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

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.

NCT Number	NCT07266181
Lead Sponsor	The First Affiliated Hospital of Air Force Medicial University
Conditions	Refractory Membranous Nephropathy
Enrollment	5 participants
Start Date	2025-12-08
Primary Completion	2027-07-31 (estimated)
Study Completion	2028-07-31 (estimated)
Updated on ClinicalTrials.gov	2025-12-24