eligibility_summary
Eligibility: Adults 18–70 with adequate organ function (labs within limits, SpO2≥92%, LVEF≥50%), negative pregnancy test and contraception. Cohorts: SLE (2019 EULAR/ACR or 2012 SLICC, ANA/anti-dsDNA/anti-Sm+, SLEDAI-2K>6, clinical≥4), diffuse cutaneous SSc ≤6y, AAV (MPA/GPA/EGPA) with MPO- or PR3-ANCA+, IIM (2017 ACR/EULAR, active by ≥2 core measures), primary SS (anti-SSA+, ESSDAI≥5). Exclude: recent severe SLE crisis, CK≥120×ULN, recent serious infection, HBV/HCV/HIV/syphilis, pregnancy, other risks.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06548607 is an Early Phase 1, single-arm study in active SLE, systemic sclerosis, ANCA‑associated vasculitis, idiopathic inflammatory myopathies, and primary Sjögren’s. Intervention: RD06‑04 (anti‑CD19 CAR‑T) or RD06‑05 (dual CD19/BCMA CAR‑T), autologous gene‑modified T‑cell therapies, infused IV after fludarabine (purine analog) and cyclophosphamide (alkylator) lymphodepletion. Mechanism: CAR‑T cells recognize and eliminate CD19+ B cells and, for RD06‑05, BCMA+ plasmablasts/plasma cells, aiming to deplete autoreactive B‑lineage compartments, suppress autoantibody production, and reset humoral immunity. Targets/pathways: B cells and plasmablasts/plasma cells, BCR/germinal center activity and autoantibody pathways (e.g., anti‑dsDNA, ANCA, anti‑SSA).