Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:11 AM
Study NCT ID:
NCT04714827
Status:
RECRUITING
Last Update Posted:
2023-12-29
First Post:
2021-01-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Targeting CD19 and BCMA CAR-T Cells Immunotherapy in Patients With Relapsed or Refractory 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': 'D003520', 'term': 'Cyclophosphamide'}], 'ancestors': [{'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-26', 'studyFirstSubmitDate': '2021-01-07', 'studyFirstSubmitQcDate': '2021-01-15', 'lastUpdatePostDateStruct': {'date': '2023-12-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DLT', 'timeFrame': 'Form infusion CAR-T cells to 28 days after infusion', 'description': 'Observe wether dose limiting toxicity will happened in dose escalation phase'}, {'measure': 'ORR', 'timeFrame': 'Form infusion CAR-T cells to 2 years after infusion', 'description': 'The overall response rate after CAR-T Cells immunotherapy'}], 'secondaryOutcomes': [{'measure': 'Incidence of various types of adverse recation', 'timeFrame': 'Form infusion CAR-T cells to 2 years after infusion', 'description': 'According to CTCAE 5.0, record the level , type of adverse events, evaluat the correlation of CD19-BCMA CAR-T cells'}, {'measure': 'PFS', 'timeFrame': 'Form infusion CAR-T cells to 2 years after infusion', 'description': 'Progression-free surial'}, {'measure': 'DOR', 'timeFrame': 'Form infusion CAR-T cells to 2 years after infusion', 'description': 'Duration of Response'}, {'measure': 'OS', 'timeFrame': 'Form infusion CAR-T cells to subjects died，assessed up to 60 months', 'description': 'Overall survival'}, {'measure': 'Cmax', 'timeFrame': 'Before removal of lymphocytes, before CAR - T cells infusion, Day1, Day3, Day5, Day7, Day10, Day14, Day21, Day28, Month2, Month3, Month6, Month9, Month12, Month15, Month18, Month21, Month24', 'description': 'By measuring the CAR - T cells copy number and the positive rate, peak plasma concentration is determined'}, {'measure': 'Tmax', 'timeFrame': 'Before removal of lymphocytes, before CAR - T cells infusion, Day1, Day3, Day5, Day7, Day10, Day14, Day21, Day28, Month2, Month3, Month6, Month9, Month12, Month15, Month18, Month21, Month24', 'description': 'The maximum concentration of time'}, {'measure': 'AUC（0-720d）', 'timeFrame': 'Before removal of lymphocytes, before CAR - T cells infusion, Day1, Day3, Day5, Day7, Day10, Day14, Day21, Day28, Month2, Month3, Month6, Month9, Month12, Month15, Month18, Month21, Month24', 'description': 'Area under the plasma concentration versus time curve'}, {'measure': 'Concentration of IL2 level', 'timeFrame': 'Before removal of lymphocytes, before CAR - T cells infusion, Day1, Day3, Day5, Day7, Day10, Day14, Day21, Day28, Month2, Month3, Month6, Month9, Month12, Month15, Month18, Month21, Month24', 'description': 'The levels of cytokines（IL2 ）in peripheral blood and bone marrow'}, {'measure': 'Concentration of IL6 level', 'timeFrame': 'Before removal of lymphocytes, before CAR - T cells infusion, Day1, Day3, Day5, Day7, Day10, Day14, Day21, Day28, Month2, Month3, Month6, Month9, Month12, Month15, Month18, Month21, Month24', 'description': 'The levels of cytokines（ IL6 ）in peripheral blood and bone marrow'}, {'measure': 'Concentration of IL10 level', 'timeFrame': 'Before removal of lymphocytes, before CAR - T cells infusion, Day1, Day3, Day5, Day7, Day10, Day14, Day21, Day28, Month2, Month3, Month6, Month9, Month12, Month15, Month18, Month21, Month24', 'description': 'The levels of cytokines（IL10 ）in peripheral blood and bone marrow'}, {'measure': 'Concentration of TNF-α level', 'timeFrame': 'Before removal of lymphocytes, before CAR - T cells infusion, Day1, Day3, Day5, Day7, Day10, Day14, Day21, Day28, Month2, Month3, Month6, Month9, Month12, Month15, Month18, Month21, Month24', 'description': 'The levels of cytokines（TNF-α ）in peripheral blood and bone