原始来源记录
决策级临床试验登记变更
Artiva与FDA就AlloNK在难治性RA中的单一3期试验达成一致
Artiva就AlloNK联合利妥昔单抗对比单用利妥昔单抗在约150例难治性RA患者中的单一3期注册性随机对照试验获得FDA一致意见。该试验将以6个月时的ACR50应答作为主要终点，计划于2026年下半年启动。此前2a期积极数据表明ACR50应答率为71%，并实现深度B细胞耗竭且门诊耐受性良好。
关键事实
来源摘录
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