中國生物科技服務(08037.HK):針對復發╱難治性CD20陽性B細胞非霍奇金淋巴瘤的I期臨牀完成首例受試者入組
格隆匯3月4日丨中國生物科技服務(08037.HK)公吿,公司一間間接非全資附屬公司上海隆耀自主研發的LY007細胞注射液一期臨牀於2022年3月1日正式在上海交通大學附屬瑞金醫院入組第一例受試者。該專案旨在評價LY007細胞注射液治療復發╱難治性CD20陽性B細胞非霍奇金淋巴瘤的耐受性、安全性和有效性,是一項單臂、開放標籤、多中心的I期臨牀試驗。
上海隆耀於2021年1月21日收到國家藥品監督管理局批准名稱為LY007的細胞注射液的臨牀試驗的批准通知書,並於2022年1月25日及2022年1月27日分別在瑞金醫院和江蘇省人民醫院順利召開啟動會。該專案由瑞金醫院趙維蒞副院長和江蘇省人民醫院血液科李建勇主任共同主持。
據悉,LY007細胞注射液為使用慢病毒載體進行遺傳修飾的靶向CD20的嵌合抗原受體自體T細胞(CAR-T)注射液,採用上海隆耀自主研發的獨特設計,在CAR-T的結構中引入獨立的共刺激信號受體OX40,實驗證明該結構能夠減少T細胞耗竭、增強CAR-T細胞的增殖和殺傷能力以及使其釋放更多的效應因數,從而在安全性和有效性兩個方面提高CAR-T的性能。
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