Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT04295018
Status:
UNKNOWN
Last Update Posted:
2020-03-04
First Post:
2020-03-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of BCMA-directed CAR-T Cells Treatment in Subjects With r/r 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': ['PHASE1'], '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': '2019-10-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-02', 'studyFirstSubmitDate': '2020-03-02', 'studyFirstSubmitQcDate': '2020-03-02', 'lastUpdatePostDateStruct': {'date': '2020-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Incidence of adverse events (TEAEs) within 30 days after intravenous infusion of C-CAR088', 'timeFrame': '30 days'}], 'secondaryOutcomes': [{'measure': 'Overall response rate (ORR)', 'timeFrame': '12 months', 'description': 'ORR(including sCR / CR / VGPR / PR, based on IMWG 2016 efficacy evaluation criteria)'}, {'measure': 'Progression free survival (PFS)', 'timeFrame': '6 months#12 months', 'description': 'PFS(based on IMWG 2016 efficacy evaluation criteria)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multiple Myeloma'], 'conditions': ['Multiple Myeloma']}, 'referencesModule': {'references': [{'pmid': '36100310', 'type': 'DERIVED', 'citation': 'Qu X, An G, Sui W, Wang T, Zhang X, Yang J, Zhang Y, Zhang L, Zhu D, Huang J, Zhu S, Yao X, Li J, Zheng C, Zhu K, Wei Y, Lv X, Lan L, Yao Y, Zhou D, Lu P, Qiu L, Li J. Phase 1 study of C-CAR088, a novel humanized anti-BCMA CAR T-cell therapy in relapsed/refractory multiple myeloma. J Immunother Cancer. 2022 Sep;10(9):e005145. doi: 10.1136/jitc-2022-005145.'}]}, 'descriptionModule': {'briefSummary': 'This is a single-center, non-randomized study to evaluate the safety and efficacy of C-CAR088 in relapsed or refractory multiple myeloma patients.', 'detailedDescription': 'The study will include the following sequential phases: Screening, Apheresis, Baseline, Pre-Treatment (Cell Product Preparation, Lymphodepleting Chemotherapy), C-CAR088 infusion and Follow-up Visit.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18-75 years old, male or female;\n2. The patient volunteered to participate in the study, and he or his legal guardian signed the Informed Consent;\n3. Patients with a clear diagnosis of relapsed or refractory multiple myeloma\n4. The patient have one or more measurable multiple myeloma lesion, must include one of the following conditions:\n\n * Serum M protein≥1.0 g/dL(10g/L)\n * Urine M protein≥200 mg/24h\n * Serum free light chain(sFLC): κ/λ FLC ratio is abnormal and affected FLC ≥10mg / dL\n5. Bone marrow sample is confirmed as BCMA-positive by flow cytometry or pathological examination;\n6. At least 2 weeks from monoclonal antibody therapy prior to CAR T cell therapy.\n7. ECOG scores 0 - 1;\n8. Good cardiac and pulmonary organ function;\n9. Expected survival time \\> 12 weeks;.\n10. Female subjects of childbearing age must have a negative urine / blood pregnancy test within 7 days before cell therapy and not be in lactation; female or male subjects of childbearing age need to take effective contraception throughout the study.\n\nExclusion Criteria:\n\n1. Have a history of allergy to cellular products;\n2. Laboratory testing occurs when: including but not limited to, serum total bilirubin ≥1.5mg / dl; serum ALT or AST is 2.5 times higher than the upper limit of normal value; serum creatinine ≥2.0mg / dl; hemoglobin \\<80g / L; absolute neutrophil count \\<1000 / mm3 or dependent on GCSF or Other growth factors can maintain the centriole count ≥1000 / mm²; platelet count \\<50000 / mm³ or the above level can be maintained due to platelet transfusion;\n3. Presence of clinically significant cardiovascular disease, such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or any heart function Grade 3 (moderate) or Grade 4 (severe) heart disease (according to the New York Heart Association Function Classification method: NYHA); patients with a history of myocardial infarction, cardiac angioplasty or stent implantation, unstable angina pectoris or other clinically significant heart disease within 12 months before enrollment;\n4. A history of craniocerebral trauma, consciousness disorder, epilepsy, severe cerebral ischemia or hemorrhagic disease;\n5. Need to use any anticoagulant (except aspirin);\n6. Patients requiring urgent treatment due to tumor progression or spinal cord compression;\n7. Patients with CNS metastasis or symptoms of CNS involvement;\n8. After allogeneic hematopoietic stem cell transplantation;\n9. Plasma cell leukemia;\n10. Patients with autoimmune diseases, immunodeficiency, or other immunosuppressive agents;\n11. Uncontrolled active infection;\n12. Have used any CAR T cell products or other genetically modified T cell therapy before;\n13. Hepatitis B or hepatitis C virus infection (including carriers), syphilis, as well as acquired, congenital immune deficiency diseases, including but not limited to HIV infected persons;\n14. Have a history of alcoholism, drug addiction and mental illness;\n15. Participated in any other clinical trial within 1 months;\n16. The investigators believe that there are other circumstances that are not suitable for the trial.'}, 'identificationModule': {'nctId': 'NCT04295018', 'briefTitle': 'A Study of BCMA-directed CAR-T Cells Treatment in Subjects With r/r Multiple Myeloma', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'A Phase # Study Evaluating Safety and Efficacy of C-CAR088 Treatment in Subjects With Relapsed or Refractory Multiple Myeloma', 'orgStudyIdInfo': {'id': '0203-007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'C-CAR088', 'description': 'Lymphocytes will be transduced with lentiviral vector containing CAR-BCMA gene', 'interventionNames': ['Drug: C-CAR088']}], 'interventions': [{'name': 'C-CAR088', 'type': 'DRUG', 'description': 'Autologous BCMA-directed CAR-T cells, single infusion intravenously at a target dose of 1.0-9.0 x 10\\^6 anti-BCMA CAR+T cells/kg. Other Name: CBM.BCMA Chimeric Antigen Receptor T cell.', 'armGroupLabels': ['C-CAR088']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100010', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Daobin Zhou, PhD&MD', 'role': 'CONTACT', 'email': 'zhoudb@pumch.cn', 'phone': '010-69155020'}, {'name': 'Lu Zhang', 'role': 'CONTACT', 'email': 'pumczhanglu@163.com', 'phone': '010-69155660'}], 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Daobin Zhou, PhD&MD', 'role': 'CONTACT', 'email': 'zhoudb@pumch.cn', 'phone': '010-69155020'}, {'name': 'Lu Zhang', 'role': 'CONTACT', 'email': 'pumczhanglu@163.com', 'phone': '010-69155660'}], 'overallOfficials': [{'name': 'Daobin Zhou', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking Union Medical College Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Shanghai AbelZeta Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}