eligibility_summary
Eligibility: Adults 18–70 with active SLE (2019 EULAR/ACR or 2012 SLICC), on stable ≥2 months steroids ± immunosuppressants/biologics, ANA and/or anti-dsDNA/anti-Sm positive, SLEDAI-2K >6 (clinical ≥4), BILAG A≥1 or B≥2, PGA ≥1, adequate organ function, LVEF ≥50%, SpO2 ≥92%. Negative pregnancy test, contraception. Exclude: recent severe lupus crises, CNS/cardiac disease, transplant, recent cancer, active/recurrent infection, HBV/HCV/HIV, live vaccine, high-dose steroids, dialysis, substance abuse/suicide risk, recent trials, hypersensitivity.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial NCT06310811 tests RD06-04, an autologous anti‑CD19 CAR‑T cell therapy (gene‑modified cellular immunotherapy) in adults with moderate–severe active SLE. Mechanism: patient T cells are engineered with a chimeric antigen receptor to recognize CD19, leading to targeted cytotoxic depletion of CD19+ B lineage cells (naive, memory B cells, plasmablasts), thereby reducing autoantibody production and B cell–driven inflammation. Targeted cells/pathways: CD19+ B cells, humoral autoimmunity (autoantibody generation), B‑cell receptor signaling, germinal center activity, and antigen presentation. Design: single‑arm, Phase I, 3+3 dose escalation with two doses (1×10^5 or 5×10^5 CAR+ T cells/kg) to assess safety, PK/PD, and preliminary efficacy.