Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-01-01 @ 11:47 PM
Study NCT ID:
NCT04272151
Status:
UNKNOWN
Last Update Posted:
2023-04-18
First Post:
2020-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of BCMA-Targeted CAR-T Therapy for Relapsed/Refractory Multiple Myeloma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}, {'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}], 'ancestors': [{'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': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-16', 'studyFirstSubmitDate': '2020-02-13', 'studyFirstSubmitQcDate': '2020-02-14', 'lastUpdatePostDateStruct': {'date': '2023-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events that related to treatment', 'timeFrame': '2 years', 'description': "Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)"}, {'measure': 'The response rate of BCMA CAR-T treatment in patients with relapse/refractory Multiple Myeloma that treatment by BCMA CAR-T cells therapy', 'timeFrame': '6 months', 'description': 'The response rate of BCMA CAR-T treatment will be recorded and assessed according to the IMWG'}], 'secondaryOutcomes': [{'measure': 'Rate of BCMA CAR-T cells in bone marrow and peripheral blood', 'timeFrame': '2 years', 'description': 'In vivo (bone marrow and peripheral blood) rate of BCMA CAR-T cells were determined by means of flow cytometry'}, {'measure': 'Quantity of BCMA CAR copies in bone marrow and peripheral blood', 'timeFrame': '2 years', 'description': 'In vivo (bone marrow and peripheral blood) quantity of BCMA CAR copies were determined by means of qPCR'}, {'measure': 'Quantity of clonal plasma cells in bone marrow', 'timeFrame': '1 years', 'description': 'In vivo (bone marrow) quantity of clonal plasma cells'}, {'measure': 'Levels of IL-6 in Serum', 'timeFrame': '3 months', 'description': 'In vivo (Serum) quantity of IL-6'}, {'measure': 'Duration of Response (DOR) of BCMA CAR-T treatment in patients with refractory/relapsed Multiple Myeloma', 'timeFrame': '2 years', 'description': 'DOR will be assessed from the first assessment of sCR/CR/VGPR/PR to the first assessment of recurrence or progression of the disease or death from any cause (censored)'}, {'measure': 'Progress-free survival(PFS) of BCMA CAR-T treatment in patients with refractory/relapsed multiple myeloma', 'timeFrame': '2 years', 'description': 'PFS will be assessed from the first CAR-T cell infusion to death from any cause or the first assessment of progression (censored)'}, {'measure': 'Overall survival(OS) of BCMA CAR-T treatment in patients with refractory/relapsed multiple myeloma', 'timeFrame': '2 years', 'description': 'OS will be assessed from the first CAR-T cell infusion to death from any cause (censored)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multiple Myeloma', 'Chimeric Antigen Receptor T cell', 'BCMA'], 'conditions': ['Multiple Myeloma', 'Multiple Myeloma in Relapse', 'Neoplasm, Plasma Cell']}, 'descriptionModule': {'briefSummary': 'This is a single arm study to evaluate the efficacy and safety of BCMA-targeted CAR-T cells therapy for patients with relapsed/refractory Multiple Myeloma.', 'detailedDescription': 'There are limited options for treatment of relapse/refractory Multiple Myeloma. BCMA is expressed on most Multiple Myeloma cells so it is an ideal target for CAR-T. In this study, investigators will evaluate the safety and efficacy of CAR-T targeting BCMA in patients with relapsed/refractory Multiple Myeloma. The primary goal is safety and efficiency assessment, including adverse events and disease status after treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Signed written informed consent\n2. Diagnose as relapsed /refractory multiple myeloma, and meet one of the following conditions:\n\n 1. Failed to standard chemotherapy regimens;\n 2. Relapse after complete remission, high-risk and / or refractory patients ;\n 3. Relapse after hematopoietic stem cell transplantation;\n3. Evidence for cell membrane BCMA expression；\n4. All genders, ages: 18 to 75 years；\n5. The expect time of survive is above 12 weeks;\n6. KPS\\>60；\n7. No serious mental disorders ;\n8. Left ventricular ejection fraction ≥50%\n9. Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x ULN;\n10. Sufficient renal function defined by creatinine clearance≤2 x ULN;\n11. Sufficient pulmonary function defined by indoor oxygen saturation≥92%;\n12. With single or venous blood collection standards, and no other cell collection contraindications;\n13. Ability and willingness to adhere to the study visit schedule and all protocol requirements.\n\nExclusion Criteria:\n\n1. Have received CAR-T therapy or other genetically modified cell therapy before screening；\n2. Participated in other clinical research within 1 month before screening；\n3. Have received the following anti-tumor treatment before screening: Have received chemotherapy, targeted therapy or other experimental drug treatment within 4 weeks, except those who have confirmed disease progression after treatment;\n4. Live attenuated vaccine within 4 weeks before screening;\n5. Convulsion or stoke within past 6 months;\n6. Previous history of other malignancy;\n7. Presence of uncontrolled active infection;\n8. Subjects with positive HBsAg or HBcAb positive and peripheral blood HBV DNA titer is higher than the lower limit of detection of the research institution; HCV antibody positive and peripheral blood HCV RNA titer is higher than the lower limit of detection of the research institution; HIV antibody positive; syphilis primary screening antibody positive;\n9. Pregnant or breasting-feeding women;\n10. Any situation that investigators regard not suitable for attending in this study or may affect the data analysis.'}, 'identificationModule': {'nctId': 'NCT04272151', 'briefTitle': 'Safety and Efficacy of BCMA-Targeted CAR-T Therapy for Relapsed/Refractory Multiple Myeloma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chongqing Precision Biotech Co., Ltd'}, 'officialTitle': 'Safety and Efficacy of BCMA-Targeted CAR-T Therapy for Relapsed/Refractory Multiple Myeloma', 'orgStudyIdInfo': {'id': 'PBC015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BCMA CAR-T cells treat', 'description': 'Patients will be be treated with BCMA CAR-T cells', 'interventionNames': ['Biological: BCMA CAR-T cells']}], 'interventions': [{'name': 'BCMA CAR-T cells', 'type': 'BIOLOGICAL', 'description': 'A single infusion of BCMA CAR-T cells will be administered intravenously.', 'armGroupLabels': ['BCMA CAR-T cells treat']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Cheng Qian, PhD', 'role': 'CONTACT', 'email': 'cqian3184@163.com'}, {'name': 'Ying Xiang, MD', 'role': 'CONTACT', 'email': '1324339678@qq.com'}, {'name': 'Cheng Qian, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ying Xiang, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chongqing University Cancer Hospital', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Zhi Yang, PhD', 'role': 'CONTACT', 'email': 'yangzhi@precision-biotech.com', 'phone': '86-13206140093'}, {'name': 'Yingzi Zhang', 'role': 'CONTACT', 'email': 'yingzi6526@163.com', 'phone': '86-18623351275'}], 'overallOfficials': [{'name': 'Cheng Qian, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chongqing University Cancer Hospital'}, {'name': 'Ying Xiang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chongqing University Cancer Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chongqing Precision Biotech Co., Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}