-08-27', 'studyFirstSubmitQcDate': '2017-08-31', 'lastUpdatePostDateStruct': {'date': '2019-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients with treatment related adverse effect', 'timeFrame': '1 month', 'description': 'percentage of participants with treatment-related adverse events, as assessed by physical exam, vital signs, standard clinical lab tests.'}], 'secondaryOutcomes': [{'measure': 'Anti-tumor activity of fourth generation multiple CAR-T cells after infusion', 'timeFrame': '1 year', 'description': 'by measuring CAR copies in the body'}, {'measure': 'Anti-tumor activity of fourth generation multiple CAR-T cells in patients with relapsed or refractory MM', 'timeFrame': '1 year', 'description': 'by physical examination of tumor burden'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['multiple myeloma', 'chimeric antigen receptor', 'BCMA', 'CD38', 'CD56', 'CD138'], 'conditions': ['Multiple Myeloma']}, 'descriptionModule': {'briefSummary': 'The aim of this clinical trial is to assess the feasibility, safety and efficacy of autologous CAR T cell immunotherapy targeting multiple cancer cell surface antigens in relapsed and refractory multiple myeloma patients. Another goal of the study is to learn more about the persistence and function of CAR T cells in the body.', 'detailedDescription': 'Multiple myeloma (MM) is a malignancy of plasma cells, which remains a clinical challenge despite advanced therapeutic interventions including novel molecular therapies and stem cell transplantation (SCT). This trial is to test the safety and efficacy of T cells genetically modified to specifically target several MM surface antigens, including BCMA, CD38, CD56, CD138 or alternative MM surface antigens, based on a multi-CAR T cell immunotherapy approach. Another goal of the study is to investigate the persistence and function of CAR T cells in the body after CAR T cell infusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female subjects with surface antigen confirmed multiple myeloma with no available curative treatment options (including autologous or allogeneic SCT).\n* Complete remission (CR) cannot be achieved after at least 4 prior combination therapy regimens.\n* MM in CR2 or CR3 and not eligible for allogeneic SCT because of age, comorbid diseases, or lack of available donor.\n* Less than 1 year between last chemotherapy and progression (i.e. most recent progression free interval \\< 1 year).\n* Relapsed after prior autologous or allogenic SCT MM patients with relapsed or residual disease after at least 1 prior therapy and not eligible for allogeneic SCT.\n* Residual disease after primary therapy and not eligible for ASCT\n* Expected survival \\> 12 weeks\n* Creatinine \\< 2.5 mg/dl\n* ALT (alanine aminotransferase)/AST (aspartate aminotransferase) \\< 3x normal\n* Bilirubin \\< 2.0 mg/dl\n* Any relapse after prior SCT is eligible regardless of other prior therapy\n* Adequate venous access for apheresis, and no other contraindications for leukapheresis\n* Voluntary informed consent is given\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* Uncontrolled active infection\n* Active hepatitis B or hepatitis C infection\n* Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.\n* Previous related CAR-T cell therapy Any uncontrolled active medical disorder that would preclude participation\n* HIV infection'}, 'identificationModule': {'nctId': 'NCT03271632', 'briefTitle': 'Multi-CAR T Cell Therapy in the Treatment of Multiple Myeloma', 'organization': {'class': 'OTHER', 'fullName': 'Shenzhen Geno-Immune Medical Institute'}, 'officialTitle': 'Multiple Antigen-specific CAR T Cells For the Treatment of Multiple Myeloma', 'orgStudyIdInfo': {'id': 'GIMI-IRB-17013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single arm', 'description': 'CAR T cells to treat MM', 'interventionNames': ['Biological: CAR T cells']}], 'interventions': [{'name': 'CAR T cells', 'type': 'BIOLOGICAL', 'description': 'Infusion of multi-CAR T cells', 'armGroupLabels': ['Single arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '518000', 'city': 'Shenzhen', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lung-Ji Chang, PhD', 'role': 'CONTACT', 'email': 'c@szgimi.org', 'phone': '86-075586725195'}], 'facility': 'Shenzhen Geno-immune Medical Institute', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'zip': '650000', 'city': 'Kunming', 'state': 'Yunnan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xun Lai, Master', 'role': 'CONTACT', 'email': '1729112214@qq.com', 'phone': '13577096609'}], 'facility': "The First People's Hospital of Yunnan", 'geoPoint': {'lat': 25.03889, 'lon': 102.71833}}], 'centralContacts': [{'name': 'Lung-Ji Chang', 'role': 'CONTACT', 'email': 'c@szgimi.org', 'phone': '86-075586725195'}], 'overallOfficials': [{'name': 'Lung-Ji Chang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shenzhen Geno-Immune Medical Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shenzhen Geno-Immune Medical Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Lung-Ji Chang', 'investigatorAffiliation': 'Shenzhen Geno-Immune Medical Institute'}}}}