marrow'}, {'measure': 'Concentration of IFN-γ level', 'timeFrame': 'Before removal of lymphocytes, before CAR - T cells infusion, Day1, Day3, Day5, Day7, Day10, Day14, Day21, Day28, Month2, Month3, Month6, Month9, Month12, Month15, Month18, Month21, Month24', 'description': 'The levels of cytokines（IFN-γ ）in peripheral blood and bone marrow'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Myeloma']}, 'descriptionModule': {'briefSummary': 'Evaluation the safety,tolerability, preliminary efficacy,and PK/PD of KQ-2003 CAR-T cells for the treatment of multiple myeloma', 'detailedDescription': 'A non randomized study ,plans to enrollment 24 patients of B cell lymphoma ，divided into low, medium and high dose groups，to evaluate the safety and tolerability of KQ-2003 CAR-T cells immunotherapy in patients with relapsed or refractory B cell lymphoma ，to evaluate the preliminary efficacy and observe PK/PD parameters of KQ-2003 CAR-T cells immunotherapy in patients with relapsed or refractory multiple myeloma .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Agreed to participate in this study and signed informed consent, and willing to finish all the test procedure.\n2. Age ≧ 18 years of age, gender not limited;\n3. According to IMWG， diagnosis of multiple myeloma patients;\n4. ECOG physical score ≤2 points ;\n5. Relapsed multiple myeloma: disease progressed after received at least 3 lines treatment (must including the proteasome inhibitors and immune modulators); Refractory multiple myeloma: early treatment has never reached more than MR and curative effect; Or early treatment has reached more than MR and curative effect, but the subsequent treatment process or disease progress within 60 days after the last treatment ;\n6. Have a measurable lesions in screening period (conform to one of the following standards: (1) the serum M protein: IgG protein≥10g/L, or IgA M protein ≥5g/L, or IgD M protein ≥5g/L; (2) M protein urine ≥200mg/24h; (3)If M protein in serum or urine cannot be measured,under the condition of the abnormal serum free light chain ratio,serum free light chain immunoglobulin or 100 mg/L;\n7. Test results in screening period: (1) Hb≥60 g/L (7 days before the inspection without blood transfusion),PLT≥ 50 x 10 \\^ 9 / L(7 days before the inspection without blood transfusion) ,ALC≥0.3×10\\^9/L,ANC≥0.75×10\\^9/L; (2)AST≤3ULN,ALT≤3ULN,TBIL≤2ULN；Ccr≥30 mL/min/1.73 m2;Correction of serum calcium ≤3.1mmol/L（≤12.5mg/dL）; LVEF≥40%； Baseline peripheral blood oxygen saturation ≥95%;\n8. Female subjects with fertility ,pregnancy blood test results should be negative in screening period and before remove the lymphocyte ;\n9. Expected to survival more than 3 months;\n\nExclusion Criteria:\n\n1. The active hepatitis b, HBV - DNA detection lower limit of the subjects above research center; Hepatitis c virus (HCV) antibody positive and peripheral blood HCV - RNA positive subjects; Antibodies to HIV positive subjects; Early syphilis screening antibody positive;\n2. The other clinical significance of active virus, bacterial infection, or failing to control systemic fungal infection;\n3. Any instability of systemic disease, including but not limited to, unstable angina, cerebrovascular accident, or transient ischemic (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), New York heart association (NYHA) classification level III or higher congestive heart failure, drug control of serious arrhythmia, liver, kidney or metabolic diseases, as well as the standard treatment cannot control high blood pressure;\n4. In past two years, because of autoimmune diseases such as crohn's disease, rheumatoid arthritis and systemic lupus erythematosus (sle), etc.) causing end-organ damage, or need systemic application of immunosuppressive drugs;\n5. Had a history of the central nervous system diseases, such as epilepsy, serious brain damage, dementia, Parkinson's disease, psychosis,etc