君實生物-Ｂ(01877.HK)：抗腫瘤BTLA單抗的I期臨牀研究NCT04137900已完成首例患者給藥
格隆匯10月31日丨君實生物-Ｂ(01877.HK)公佈，公司自主研發的重組人源化抗BTLA單克隆抗體注射液(項目代號"TAB004/JS004")的I期臨牀研究NCT04137900已完成首例患者給藥。該研究旨在評估TAB004用於治療晚期不可切除或轉移性實體瘤患者(包含淋巴瘤)以及PD-1抗體耐藥患者的安全性、耐受性和藥代動力學。
NCT04137900是一項在美國開展的評估重組人源化抗BTLA單克隆抗體注射液用於晚期不可切除或轉移性實體瘤患者(包含淋巴瘤)以及PD-1抗體耐藥患者安全性和耐受性的一項多中心、開放標籤的I期臨牀研究，計劃入組144名受試者。TAB004/JS004是全球首個獲得臨牀試驗批准的抗腫瘤BTLA單抗，也是公司繼特瑞普利單抗後，第二個通過美國食品藥品監督管理局的IND審批的自主研發、具有完全自主知識產權的在研產品。相關研究表明，TAB004/JS004可以促進腫瘤特異性T淋巴細胞增殖並提高淋巴細胞功能，在BTLA人源化小鼠的腫瘤模型裏減輕腫瘤負荷並提高存活率，且有望與特瑞普利單抗聯合使用，進一步增強腫瘤特異性T細胞的增殖和抗腫瘤細胞因子的產生，為廣大患者提供更多聯合治療方法的選擇。TAB004/JS004申請用於晚期不可切除或轉移性實體瘤患者(包含淋巴瘤)以及PD-1抗體耐藥患者的藥物臨牀試驗已於2019年4月獲得美國食品藥品監督管理局批准。
NCT04137900研究是一項在美國開展的評估重組人源化抗BTLA單克隆抗體注射液用於晚期不可切除或轉移性實體瘤患者(包含淋巴瘤)以及PD-1抗體耐藥患者安全性和耐受性的一項多中心、開放標籤的I期臨牀研究，計劃入組144名受試者。主要研究終點為安全性以及不良反應事件，次要研究終點包括客觀緩解率、疾病控制率、療效持續時間、藥代動力學等。
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