Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2026-01-06 @ 7:49 PM
Study NCT ID:
NCT07241468
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-21
First Post:
2025-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Exploratory Clinical Study on the Safety and Efficacy of Anti-CD19/BCMA U CAR-T Cells in the Treatment of Relapsed/Refractory Immune-mediated Kidney Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-11-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-11-14', 'studyFirstSubmitQcDate': '2025-11-17', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Dose-Limiting Toxicity (DLT)', 'timeFrame': 'up to 52 weeks after infusion', 'description': 'To characterize the safety of anti-CD19/BCMA U CAR T Cells (KN3601) for Relapsed/Refractory Immune Nephropathy'}, {'measure': 'Incidence of Treatment Emergent Adverse Events (TEAEs)', 'timeFrame': 'up to 52 weeks after infusion', 'description': 'To characterize the safety of anti-CD19/BCMA U CAR T Cells (KN3601) for Relapsed/Refractory Immune Nephropathy'}], 'secondaryOutcomes': [{'measure': 'The overall response rate (ORR)', 'timeFrame': 'up to 52 weeks after infusion', 'description': 'To characterize the efficacy of anti-CD19/BCMA U CAR T Cells for Relapsed/Refractory Immune Nephropathy'}, {'measure': 'Disease control rate (DCR)', 'timeFrame': 'up to 52 weeks after infusion', 'description': 'To characterize the efficacy of anti-CD19/BCMA U CAR T Cells for Relapsed/Refractory Immune Nephropathy'}, {'measure': 'B cell depletion rate', 'timeFrame': 'up to 52 weeks after infusion', 'description': 'To characterize the efficacy of anti-CD19/BCMA U CAR T Cells for Relapsed/Refractory Immune Nephropathy'}, {'measure': 'B cell reconstitution', 'timeFrame': 'up to 52 weeks after infusion', 'description': 'To characterize the efficacy of anti-CD19/BCMA U CAR T Cells for Relapsed/Refractory Immune Nephropathy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Relapsed/Refractory Immune Nephropathy', 'Relapsed/Refractory Immune-mediated Kidney Disease']}, 'descriptionModule': {'briefSummary': 'A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19/BCMA U CAR T cell injection (KN3601) in patients with Relapsed/Refractory immune-mediated kidney disease'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age: ≥ 18 years old and ≤ 70 years old, male or female;\n2. 2 B cell CD19 positive expression in peripheral blood detected by flow cytometry;\n3. The functions of critical organs meet the following requirements:\n\n 1. Neutrophil count ≥ 1 x 10\\^9/L, Hemoglobin ≥60g/L, platelets ≥ 50×109/L,\n 2. Liver function: ALT ≤ 3 x ULN,AST≤3 x ULN, TBIL≤1.5 x ULN,\n 3. Coagulation function: International standardized ratio (INR) ≤ 1.5x ULN, prothrombin time (PT) ≤1.5 x ULN,\n 4. Cardiac function: good hemodynamic stability, left ventricular ejection fraction (LVEF) ≥55%.\n4. Female subjects of childbearing potential and male subjects whose partner is a female of childbearing potential are required to use medically approved contraception or abstain from sex for at least 6 months during and at least 6 months after the end of the study treatment period; female subjects of childbearing potential have had a negative serum HCG test within 7 days prior to study enrollment and are not lactating;\n5. Voluntarily participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up.\n\n Specific inclusion criteria:\n\n High-risk or relapsed/refractory primary membranous nephropathy\n6. Primary membranous nephropathy diagnosed pathologically by renal biopsy;\n7. Meets the clinical criteria for high-risk or recurrent/refractory membranous nephropathy, defined as:\n\n Subjects at risk who meet any of the following criteria: a) estimated glomerular filtration rate (eGFR, CKD-EPI equation) \\<60 mL/min/1.73m², and/or urine protein \\>8g/day persisting for more than 6 months;b) normal GFR, urinary protein \\>3.5 g/d, treated with ACEI/ARB for 6 months, urinary protein reduction \\<50%, and serum albumin \\<25 g/l or aPLA2R \\>50 RU/mL;\n\n Refractory membranous nephropathy subjects are defined as those who have shown poor response or resistance to previous immunosuppressive treatments (including corticosteroids and/or cytotoxic drugs, immunosuppressants and/or biologics), defined as persistent proteinuria ≥3.5g/day with a reduction of \\<50% compared to baseline;\n\n Recurrent membranous nephropathy is defined as a relapse (24-hour urinary protein ≥3.5 g) in subjects who have achieved complete or partial remission following treatment;\n8. Subjects with relapsed/refractory MN and eGFR ≥ 45 mL/min/1.73 m2 during the screening period;\n9. Primary IgA nephropathy pathologically confirmed by renal biopsy;\n10. Subjects have medical records showing they have been on stable and maximally tolerated doses of either ACEI or ARB, as per local SOC and applicable guidelines, for at least 3 months preceding screening;\n11. Subjects have been treated with hormones and/or cytotoxic drugs, immunosuppressants and/or biological agents (including but not limited to anti-CD20 monoclonal antibodies) for more than 6 months, and the 24-hour urine protein is ≥1.0 g; subjects with a rapidly progressive decline in kidney function (eGFR decreases by ≥50% within 3 months); or The subject relapsed after achieving complete remission/partial remission (CR/PR) following treatment (24-hour urine protein ≥1.0 g);\n12. Estimated glomerular filtration rate (eGFR, CKD-EPI formula) ≥30 mL/min/1.73m2 at screening;\n13. Meets the 2022 ACR/EULAR diagnostic criteria for ANCA-associated vasculitis, including microscopic polyangiitis, granulomatosis with polyangiitis, and eosinophilic granulomatosis with