which influence the appraising of test,;\n6. Diagnosed with other active malignancy in past five years(the basal or scaly skin cancer, superficial bladder cancer, breast cancer in situ, which has been cured and does not require follow-up treatment are not included );\n7. Known allergic to cyclophosphamide, fluorine dara marina or CAR - T cell s including accessories, DMSO ;\n8. Patients with pregnancy or lactation, patients do not want to take effective contraceptive measures within 6months after infusion CAR-T cells;\n9. The other situations that researchers determined doesn't fit to participate in this study."}, 'identificationModule': {'nctId': 'NCT04714827', 'briefTitle': 'Targeting CD19 and BCMA CAR-T Cells Immunotherapy in Patients With Relapsed or Refractory Multiple Myeloma', 'organization': {'class': 'OTHER', 'fullName': 'Shanxi Province Cancer Hospital'}, 'officialTitle': 'A Clinical Study to Evaluate the Safety and Effectiveness of CD19-BCMA CAR-T Cells Immunotherapy in Patients With Relapsed or Refractory Multiple Myeloma', 'orgStudyIdInfo': {'id': 'CAR-T SXZL03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low Dose Group', 'description': 'KQ-2003 CAR-T cells injection, infused only once,3-6 subjects of low dose group will be intravenously infuse with 1.0×10\\^6 CAR+T cells/kg.', 'interventionNames': ['Biological: KQ-2003 CAR-T cells']}, {'type': 'EXPERIMENTAL', 'label': 'Middle Dose Group', 'description': 'KQ-2003 CAR-T cells injection, infused only once,3-6 subjects of low dose group will be intravenously infuse with 2.5×10\\^6 CAR+T cells/kg.', 'interventionNames': ['Biological: KQ-2003 CAR-T cells']}, {'type': 'EXPERIMENTAL', 'label': 'High Dose Group', 'description': 'KQ-2003 CAR-T cells injection, infused only once,3-6 subjects of low dose group will be intravenously infuse with 5.0×10\\^6 CAR+T cells/kg.', 'interventionNames': ['Biological: KQ-2003 CAR-T cells']}, {'type': 'EXPERIMENTAL', 'label': 'Amplification Dose Group', 'description': 'KQ-2003 CAR-T cells injection, infused only once.After determined maximum tolerated dose,15 subjects of amplification dose group will be intravenously infuse with 1.0-5.0×10\\^6 CAR+Tcells/kg.', 'interventionNames': ['Biological: KQ-2003 CAR-T cells']}], 'interventions': [{'name': 'KQ-2003 CAR-T cells', 'type': 'BIOLOGICAL', 'otherNames': ['Fluorine dara marina injection', 'Cyclophosphamide injection', 'CD19-BCMA CAR-T Cells'], 'description': 'A autologous doping CAR - T cells injection targets with CD19 and BCMA，fluorine dara marina injection(30 mg/m2，QD×3d) and cyclophosphamide injection (300 mg/m2，QD×3d)will be used to remove the lymphocyte before infusion KQ-2003 CAR-T cells .', 'armGroupLabels': ['Amplification Dose Group', 'High Dose Group', 'Low Dose Group', 'Middle Dose Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '030013', 'city': 'Taiyuan', 'state': 'Shanxi', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Tao Guan, PhD', 'role': 'CONTACT', 'email': '395714554@qq.com', 'phone': '+8613509717461'}], 'facility': 'Hematology Department of ShanXi Cancer Hospital', 'geoPoint': {'lat': 37.86944, 'lon': 112.56028}}], 'centralContacts': [{'name': 'Liping Su, M.D.', 'role': 'CONTACT', 'email': 'sulp2005@sohu.com', 'phone': '13835158122', 'phoneExt': '+86'}], 'overallOfficials': [{'name': 'Liping Su, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hematology Department of ShanXi Cancer Hospital'}]}, 'ipdSharingStatementModule': {'infoTypes': ['CSR'], 'timeFrame': 'Within six months after the study completed', 'ipdSharing': 'YES', 'description': 'Plan to Share Clinical Study Report within six months after the study completed', 'accessCriteria': 'Research site'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanxi Province Cancer Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Novatim Immune Therapeutics (Zhejiang) Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}