金斯瑞生物科技(01548.HK)：評估JNJ-4528初始結果將於ASH會議進行口頭報告
格隆匯12月8日丨金斯瑞生物科技(01548.HK)發佈公告，評估JNJ-68284528(JNJ-4528)有效性及安全性的Ib/II期CARTITUDE-1研究的初始結果將於2019年12月9日於美國佛羅里達州奧蘭多舉行的美國血液學會(ASH)2019年年會上的口頭彙報中進行了報告，並已在官方ASH新聞節目(577號摘要)中進行了強調。
JNJ-4528為一種正在進行評價的治療復發或難治性多發性骨髓瘤患者的研究性靶向B細胞成熟抗原(BCMA)的嵌合抗原受體T細胞(CAR-T)療法。JNJ-4528是一種結構新穎的CAR-T細胞療法，含有4-1BB共刺激結構域和兩個靶向BCMA的單域抗體，旨在使抗體具有親和力。本研究入組了既往接受過至少三線治療或對蛋白酶體抑制劑(PI)和免疫調節劑(IMiD)雙重耐藥的患者；接受過PI、IMiD和抗CD38抗體的患者；並且在開始接受最近一次治療的12個月內有疾病進展記錄的患者。
此外，在ASH會議上的口頭報告中，還將報告在CARTITUDE-1研究中入組的患者的骨髓和血液中輸注後CAR+T細胞擴增的數據(928號摘要)。雖然CD4+和 CD8+CAR+T細胞在體內均擴增，但在擴增峯值處觀察到記憶性CD8+CAR+T細胞優先擴增。上述和其他相關研究正在進行，以更好地理解與JNJ-4528應答相關的免疫機制，並表明在相對較低的T細胞劑量下觀察到的JNJ-4528的高抗骨髓瘤活性可能與其CD8+CAR+T細胞在體內優先擴增有關。
根據美國CARTITUDE-1研究結果顯示，公司觀察到其初始安全性和有效性資料與中國LEGEND-2研究一致。目前Legend Biotech正與Janssen合作，致力於推進LCAR-B38M/JNJ-4528用於RRMM患者的臨牀研發項目。
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