eligibility_summary
Adults 18-75. LN: SLE per 2019 EULAR/ACR, biopsy-proven class III/IV LN (2018 ISN/RPS), refractory to >=2 regimens. ERL: SLE per 2019 criteria with severe/relapsing disease unresponsive to >=2 recent DM therapies. AAV: GPA or MPA per 2022 ACR/EULAR. Exclude: prior CD19-directed cell therapy (e.g., CAR T/NK), CNS lupus/disorders, antiphospholipid syndrome, for AAV, exclude EGPA.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Study NCT06294236 evaluates SC291, a hypoimmune, allogeneic CD19-directed CAR T-cell therapy (biologic, cellular therapy) for severe r/r SLE (LN and ERL) and ANCA-associated vasculitis. Mechanism: engineered T cells recognize CD19 and eliminate CD19+ B-lineage cells, aiming to deplete autoreactive naïve/memory B cells and plasmablasts, reset humoral immunity, and reduce autoantibodies, “hypoimmune” design reduces host immune rejection. Pre-infusion lymphodepletion uses cyclophosphamide (alkylating cytotoxic) and fludarabine (purine analog antimetabolite) to enhance CAR T expansion/persistence. Targets/pathways: CD19 on B cells, B-cell receptor and germinal center activity, autoantibody production (e.g., anti-dsDNA, ANCA), broad lymphocyte reduction from preconditioning.