科濟藥業-B(02171.HK):CT041獲得同意在中國進入確證性II期臨試治療晚期胃癌╱食管胃結合部腺癌
格隆匯3月3日丨科濟藥業-B(02171.HK)發佈公吿,中國國家藥品監督管理局(NMPA)藥品審評中心(CDE)同意CT041進入確證性II期臨牀試驗,主要治療既往接受過至少二線治療失敗的Claudin18.2 (CLDN18.2)表達陽性的晚期胃癌╱食管胃結合部腺癌 (GC/GEJ)。
該試驗是一項在中國進行的隨機對照、多中心的臨牀試驗,旨在評估CT041治療晚期胃癌╱食管胃結合部腺癌的有效性和安全性,對照組為研究者選擇的標準治療。該試驗計劃招募約150名患者,以無進展生存期(PFS)為主要終點。截至該公吿之日,CT041為全球首個且唯一進入到確證性II期臨牀試驗的用於治療實體瘤的CAR-T細胞候選產品。
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