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.
Prior 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/kg.
In 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.
Confirmed as primary membranous nephropathy (PMN) by renal biopsy.
Classified as moderate-risk or high-risk refractory membranous nephropathy (rMN).
Moderate-risk rMN is defined as: eGFR ≥ 90 ml/min/1.73m² AND 24-hour urinary protein > 3.5g/d, with a reduction of no more than 50% within 6 months of receiving renin-angiotensin system inhibitor (RASi) therapy.
eGFR < 60 ml/min/1.73m² and/or persistent proteinuria > 8g/d for more than 6 months.
Secondary membranous nephropathy (e.g., due to SLE, malignancy, drugs, infection).
HBV: HBsAg (+) and/or HBcAb (+) with detectable HBV DNA.
HCV: HCV Ab (+) with detectable HCV RNA.
HIV Ab (+).