eligibility_summary
Inclusion: ≥5 yrs, SLE per 2019 EULAR/ACR, ANA≥1:80 or anti‑dsDNA/anti‑Sm>ULN, inadequate response to ≥3 therapies (≥1 IS/biologic), SLEDAI‑2K ≥6, on stable standard therapy, labs OK (ALC, CD19+≥25/µL, ANC, Hb, Plt, LVEF≥55, eGFR≥30, AST/ALT≤3×ULN, Tbili≤2×ULN, SpO2≥92), contraception, consent. Exclude: active CNS lupus, severe nephritis/APS, major cardiac disease, key infections (TB, HBV/HCV/HIV, CMV/EBV) or low IgG, recent transplant/GVHD/MAS, recent anti‑CD19/20, JAK/BTK/TYK2, cyclophosphamide/biologics, live vaccine, pregnancy, malignancy, recent trials, depression/suicidality, other unsuitability.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT06789107 tests blinatumomab for refractory/active SLE (≥5 years). Intervention: blinatumomab 5 µg/m²/day IV (max 9 µg/day) for two 5‑day cycles. Drug type/mechanism: blinatumomab is a bispecific T‑cell engager (BiTE) antibody construct that binds CD19 on B cells and CD3 on T cells, redirecting cytotoxic T cells to kill CD19+ B cells. Expected effects: rapid depletion of pathogenic B cells/plasmablasts, reduced autoantibody production (ANA, anti‑dsDNA, anti‑Sm), and decreased immune complex/complement‑mediated inflammation. Target cells/pathways: CD19+ B cells driving humoral autoimmunity, T‑cell cytotoxic pathway (perforin/granzyme) engaged via CD3, potential cytokine release signaling. Eligibility requires peripheral CD19+ B cells ≥25/µL, confirming target presence. Aim: lower SLE disease activity by interrupting B‑cell–mediated autoimmunity.