eligibility_summary
Include: Severe IgE‑mediated food allergy with prior anaphylaxis, on dupilumab for AD/EoE ≥12 weeks or willing to start/continue, agree to carry epinephrine and update vaccines, BMI 18–32. Exclude: pregnant/lactating, significant comorbidities, PML/CNS disorders, recent severe GI disease, moderate/severe asthma or FEV1<80%, prior BCMA therapy, recent systemic steroids, immunotherapy, or serious infection, inability to stop antihistamines, epinephrine allergy, HIV+.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 1 dose-escalation trial in adults with severe IgE-mediated food allergy testing: 1) Linvoseltamab (REGN5458): an IV BCMA×CD3 bispecific T‑cell–engager antibody that redirects CD3+ T cells to kill BCMA-expressing antibody-secreting plasma cells, aiming to deplete IgE-producing plasma cells and lower food-specific IgE. 2) Dupilumab (REGN668/Dupixent): a SC monoclonal antibody against IL‑4Rα that blocks IL‑4/IL‑13 signaling to suppress type 2 (Th2) inflammation, reduce class switching to IgE, and help prevent formation of new IgE‑producing plasma cells. Targets: BCMA+ plasma cells/plasmablasts, CD3+ T cells (as effectors), IL‑4/IL‑13–IL‑4Rα axis and downstream Th2/JAK‑STAT6 signaling, indirect reduction of mast cell/basophil activation via lowered IgE.