eligibility_summary
Adults (≥18) with autoimmune disease per criteria, inadequate response/relapse on SoC, on stable SoC ≥4 weeks, and adequate organ function. Excludes active infections (incl. TB) or peptic ulcer, severe hypogammaglobulinemia/IgA deficiency, active hepatitis/severe liver disease, uncontrolled allergy/asthma/eczema, severe cardiovascular disease, cancer <5 yrs, serious comorbidities, recent B-cell/biologic therapy, severe/drug allergies, prior organ/BM/HSCT.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Intervention: ABO2203, an mRNA therapeutic (injection) that encodes a bispecific T‑cell engager targeting CD19 and CD3. Mechanism of action: after in vivo translation, the expressed CD19×CD3 engager binds CD19 on B cells and CD3 on T cells, redirecting and activating T cells to kill CD19+ B cells. This promotes B‑cell depletion and reduction of autoantibody-producing cells. Drug type: mRNA-based immunotherapy producing a BiTE-like protein endogenously. Cells/pathways targeted: CD19+ B-cell compartments (naïve, memory, plasmablasts/plasma precursors), CD3/T-cell receptor signaling on T cells to form cytolytic synapses, resultant depletion of autoreactive B cells in refractory autoimmune disease. Early Phase 1, single-arm dose escalation/expansion.