Clinical Study of Anti-CD19/BCMA Universal Chimeric Antigen Receptor T Cells (UCAR-T) in the Treatment of Refractory Idiopathic Membranous Nephropathy (IMN)

Inclusion Criteria

• •1. Aged 18 to 75 years inclusive, either gender;
• •2. Adequate function of major organs as defined below:
• •1. Absolute neutrophil count ≥ 1.0 × 10⁹/L, hemoglobin ≥ 60 g/L, platelet count ≥ 50 × 10⁹/L;
• •2. Hepatic function: ALT ≤ 3 × ULN; AST ≤ 3 × ULN; total bilirubin (TBIL) ≤ 1.5 × ULN;
• •3. Coagulation function: international normalized ratio (INR) ≤ 1.5 × ULN, prothrombin time (PT) ≤ 1.5 × ULN;
• •4. Cardiac function: hemodynamically stable, left ventricular ejection fraction (LVEF) ≥ 50%;
• •3. Female subjects of childbearing potential and male subjects whose partners are women of childbearing potential must use a medically acceptable contraceptive method or practice abstinence during study treatment and for at least 6 months after the end of treatment.Female subjects of childbearing potential must have a negative serum HCG test within 7 days prior to enrollment and must not be breastfeeding;
• •4. Voluntarily agree to participate in this clinical study, provide written informed consent, demonstrate good compliance, and be willing to comply with follow-up procedures;
• •5. Diagnosis of primary membranous nephropathy confirmed by renal biopsy pathology;
• •6. Meet the clinical criteria for high-risk or relapsed/refractory membranous nephropathy, defined as:
• •High-risk patients meeting any of the following:
• •1. Estimated glomerular filtration rate (eGFR, CKD-EPI equation) \< 60 mL/min/1.73 m², and/or urinary protein \> 8 g/day for ≥ 6 months;
• •2. Normal eGFR, urinary protein \> 3.5 g/day despite ACEI/ARB treatment for 6 months with \< 50% reduction in proteinuria, plus serum albumin \< 25 g/L or anti-PLA2R antibody (aPLA2R) \> 50 RU/mL; Refractory membranous nephropathy: inadequate response or resistance to prior immunosuppressive therapy (including corticosteroids and/or cytotoxic agents, immunosuppressants and/or biologics), defined as persistent urinary protein ≥ 3.5 g/day with \< 50% reduction from baseline; Relapsed membranous nephropathy: recurrence (24-hour urinary protein ≥ 3.5 g) after achieving complete or partial remission (CR/PR) following treatment;
• •7. For relapsed/refractory membranous nephropathy patients during screening: eGFR ≥ 45 mL/min/1.73 m².