金斯瑞生物科技(01548.HK):FDA已批准傳奇生物LB1901新藥臨牀試驗申請
格隆匯12月14日丨金斯瑞生物科技(01548.HK)發佈公告,公司非全資附屬公司傳奇生物科技股份有限公司於2020年12月14日宣佈美國食品和藥物管理局(FDA)已批准其評估LB1901的新藥臨牀試驗申請,LB1901是傳奇生物在研的自體嵌合抗原受體T細胞(CAR-T)療法,用於治療成人復發或難治性T細胞淋巴瘤(TCL)。根據該新藥臨牀試驗申請,傳奇生物將在美國啟動LB1901的1期臨牀研究。
LB1901是一種靶向CD4的試驗性CAR-T產品,CD4是一種在大部分TCL亞型中均勻表達的膜表面糖蛋白。一項1期、首次人體研究、開放標籤、多中心、多隊列的臨牀研究將在美國招募復發或難治性外周T細胞淋巴瘤(PTCL)或皮膚T細胞淋巴瘤(CTCL)患者。研究的主要目標是評估LB1901的安全性和耐受性,並確定2期臨牀研究推薦劑量。
TCL是一組異質性疾病,在美國非霍奇金淋巴瘤病例中佔不到15%。外周T細胞淋巴瘤包括一些不常見的亞型並且通常具有侵襲性,5年總生存率為39%,根據亞型不同而異;皮膚T細胞淋巴瘤是一組主要發生在皮膚的T細胞惡性腫瘤。在目前的治療方案下,仍有相當比例的PTCL或CTCL患者會復發。復發或難治性PTCL和CTCL患者仍然存在高度未滿足的醫療需求。
FDA批准傳奇生物的LB1901的IND申請,是傳奇生物在細胞治療創新方面的科學專業能力的里程碑體現。傳奇生物期待與研究人員合作,探索其在滿足TCL人羣未滿足的醫療需求方面的潛力。
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