科濟藥業-B(02171.HK):舒瑞基奧侖賽注射液中國確證性II期臨牀試驗已完成入組
格隆匯8月19日丨科濟藥業-B(02171.HK)發佈公吿,舒瑞基奧侖賽注射液(研發代碼:CT041,一種靶向Claudin18.2自體CAR-T細胞候選產品)在中國進行的確證性II期臨牀試驗已按照臨牀方案完成入組和隨機。該試驗是一項在中國進行的開放標籤、多中心、隨機對照臨牀試驗,旨在評估舒瑞基奧侖賽注射液治療Claudin18.2表達陽性、既往接受過至少2種治療失敗的晚期胃癌╱食管胃結合部腺癌的患者的有效性和安全性,以由獨立評審委員會(IRC)評估的無進展生存期(PFS)為主要終點,對照組為研究者選擇治療(包括紫杉醇、多西他賽、伊立替康、阿帕替尼或納武利尤單抗)。
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