原始出處紀錄
決策級臨床試驗登錄異動
Artiva 與 FDA 達成單一 Phase 3 試驗共識，AlloNK 用於難治性 RA
Artiva 獲得 FDA 核准，針對約 150 名難治性 RA 患者進行單一 Phase 3 註冊性隨機對照試驗，比較 AlloNK 合併 rituximab 與單獨使用 rituximab 的療效。試驗將以六個月時的 ACR50 反應率作為主要終點，預計於 2026 年下半年啟動。此前 Phase 2a 數據顯示 71% ACR50 反應率及深度 B 細胞耗竭，且門診耐受性良好。
關鍵事實
來源摘錄
EX-99.1 2 d38160dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Artiva Biotherapeutics Reports First Quarter 2026 Financial Results and Recent Business Highlights Initial AlloNK ® (AB-101) clinical data demonstrated 71% ACR50 response in refractory rheumatoid arthritis (RA) patients with at least six months of follow-up in the company-sponsored Phase 2a basket trial, with no patients relapsing or requiring new immunomodulatory agents AlloNK treatment regimen demonstrated a consistent pattern of deep B-cell depletion and tolerability results supportive of outpatient administration in community rheumatology settings U.S. Food and Drug Administration (FDA) alignment on a single Phase 3 registrational randomized controlled trial evaluating AlloNK plus rituximab versus rituximab alone in approxima