polyangiitis;\n14. ANCA-related antibodies positive (MPO-ANCA or PR3-ANCA positive);\n15. Kidney biopsy pathology is consistent with ANCA-associated vasculitis renal damage;\n16. Birmingham Vasculitis Activity Score (BVAS) ≥15 points (total score 63 points), indicating active vasculitis;\n17. At least two abnormalities related to the kidneys in the BVAS score;\n18. Subjects meeting the definition of relapsed/refractory: standard treatment is ineffective or disease activity recurs after remission. Definition of conventional treatment: using glucocorticoids (more than 1mg/kg/day) and cyclophosphamide, along with any one of the following immunomodulatory drugs for ≥3 months: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including rituximab, belimumab, and thalidomide;\n19. Estimated glomerular filtration rate (eGFR, CKD-EPI formula) ≥30 mL/min/1.73m2 at screening\n\nExclusion Criteria:\n\nSubjects who meet any of the following common exclusion criteria or disease-specific exclusion criteria will not be eligible for this study\n\nCommon exclusion Criteria:\n\n1. Subjects known to have allergic reactions, hypersensitivity, intolerance, or contraindications to CD19/BCMA universal CAR-T or any drug components that may be used in the study (including fludarabine, cyclophosphamide, and tocilizumab), or who have previously experienced severe allergic reactions;\n2. The subject has or is suspected of having uncontrolled or treatable fungal, bacterial, viral, or other infections;\n3. Subjects with central nervous system disorders caused by autoimmune diseases or non-autoimmune diseases (including epilepsy, psychiatric disorders, organic brain syndrome, cerebrovascular accidents, encephalitis, central nervous system vasculitis);\n4. Subjects with more serious heart conditions, such as angina, myocardial infarction, heart failure, and arrhythmias;\n5. Subjects with congenital immunoglobulin deficiency;\n6. The subject has other malignant tumours (excluding non-melanoma skin cancer and carcinoma in situ of the cervix, bladder cancer, and breast cancer with disease-free survival of over 5 years);\n7. Subjects with end-stage renal failure;\n8. Subjects who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and have peripheral blood HBV DNA titres above the detection limit; subjects who are positive for hepatitis C virus (HCV) antibodies and peripheral blood HCV RNA; subjects who are positive for human immunodeficiency virus (HIV) antibodies; subjects who test positive for syphilis;\n9. Subjects have mental illness and severe cognitive impairment;\n10. Subjects who have participated in other clinical trials within 6 months prior to enrolment;\n11. Female participants who are pregnant or planning to conceive;\n12. Subjects with hypertension and diabetes uncontrolled by medication;\n13. Researchers believe that there are other reasons why some subjects cannot be included in this study;\n\n Specific exclusion Criteria:\n\n Relapsed/Refractory Primary Membranous Nephropathy\n14. Secondary membranous nephropathy (e.g., hepatitis B, systemic lupus erythematosus, drug-associated, malignancy-associated, etc.), or in combination with other renal diseases confirmed by renal biopsy;\n\n Relapsed/Refractory IgA Nephropathy\n15. Exclude secondary IgA nephropathy, including but not limited to: anaphylactic purpura, ankylosing spondylitis, systemic lupus erythematosus, desiccation syndrome, viral hepatitis, cirrhosis of the liver, rheumatoid arthritis, and mixed connective tissue disease; or in combination with other renal diseases confirmed by renal biopsy;\n16. Crescentic nephritis (pathologic diagnosis of \\>50% crescentic bodies), micrognathic nephropathy with IgA deposition, and other specific types of pathologic or clinical renal disease;\n\n Relapsed/refractory ANCA-associated vasculitis kidney damage\n17. Estimated glomerular filtration rate (eGFR) \\<15 mL/min/1.73 m2;\n18. If subjects have alveolar haemorrhage and requires invasive lung ventilation, the expected duration exceeds the screening time.'}, 'identificationModule': {'nctId': 'NCT07241468', 'briefTitle': 'An Exploratory Clinical Study on the Safety and Efficacy of Anti-CD19/BCMA U CAR-T Cells in the Treatment of Relapsed/Refractory Immune-mediated Kidney Disease', 'organization': {'class': 'OTHER', 'fullName': 'Changhai Hospital'}, 'officialTitle': 'An Exploratory Clinical Study on the Safety and Efficacy of Anti-CD19/BCMA Universal Chimeric Antigen Receptor T Cells in the Treatment of Relapsed/Refractory Immune-mediated Kidney Disease', 'orgStudyIdInfo': {'id': 'CHEC2025-362'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'anti-CD19/BCMA U CAR T cells', 'interventionNames': ['Biological: anti-CD19/BCMA U CAR T']}], 'interventions': [{'name': 'anti-CD19/BCMA U CAR T', 'type': 'BIOLOGICAL', 'description': 'To evaluate the safety and effectiveness of anti-CD19/BCMA CAR T cells (KN3601) in patients with immune nephropathy. All subjects will receive fludarabine/cyclophosphamide lymphodepletion followed by anti-CD19/BCMA U CAR T cells infusion.', 'armGroupLabels': ['anti-CD19/BCMA U CAR T cells']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'country': 'China', 'contacts': [{'name': 'Zhiyong Guo, Dr', 'role': 'CONTACT', 'email': 'chguozhiyong@126.com', 'phone': '86-021-31161406'}], 'facility': 'Changhai Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Zhiyong Guo, Dr', 'role': 'CONTACT', 'email': 'chguozhiyong@126.com', 'phone': '86-021-31161406'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changhai Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rui Therapeutics Co., Ltd', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}