eligibility_summary
Include: ≥18, renal eGFR ≥15. Labs: ALC ≥0.5, ANC ≥1.0, Plt ≥50, Hgb ≥8, CrCl/GFR ≥30, Tbili ≤1.5×ULN (Gilbert ok), AST/ALT ≤3×ULN, coag ≤1.5×ULN. Consent/contraception. Refractory LN: ACR SLE, active class III/IV±V or V ≤6 mo, ANA/dsDNA+, SLEDAI ≥8 (clinical ≥6). Refractory IgG4-RD: ACR/EULAR, active, RI ≥2. Exclude: pregnancy, recent cancer, recent B‑cell depletion/immunosuppression/>10 mg steroids, live vaccine ≤2 wks, active/viral infection, major cardiac disease, allergy, other unsafe.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06497387 tests PRG-1801, an autologous, genetically engineered BCMA-targeted CAR T-cell therapy (cellular immunotherapy) in refractory lupus nephritis and IgG4-related disease. Mechanism: patient T cells are modified to express a CAR recognizing BCMA (TNFRSF17) on plasmablasts and long‑lived plasma cells, inducing their selective depletion. Target cells/pathways: BCMA-expressing antibody-secreting cells within the B-cell/APRIL–BAFF–BCMA axis, intended to reduce pathogenic autoantibodies (e.g., anti-dsDNA, IgG4), suppress humoral immunity, and mitigate immune complex–driven tissue inflammation, particularly in the kidney. Dose levels: 35, 100, or 300×10^6 CAR-T cells.