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科濟藥業-B(02171.HK):CT041的研究者發起試驗的研究結果在Nature Medicine上發表
格隆匯 05-10 08:03

格隆匯5月10日丨科濟藥業-B(02171.HK)發佈公吿,公司的產品CT041的研究者發起試驗的期中分析結果在Nature Medicine上發表,該雜誌為Nature旗下國際頂級醫學學術期刊(近2年影響因子為53.44)。該結果題為“Claudin18.2靶向CAR-T細胞在消化系統腫瘤中的I期期中分析試驗結果”,來自一項在中國開展的、多中心、開放標籤的I期臨牀試驗,研究CT041治療 CLDN18.2表達陽性的晚期消化系統腫瘤患者的安全性、有效性和細胞代謝動力學。

結果顯示,在37例晚期消化系統腫瘤患者中,CT041整體耐受性良好且安全性風險可控,在輸注後的28天內未發生劑量限制性毒性,未發生≥3級細胞因子釋放綜合徵,未發生神經毒性,無治療相關死亡事件。在消化系統腫瘤患者的客觀緩解率(ORR)和疾病控制率(DCR)分別為48.6%和73.0%,在胃癌患者的ORR和 DCR分別達到57.1%和75.0%。這是該研究再次榮登國際學術舞台,此前該研究已被接受在2021年歐洲腫瘤內科學會(“ESMO”)年會以口頭報吿公佈CT041治療晚期消化系統腫瘤患者的研究結果,充分顯示了其巨大的學術價值和臨牀潛力。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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