eligibility_summary
Eligibility: 18–65, CD19+ B cells, adequate organ function, contraception/neg HCG, consent. Diseases: SLE, pSS, SSc, IIM, AAV, APS, active, refractory/relapsed ± progressive after ≥6 mo standard therapy. Exclude: uncontrolled infection, CNS/cardiac disease, ESRD, malignancy<5y, HBV/HCV/HIV/syphilis+, psychiatric, recent trials/biologics/IS/steroids, pregnancy. CAR‑T: product ready, organ OK (CrCl>30, ALT/AST≤3×ULN, TBIL≤1.5×ULN), no infection or >10 mg/d steroids in 72h.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: Autologous anti‑CD19‑CD3E CAR‑T cells (biologic, cell therapy). T cells are engineered with an FMC63 anti‑CD19 scFv, CD28 hinge/transmembrane, and intracellular CD3ε, CD28, and CD3ζ signaling domains to provide activation and costimulation upon CD19 binding. Administered as a single IV infusion after lymphodepletion with fludarabine (purine analog inhibiting DNA synthesis, lymphotoxic) and cyclophosphamide (alkylating agent). Mechanism of action: CAR engagement eliminates CD19+ B cells, aiming to ablate autoreactive B‑cell pools and reset humoral immunity across refractory autoimmune diseases. Targets: CD19‑expressing B cells (naive, memory, plasmablasts), pathways include B‑cell receptor signaling, antigen presentation, and autoantibody production (e.g., anti‑dsDNA/SSA/ANCA/aPL). Signaling domains leverage CD28 and CD3 (ε/ζ) T‑cell activation pathways.