eligibility_summary
Adults ≥18, contraception and consent required. Adequate organ function: renal eGFR ≥15, CrCl/GFR ≥30, acceptable blood, liver, and coagulation labs. Refractory LN (ACR SLE, ISN/RPS III/IV±V or V, ANA/dsDNA+, SLEDAI ≥8, clinical ≥6) or refractory IgG4‑RD (ACR/EULAR, RI ≥2). Exclude pregnancy, recent cancer, recent B‑cell depleters, IS, or >10 mg steroids, live vaccine, active HBV/HCV/HIV/syphilis or serious infection, cardiac disease, drug allergy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial NCT06497361 tests PRG-2311, an autologous, gene‑modified cellular immunotherapy (CAR‑T). PRG-2311 T cells are engineered to co-target CD19 and BCMA, enabling cytolytic depletion of CD19+ B cells (naïve/memory) and BCMA+ plasmablasts/long‑lived plasma cells. Mechanism: CAR engagement activates T‑cell killing and elimination of pathogenic B‑lineage cells, aiming to reset humoral immunity, reduce autoantibody production (e.g., anti‑dsDNA, IgG4), and control B‑cell–driven inflammation in lupus nephritis and IgG4‑related disease. Targeted cells/pathways: B‑cell and plasma‑cell compartments, CD19 and BCMA axes of the humoral immune response. Early Phase 1, dose‑escalation (35, 100, 300 million CAR‑T) then expansion.