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標簽:#cell therapy
生物技術公司NKGen Biotech股份有限公司(NKGN)周三宣布,它收到了加拿大衛生部關於其1/2a期研究臨床試驗申請的無異議函,該研究旨在評估SNK01自然殺傷細胞療法治療中度艾爾茨海默病患者的安全性、耐受性和探索性療效。
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計畫在2023年10月獲得美國食品藥品監督管理局IND批準,現在獲得加拿大衛生部的CTA批準方面繼續取得積極進展。美國SNK01在中度艾爾茨海默病患者中的1/2a期試驗於2023年12月正式開始,第一名患者入選。
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.
這項針對約36名中度AD患者的獲批試驗預計將於2023年12月開始,第一批中期數據預計將於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階段是一項開放標簽安全性評估,以確定SNK01的最大耐受劑量和/或推薦的第2階段劑量。
Phase 1 is an open label safety evaluation to determine the maximum tolerated dose and/or recommended Phase 2 dose of SNK01.
第2階段是一項隨機、安慰劑對照、多中心試驗,評估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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