A Phase 2, Multicenter Study to Determine the Efficacy and Safety of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma

This is an open label, single-arm, multicenter, Phase 2 study to evaluate the efficacy and safety of bb2121 in subjects with relapsed and refractory multiple myeloma. A leukapheresis procedure will be performed to manufacture bb2121 chimeric antigen receptor (CAR) modified T cells. Prior to bb2121 infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide.

本研究为一项开放标签、单臂、多中心II期临床试验，旨在评估bb2121用于复发难治性多发性骨髓瘤受试者的有效性与安全性。研究将通过白细胞分离术制备bb2121嵌合抗原受体（chimeric antigen receptor，CAR）修饰T细胞。在输注bb2121前，受试者需接受氟达拉滨与环磷酰胺组成的淋巴细胞清除疗法。