[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"refractory-membranous-nephropathy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:refractory-membranous-nephropathy":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":5},"100613407","phase-1-safety-and-efficacy-of-cd19-chimeric-antigen-receptor-t-cell-car-t-in-the-treatment-of-refractory-membranous-nephropathy-100613407",false,"NCT07266181","Safety and Efficacy of CD19 Chimeric Antigen Receptor T-Cell (CAR-T) in the Treatment of Refractory Membranous Nephropathy","Safety and Efficacy of CD19 Chimeric Antigen Receptor T-Cell Immunotherapy (CAR-T) in the Treatment of Refractory Membranous Nephropathy","Inclusion Criteria:\n\n* Confirmed as primary membranous nephropathy (PMN) by renal biopsy.\n* Classified as moderate-risk or high-risk refractory membranous nephropathy (rMN).\n* Moderate-risk rMN is defined as: eGFR ≥ 90 ml\u002Fmin\u002F1.73m² AND 24-hour urinary protein \\> 3.5g\u002Fd, with a reduction of no more than 50% within 6 months of receiving renin-angiotensin system inhibitor (RASi) therapy.\n* High-risk rMN is defined as meeting one of the following:\n\n  1. eGFR \\\u003C 60 ml\u002Fmin\u002F1.73m² and\u002For persistent proteinuria \\> 8g\u002Fd for more than 6 months.\n  2. Normal eGFR with proteinuria \\> 3.5g\u002Fd and ≤50% reduction after 6 months of RASi therapy, PLUS at least one of the following: Serum albumin \\\u003C 25g\u002FL; PLA2R antibody \\> 50 RU\u002FmL; Urinary α1-microglobulin \\> 40 μg\u002Fmin; Urinary IgG \\> 1 μg\u002Fmin; Urinary β2-microglobulin \\> 250 mg\u002Fd; IgG\u002Falbumin clearance ratio \\> 0.20.\n* Diagnosis of rMN requires failure of adequate first-line immunosuppressive therapy (≥6 months of steroids+cyclophosphamide, CNI, or rituximab), defined by any of the following: persistent high-titer anti-PLA2R antibody; for antibody-negative patients, persistent nephrotic syndrome (protein \\>3.5g\u002Fd, albumin \\\u003C30g\u002FL); \\\u003C50% reduction in proteinuria.\n* Age ≥ 18 years.\n* Adequate organ function, defined as:\n\n  1. Renal: eGFR ≥ 30 ml\u002Fmin\u002F1.73m².\n  2. Hepatic: ALT and AST ≤ 2.5 x ULN; Total bilirubin ≤ 1.5 x ULN.\n  3. Cardiac: LVEF ≥ 50%; NYHA Class I or II; No significant arrhythmias requiring intervention; No major cardiovascular events within the past 6 months.\n  4. Respiratory: SpO2 \\> 92% on room air.\n* Ability to understand and willingness to sign an Informed Consent Form.\n\nExclusion Criteria:\n\n* Secondary membranous nephropathy (e.g., due to SLE, malignancy, drugs, infection).\n* Active infection requiring IV antibiotics, active tuberculosis, or positive viral serology indicating active infection, including:\n\n  1. HBV: HBsAg (+) and\u002For HBcAb (+) with detectable HBV DNA.\n  2. HCV: HCV Ab (+) with detectable HCV RNA.\n  3. HIV Ab (+).\n  4. Active EBV or CMV infection (IgM+ or DNA above normal).\n  5. Positive syphilis (Treponema pallidum) antibody (requires evaluation for active infection).\n* Severe uncontrolled comorbidities, including:\n\n  1. Uncontrolled hypertension (persistent SBP \\> 160 mmHg or DBP \\> 100 mmHg).\n  2. Uncontrolled diabetes (HbA1c \\> 8% or random glucose ≥11.1 mmol\u002FL) or diabetic nephropathy.\n  3. Symptomatic deep vein thrombosis or pulmonary embolism within the past 6 months.\n  4. Active peptic ulcer or gastrointestinal bleeding within the past 6 months.\n  5. Severe congenital or acquired immunodeficiency.\n  6. Severe CNS diseases (e.g., catastrophic APS, uncontrolled epilepsy).\n  7. End-stage organ failure not attributable to PMN.\n* History of malignancy within the past 5 years, except for adequately treated non-melanoma skin cancer, cervical carcinoma in situ, or thyroid cancer.\n* Specific treatment history or plans, including:\n\n  1. Prior receipt of any cell therapy (e.g., MSCs, HSCT).\n  2. Major surgery within 24 weeks before or planned within 24 weeks after enrollment.\n  3. Planned kidney transplantation within 3 years.\n  4. History of substance abuse.\n* Participation in another interventional clinical trial within 3 months prior to enrollment.\n* Pregnant or lactating women.\n* Inability to understand the study or provide informed consent (e.g., severe dementia, mental illness).\n* Any other condition deemed by the investigator to increase risk, interfere with assessment, or affect compliance.","ALL","18 Years",{"count":19,"type":20},5,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This study is a single-center, prospective, exploratory Phase I clinical trial initiated by the team led by Associate Professor He Lijie from the Department of Nephrology, Xijing Hospital.\n\nPrior to receiving CAR-T cell therapy, patients will undergo lymphodepletion chemotherapy with cyclophosphamide (fludarabine will be added if necessary). After prophylactic administration of antihistamines and acetaminophen, patients will be infused with CD19 CAR-T cells at a dose of 1×10⁶ cells\u002Fkg.\n\nIn the subsequent 2 weeks, patients will be hospitalized for monitoring of vital signs and adverse reactions. The planned follow-up duration of this study is 1 years.",[26],"Refractory Membranous Nephropathy","RECRUITING","2025-12-18",{"date":30,"type":31},"2025-12-24","ACTUAL",{"date":33,"type":31},"2025-12-08",{"date":35,"type":20},"2028-07-31",{"name":37,"class":38},"The First Affiliated Hospital of Air Force Medicial University","OTHER"]