eligibility_summary
Eligibility: Adults ≥18 with SLE (2019 EULAR/ACR), biopsy-proven class III/IV lupus nephritis (2018 ISN/RPS), positive ANA/anti-dsDNA/anti‑Smith, and up-to-date vaccines incl. COVID‑19. Exclude: rapidly progressive GN, severe CNS lupus, prior CAR‑T/gene therapy or stem cell transplant, active HBV/HCV, HIV, primary immunodeficiency, splenectomy, significant neurologic or cardiac disease, prior malignancy unless treated basal/squamous cell skin cancer, cervical/breast CIS ≥3y, or other in remission ≥5y.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05938725 (KYSA-1) tests KYV-101, an autologous, fully human anti-CD19 chimeric antigen receptor T-cell (CAR-T) therapy, plus lymphodepletion (cyclophosphamide + fludarabine) in refractory lupus nephritis (Class III/IV). Mechanism: patient T cells are engineered to express a CD19-specific CAR, after lymphodepletion, CAR-T cells expand and kill CD19+ targets, depleting autoreactive B-lineage cells (naive, memory, plasmablasts) in blood, lymphoid, and tissue sites to reduce pathogenic autoantibodies and B cell-driven inflammation. Drug types: cellular therapy (CAR-T) and chemotherapy (alkylator cyclophosphamide, purine analog fludarabine). Cells/pathways targeted: CD19+ B cells, humoral autoimmunity/autoantibody production and germinal center activity.