eligibility_summary
Adults >=18 with biopsy-confirmed IgAN (UPCR >=0.5 g/gCr, eGFR 20-<60) or PMN at moderate/high risk refractory after >=6 mo CNI/rituximab. Require adequate organ/coagulation function, SpO2 >92%, contraception, consent. Exclude: other kidney disease, secondary PMN or >50% proteinuria fall in first 6 mo, uncontrolled HTN/DM/infections, recent IS change or major surgery, substance abuse, prior cell therapy/recent trial, transplant <=3 y/planned, active HBV/HCV/EBV/CMV or syphilis, serious CV/CNS disease or recent VTE, cancer <3 y, pregnancy/lactation.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: Early Phase 1, sequential dose-escalation of IM19 CAR-T in IgA nephropathy (IgAN) with proteinuria/renal dysfunction and medium–high risk primary membranous nephropathy (PMN). Intervention/type: IM19 chimeric antigen receptor T cell injection—autologous cellular gene therapy (CAR-T), dosed at 0.5×10^8 or 1×10^8 cells. Mechanism of action: Patient T cells are engineered with a CAR to recognize a B‑cell antigen and kill pathogenic B cells, aiming to deplete autoantibody/IgA-producing clones, suppress humoral autoimmunity, and reduce immune complex–mediated glomerular injury. Targets (cells/pathways): B cells (including autoreactive/IgA-producing B cells), humoral immune pathway, downstream effects monitored via proteinuria and eGFR (IgAN) and anti-PLA2R antibody levels and clinical response (PMN). Key outcomes: safety, response (CR/PR), biomarker changes, and CAR-T cell persistence.