Safety and Efficacy of CD19 Chimeric Antigen Receptor T-Cell (CAR-T) in the Treatment of Refractory Membranous Nephropathy

Exclusion Criteria

• •Secondary membranous nephropathy (e.g., due to SLE, malignancy, drugs, infection).
• •Active infection requiring IV antibiotics, active tuberculosis, or positive viral serology indicating active infection, including:
• •1. HBV: HBsAg (+) and/or HBcAb (+) with detectable HBV DNA.
• •2. HCV: HCV Ab (+) with detectable HCV RNA.
• •3. HIV Ab (+).
• •4. Active EBV or CMV infection (IgM+ or DNA above normal).
• •5. Positive syphilis (Treponema pallidum) antibody (requires evaluation for active infection).
• •Severe uncontrolled comorbidities, including:
• •1. Uncontrolled hypertension (persistent SBP \> 160 mmHg or DBP \> 100 mmHg).
• •2. Uncontrolled diabetes (HbA1c \> 8% or random glucose ≥11.1 mmol/L) or diabetic nephropathy.
• •3. Symptomatic deep vein thrombosis or pulmonary embolism within the past 6 months.
• •4. Active peptic ulcer or gastrointestinal bleeding within the past 6 months.
• •5. Severe congenital or acquired immunodeficiency.
• •6. Severe CNS diseases (e.g., catastrophic APS, uncontrolled epilepsy).
• •7. End-stage organ failure not attributable to PMN.
• •History of malignancy within the past 5 years, except for adequately treated non-melanoma skin cancer, cervical carcinoma in situ, or thyroid cancer.
• •Specific treatment history or plans, including:
• •1. Prior receipt of any cell therapy (e.g., MSCs, HSCT).
• •2. Major surgery within 24 weeks before or planned within 24 weeks after enrollment.
• •3. Planned kidney transplantation within 3 years.
• •4. History of substance abuse.
• •Participation in another interventional clinical trial within 3 months prior to enrollment.
• •Pregnant or lactating women.
• •Inability to understand the study or provide informed consent (e.g., severe dementia, mental illness).
• •Any other condition deemed by the investigator to increase risk, interfere with assessment, or affect compliance.