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标签：#cell therapy
生物技术公司NKGen Biotech股份有限公司（NKGN）周三宣布，它收到了加拿大卫生部关于其1/2a期研究临床试验申请的无异议函，该研究旨在评估SNK01自然杀伤细胞疗法治疗中度阿尔茨海默病患者的安全性、耐受性和探索性疗效。
Biotechnology company NKGen Biotech Inc. (NKGN) announced Wednesday that it has received a No Objection Letter from Health Canada for its Clinical Trial Application for a Phase 1/2a study to evaluate the safety, tolerability, and exploratory efficacy of SNK01 natural killer cell therapy for the treatment of patients with moderate Alzheimer's Disease.
SNK01项目在2023年10月获得美国食品药品监督管理局IND批准，现在获得加拿大卫生部的CTA批准方面继续取得积极进展。美国SNK01在中度阿尔茨海默病患者中的1/2a期试验于2023年12月正式开始，第一名患者入选。
SNK01 program continues to show positive progress with the FDA IND clearance in October 2023, and now the CTA clearance by Health Canada. The U.S. Phase 1/2a trial of SNK01 in moderate Alzheimer's disease patients officially opened with first patient enrolled in December 2023.
这项针对约36名中度AD患者的获批试验预计将于2023年12月开始，第一批中期数据预计将于2024年第三季度公布。
This approved trial of approximately 36 patients with moderate AD is expected to commence in December 2023 with the first interim data expected in the third quarter of 2024.
第1阶段是一项开放标签安全性评估，以确定SNK01的最大耐受剂量和/或推荐的第2阶段剂量。
Phase 1 is an open label safety evaluation to determine the maximum tolerated dose and/or recommended Phase 2 dose of SNK01.
第2阶段是一项随机、安慰剂对照、多中心试验，评估SNK01在中度AD患者中的安全性和有效性。
Phase 2 is a randomized, placebo controlled, multicenter trial evaluating the safety and efficacy of SNK01 in moderate AD patients.
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