eligibility_summary
Adults 18–80 with ALS per revised El Escorial, within 24 months of first symptoms, if on ALS therapy, dose stable ≥28 days. Exclude: severe systemic infection now or within 2 weeks, inability/unwillingness to consent or comply, use of investigational drugs within 30 days of screening, pregnant or breastfeeding.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial NCT06453668 tests TCD601 (siplizumab) in newly diagnosed adult ALS. Drug/intervention: TCD601 is a humanized monoclonal antibody (biologic) targeting CD2, it blocks the CD2–LFA-3 costimulatory interaction and depletes/modulates CD2+ lymphocytes, thereby inhibiting T/NK cell activation and cytokine release to reduce neuroinflammation. Cells/pathways targeted: CD2-expressing lymphocytes—primarily T cells (CD4+, CD8+, effector/memory subsets), natural killer and NKT cells, suppression of T-cell costimulation and activation pathways with downstream reduction of proinflammatory cytokines, with anticipated indirect dampening of microglial/astroglial inflammatory activity in ALS. Phase: 52-week, Phase 1, single-arm safety/PK/PD with standard of care.