eligibility_summary
Adults 18–70. Eligible: refractory AAV (GPA/MPA, ANCA+, BVAS≥3, no remission ≥3 mo or relapse) or refractory active LN (SLE, renal biopsy class III/IV±V, SLEDAI≥8, ANA/dsDNA+). Labs: ALC≥0.5, ANC≥1.0, Plt≥50, Hgb≥8, CrCl/GFR≥30 (renal eGFR≥15), bili≤1.5×ULN (Gilbert ok), AST/ALT≤3×ULN, PT/INR/APTT≤1.5×ULN. Exclude: pregnancy/lactation, major CV disease, other autoimmune or severe extra‑renal SLE, recent biologics/IS or steroids>10 mg/d, live vaccines, active HBV/HCV/HIV/syphilis or serious infection, recent surgery/other trial, allergy to study drugs.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: PRG-1801, an autologous BCMA-targeted chimeric antigen receptor T-cell (CAR-T) therapy. Mechanism: Patient T cells are gene-modified to express a CAR that binds B-cell maturation antigen (BCMA/TNFRSF17), upon engagement they kill BCMA+ cells, depleting plasmablasts/plasma cells and some memory B cells, thereby reducing pathogenic autoantibody production (ANCA, anti-dsDNA) and downstream immune complex/complement–mediated inflammation. Targets: BCMA-expressing antibody-secreting cells and memory B cells, the BAFF/APRIL–BCMA survival pathway sustaining long-lived plasma cells. Design: single-arm, lymphodepletion followed by PRG-1801 at 2.5×10^6 or 5.0×10^6 CAR-T/kg in adults with refractory ANCA-associated vasculitis or proliferative lupus nephritis. Status: Recruiting in China (Tongji Hospital).