eligibility_summary
Adults 18–70, adequate organ function, negative pregnancy test, contraception to 12 mo post. Cohorts: SLE (ANA/dsDNA/Sm+, SLEDAI>6, clinical≥4), diffuse SSc ≤5 y, AAV (MPO/PR3+), IIM (≥2 core activity abn), SS (anti‑SSA+, ESSDAI≥6), MS (RMS, EDSS≤5), NMOSD (AQP4+), MG (gMG, MGFA II–IV, Ab+). Exclude: recent SLE≤8 w or MG≤2 w crisis, IIM CK≥120×ULN, infection ≤2 w, active HBV/HCV/HIV/syphilis, pregnancy/lactation, investigator risk, stable asthma/COPD allowed.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial NCT06548620: Early-phase, single-arm, open-label IIT in China testing RD06-04, an autologous CD19-directed chimeric antigen receptor (CAR) T-cell therapy, in adults with autoantibody-mediated autoimmune diseases (SLE, SSc, AAV, IIM, SS, MS, NMOSD, MG). Mechanism: patient T cells are engineered to express a CAR that binds CD19 and, upon engagement, mediate cytotoxic clearance of CD19+ B-lineage cells (naive/memory B cells and plasmablasts), reducing pathogenic autoantibody production and reshaping humoral immunity. Targets/pathways: CD19-expressing B cells and plasmablasts, B-cell receptor signaling, germinal center/Tfh interactions, and autoantibody-generation pathways. Primary aims: safety, tolerability, PK/PD, and preliminary efficacy. Sponsor: Nanjing Bioheng Biotech. Status: Not yet recruiting.