金斯瑞生物科技(01548.HK):傳奇生物在美國啟動LB1901一期臨牀試驗
格隆匯9月13日丨金斯瑞生物科技(01548.HK)公吿,公司非全資附屬公司傳奇生物科技股份有限公司於2021年9月13日宣佈在美國啟動一項關於LB1901的一期臨牀試驗,這是一種在研的靶向CD4的自體嵌合抗原受體T細胞(CAR-T)療法,用於治療成人複發性或難治性外周T細胞淋巴瘤(PTCL)或皮膚T細胞淋巴瘤(CTCL)。LB1901靶向的CD4靶點是一種在大多數TCL亞型中均勻表達的膜表面糖蛋白。該試驗美國食品藥品監督管理局(FDA)批准傳奇生物提交的研究新藥(IND)申請之後啟動。
一期試驗(LB1901-TCL-001)由德克薩斯大學MD安德森癌症中心淋巴瘤和骨髓瘤教授Swaminathan P.Iyer博士領導實施,這是一項針對復發或難治性PTCL或CTCL患者的開放、多中心、多隊列的臨牀研究(NCT04712864),患者患有經組織學證實的CD4+RRPTCL(非特異性外周T細胞淋巴瘤PTCL-NOS和血管免疫母細胞性T細胞淋巴瘤)或RRCTCL(蕈樣真菌病和Sézary綜合徵),該試驗招募已在美國開展。其主要目標是評估LB1901的安全性和耐受性,並確定最佳劑量。
T細胞淋巴瘤是一組異質性淋巴惡性腫瘤,在美國非霍奇金淋巴瘤病例中佔不到15%。PTCL包括一些不常見的亞型並且通常具有侵襲性,5年總生存率僅為39%。CTCL是一種主要發生在皮膚的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。
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