Ignite Creation Date:
2025-12-24 @ 3:21 PM
Ignite Modification Date:
2026-01-05 @ 5:35 PM
Study NCT ID:
NCT07000292
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-11
First Post:
2025-05-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MSC303 Subcutaneous Injection for the Treatment of Immunologic Glomerular Disease.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008181', 'term': 'Lupus Nephritis'}], 'ancestors': [{'id': 'D005921', 'term': 'Glomerulonephritis'}, {'id': 'D009393', 'term': 'Nephritis'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'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': 12}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-02-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-05', 'studyFirstSubmitDate': '2025-05-29', 'studyFirstSubmitQcDate': '2025-05-29', 'lastUpdatePostDateStruct': {'date': '2025-06-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase Ib: safety Phase II: Urine Protein/Creatinine Ratio (UPCR)', 'timeFrame': '12 week', 'description': 'Phase Ib: To evaluate the safety of MSC303 for injection in subjects with immune glomerular diseases.\n\nPhase II: To evaluate the change in Urine Protein/Creatinine Ratio (UPCR) from baseline at Week 12.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['MSC303', 'Immune glomerular diseases'], 'conditions': ['Lupus Nephritis (LN)', 'ANCA-Associated Glomerulonephritis']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety and efficacy of MSC303 in patients with Immune glomerular diseases.', 'detailedDescription': 'The primary endpoint of Phase Ib：Evaluate the safety of MSC303 in patients with Lupus Nephritis (LN）and ANCA-associated glomerulonephritis (ANCA-GN).\n\nThe primary endpoint of Phase II：Evaluate the change of Urine Protein/Creatinine Ratio (UPCR) in Week 12 compared with the baseline of MSC303 in patients with Lupus Nephritis(LN） and ANCA-associated glomerulonephritis (ANCA-GN).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 18 to 65 years (including boundary values), gender unspecified；\n2. Willing to participate voluntarily in this clinical study and with good compliance；\n3. Regarding the criteria for the study diseases, meet the diagnostic criteria for any of the following diseases:\n\n 1. Diagnosed with lupus nephritis(LN);\n 2. diagnosed with ANCA-associated glomerulonephritis (ANCA-GN);\n4. Sufficient organ function;\n\nExclusion Criteria:\n\n1. History of severe allergic reaction to humanized monoclonal antibodies, or known allergy to any component of MSC303；\n2. Active infection requiring antibiotic treatment；\n3. Concomitant with other serious diseases；\n4. Patients with congenital immunoglobulin deficiency；\n5. Infection with human immunodeficiency virus (Human immunodeficiency virus (HIV)), hepatitis B or hepatitis C (including HBsAg, HBcAb positive with abnormal Hepatitis B Virus DNA (HBV DNA) or Hepatitis C virus RNA (HCV RNA ));\n6. Other exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT07000292', 'acronym': 'MSC303', 'briefTitle': 'MSC303 Subcutaneous Injection for the Treatment of Immunologic Glomerular Disease.', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Changzheng Hospital'}, 'officialTitle': 'A Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Characteristics and Efficacy of Subcutaneous Injection of MSC303 for the Treatment of Immune Glomerular Diseases', 'orgStudyIdInfo': {'id': 'MSC303-CT201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MSC303', 'description': 'MSC303 is an asymmetric trivalent bispecific antibody targeting both CD20 and CD3 (with a ratio of CD20:CD3 at 2:1). By binding to the CD20 antigen on the surface of B cells with one end and the CD3 on the surface of T cells with the other, MSC303 recruits activated T cells around B cells, thereby enhancing the killing effect on B cells.', 'interventionNames': ['Drug: Injection of MSC303']}], 'interventions': [{'name': 'Injection of MSC303', 'type': 'DRUG', 'description': 'Dose Group 1: D1, D8, D15, and D36 were respectively given 1, 5, 15, and 15 mg of MSC303 for injection; The second dose group: D1, D8, D15 and D36 were respectively given for injection MSC303 1, 5, 20, 20 mg.', 'armGroupLabels': ['MSC303']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200003', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'contacts': [{'name': 'Huji Xu, Ph.D, MD', 'role': 'CONTACT', 'email': 'xuhuji@smmu.edu.cn', 'phone': '+862181885516'}], 'facility': 'Shanghai Changzheng Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Huji Xu, Ph.D, MD', 'role': 'CONTACT', 'email': 'xuhuji@smmu.edu.cn', 'phone': '+862181885516'}], 'overallOfficials': [{'name': 'Huji Xu, Ph.D, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai Changzheng Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Due to concerns regarding the security of patient personal information.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Changzheng Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Chief Physician, Head of the Department of Rheumatology and Immunology, Shanghai Changzheng Hospital.', 'investigatorFullName': 'Xu huji', 'investigatorAffiliation': 'Shanghai Changzheng Hospital'}}}}