eligibility_summary
Adults ≥18 with SLE, IIM, SSc, RA, ITP, or AIHA per guideline criteria, active disease with relevant autoantibodies, prior inadequate response, stable background therapy. Labs: disease‑specific CBC minima, ALT/AST<3×ULN, adequate renal function, LVEF≥50%. Contraception required. Exclude severe organ/CNS disease, IIM/SSc complications, transplants, active infection (incl. viral serology+) or TB, recent biologics/CAR‑T/live vaccine/surgery, recent cancer, pregnancy, drug abuse, and ITP/AIHA coagulation/thrombosis risks.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: CC312, a biological trispecific T‑cell engager (TriTE) administered IV. Mechanism: CC312 simultaneously binds CD19 on B cells, CD3 on T cells, and CD28 as a co‑stimulatory signal. This bridges T cells to B cells, delivers TCR (CD3) activation plus CD28 co‑stimulation, and drives targeted cytotoxicity and depletion of CD19+ B cells/plasmablasts, aiming to reduce autoantibody production and reset dysregulated immunity. Safety note: higher CRS risk managed with a low priming dose before therapeutic dosing. Targets (cells/pathways): CD19+ B cells, T cells via CD3 and CD28, TCR signaling and co‑stimulation pathways leading to immune synapse formation, cytokine release, and B‑cell depletion.