艾瑟伦医疗宣布，其血液净化器临床试验取得关键进展。独立数据安全监测委员会完成对AEMD-2022-06试验的预定安全审查后，建议无需修改方案即可推进至下一患者队列。这项聚焦实体瘤治疗的临床研究，旨在评估血液净化器在帕博利珠单抗或纳武利尤单抗治疗无效患者中的安全性、可行性及最佳剂量方案。
试验核心监测指标涵盖不良事件发生率及实验室安全参数的临床显著变化。研究成果将为后续申报监管审批的疗效研究提供关键设计依据。目前第二队列招募已在澳大利亚三大临床基地全面启动，受试者将在七天内接受两次血液净化器治疗。
整个试验计划纳入9至18名患者。随着研究推进，阶段性数据将在未来适时披露。此次安全审查的顺利通过，标志着该创新医疗器械向临床应用迈出实质性步伐。
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