eligibility_summary
Eligible: 18–70 yrs, ≥40 kg, SLE per ACR‑1997 ≥24 wks, active SLE (SELENA‑SLEDAI ≥6, PGA ≥1), ≥8 wks standard therapy, negative pregnancy test + contraception. Exclude: allergy to study drugs, suicidality, CNS disease or lupus crises, systemic autoimmune/inflammatory disease, prior transplants, TB (unless treated), organ dysfunction or unstable infection, prior JAK/BTK inhibitors, B‑cell therapy, biologics, or CAR‑T, Recent: severe nephritis, PLEX/HD/IVIG, live vaccine, high‑dose steroids, major surgery, major bleed/anticoagulation, severe mental illness, substance abuse, pregnancy/lactation or planned conception ≤2 yrs, malignancy, undue risk.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial: NCT06106893 (Phase 1/2, single-arm, recruiting, China). Intervention: CD19 Universal CAR-γδ T Cells—an allogeneic, genetically engineered adoptive cellular immunotherapy (biologic). Mechanism: γδ T cells are transduced with an anti-CD19 chimeric antigen receptor, upon binding CD19, they mediate MHC-independent cytotoxicity to deplete CD19+ B cells (naïve, memory, plasmablasts), aiming to reset the B-cell compartment, reduce autoantibody production, and dampen inflammatory cascades in SLE. Targets: CD19-expressing B cells, downstream impact on B-cell receptor/autoantibody pathways and germinal center activity. Potential advantages: off-the-shelf use and lower GVHD risk inherent to γδ T cells.