Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:50 PM
Study NCT ID:
NCT03767751
Status:
UNKNOWN
Last Update Posted:
2018-12-07
First Post:
2018-12-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Feasibility and Safety Study of Dual Specificity CD38 and BCMA CAR-T Cell Immunotherapy for 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2022-12-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-12-05', 'studyFirstSubmitDate': '2018-12-05', 'studyFirstSubmitQcDate': '2018-12-05', 'lastUpdatePostDateStruct': {'date': '2018-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants with Severe/Adverse Events as a Measure of Safety and Tolerability', 'timeFrame': '24weeks'}, {'measure': 'MTD of dual specificity CD38 and BCMA CAR-T cells', 'timeFrame': '4 weeks', 'description': "The highest dose of dual specificity CD38 and BCMA CAR-T cells that is estimated to result in defined Dose Limiting Toxicity (DLT) with the exception of allowable 'expected' AEs associated with the intravenous infusion of dual specificity CD38 and BCMA CAR-T cells"}, {'measure': 'Copies numbers of CAR in peripheral blood(PB), bone marrow(BM)and lymph nodes', 'timeFrame': '24 weeks'}], 'secondaryOutcomes': [{'measure': 'Six-month Objective response rate of complete remission and partial remission', 'timeFrame': '24 weeks'}, {'measure': 'Six-month Overall survival', 'timeFrame': '24 weeks'}, {'measure': 'Six-month Progression free survival', 'timeFrame': '24 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Myeloma']}, 'descriptionModule': {'briefSummary': 'CAR-T cell therapy has shown promising results for the treatment of relapsed or refractory Multiple Myeloma,however, a subset of patients relapse due to the loss of target in tumor cells.Dual Specificity CD38 and BCMA CAR-T cells can recognize and kill the malignant cells through recognition of CD38 or BCMA. This is a phase 1/2 study designed to determine the safety of dual specificity CD38 and BCMA CAR-T cells and the feasibility of making enough to treat patients with relapsed or refractory Multiple Myeloma.', 'detailedDescription': '1. PRIMARY OBJECTIVES:\n\n 1. To evaluate the feasibility and safety of dual specificity CD38 and BCMA CAR-T cells in patients with relapsed or refractory Multiple Myeloma.\n 2. To evaluate the duration of in vivo persistence of adoptively transferred T cells, and the phenotype of persisting T cells.Real Time polymerase chain receptor (RT-PCR) and Flow cytometry(FCM) analysis of PB,BM and lymph node will be used to detect and quantify survival of universal dual specificity CD38 and BCMA CAR-T cells over time.\n2. SECONDARY OBJECTIVES:\n\n1.For patients with detectable disease, measure anti-tumor response due to dual specificity CD38 and BCMA CAR-T cell infusions.\n\n2.The CAR-T cells will be administered by i.v. injection over 20-30 minutes as a using Day 0: 1-5x10e6/kg total dose on day 0.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or female participant\n2. 12 Years to 70 Years (Child, Adult, Senior)\n3. Patient with relapsed or refractory Multiple Myeloma,multiple myeloma cell express CD38(over 50%) and BCMA (over 50%)\n4. Estimated life expectancy ≥ 12 weeks (according to investigator's judgement)\n5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1\n6. Adequate organ function\n\nExclusion Criteria:\n\n1. Prior malignancy, except carcinoma in situ of the skin or cervix treated with curative intent and with no evidence of active disease\n2. Diagnosis of Burkitt's leukemia/lymphoma according to WHO classification or chronic myelogenous leukemia lymphoid blast crisis\n3. Richter's syndrome\n4. Presence of Grade II-IV (Glucksberg) or B-D (IBMTR) acute or extensive chronic GVHD at the time of screening\n5. Subjects with any autoimmune disease or any immune deficiency disease or other disease in need of immunosuppressive therapy\n6. Severe active infection (uncomplicated urinary tract infections, bacterial pharyngitis is allowed), Prophylactic antibiotic, antiviral and antifungal treatment is permissible\n7. Active hepatitis B, active hepatitis C, or any human immunodeficiency virus (HIV) infection at the time of screening\n8. Patient has an investigational medicinal product within the last 30 days prior to screening\n9. Previous treatment with investigational gene or cell therapy medicine products\n10. Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary\n11. Pregnant or nursing women"}, 'identificationModule': {'nctId': 'NCT03767751', 'briefTitle': 'A Feasibility and Safety Study of Dual Specificity CD38 and BCMA CAR-T Cell Immunotherapy for Relapsed or Refractory Multiple Myeloma', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'Phase I/II Study to Evaluate Treatment of Relapsed or Refractory Multiple Myeloma With Dual CAR-T Cells Targeting CD38 and BCMA', 'orgStudyIdInfo': {'id': 'CHN-PLAGH-BT-037'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Dual Specificity CD38 and bcma CAR-T Cells', 'type': 'BIOLOGICAL', 'description': '1\\) Biological: Dual Specificity CD38 and BCMA CAR-T Cells,2)1-5X10E6/Kg'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100853', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weidong Han', 'role': 'CONTACT', 'email': 'hanwdrsw@sina.com', 'phone': '86-10-13651392893'}], 'facility': 'Biotherapeutic Department and Hematology Department of Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'YaJing Zhang', 'role': 'CONTACT', 'email': 'plagh@qq.com', 'phone': '86-10-55499341'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Molecular & Immunological Department,Biotherapeutic Department', 'investigatorFullName': 'Han weidong', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}