科济药业(02171.HK) 公布，关键II期临床试验CT041-ST-01(NCT04581473)已取得阳性结果。
该试验是一项在中国进行的随机对照、多中心的临床试验，旨在评估舒瑞基奥仑赛注射液(研发代码：CT041，一种靶向Claudin18.2自体CAR-T细胞候选产品)治疗Claudin18.2表达阳性、既往接受过至少2线治疗失败的晚期胃/食管胃结合部腺癌的有效性和安全性，受试者以2:1的比例随机分配至舒瑞基奥仑赛注射液组或研究者选择治疗组(包括紫杉醇、多西他赛、伊立替康、阿帕替尼或纳武利尤单抗)。
该试验的主要终点为由独立评审委员会(IRC)评价的无进展生存期(PFS)。该试验主要终点已达成，即与研究者选择治疗组相比，舒瑞基奥仑赛注射液组中的受试者的无进展生存期具有统计学意义上的显著改善。既往试验数据表明，该产品安全性可控。(jl/w)(港股报价延迟最少十五分钟。沽空资料截至 2024-12-27 16:25。)
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