[Translation] A study to evaluate the safety, tolerability and preliminary efficacy of targeted CD19 CD22 CART cell injection (B019 injection) in subjects with relapsed or refractory acute B-lymphoblastic leukemia.
主要目的:评价B019 注射液在受试者中的安全性和耐受性,确认B019 注射液在受试者中的最大耐受剂量( MTD)或II 期研究推荐剂量( RP2D);。
次要目的:评价B019注射液在受试者中的初步临床疗效;评价B019注射液输注后在受试者体内的药代动力学(PK)及药效学(PD)特征;评价B019注射液输注后在受试者中的免疫原性;评价B019 注射液输注在受试者中输注的可行性。
[Translation] Primary purpose: To evaluate the safety and tolerability of B019 injection in subjects, and to confirm the maximum tolerated dose (MTD) or recommended dose (RP2D) of B019 injection in subjects.
Secondary purpose: To evaluate the preliminary clinical efficacy of B019 injection in subjects; to evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of B019 injection in subjects after infusion; to evaluate the immunogenicity of B019 injection in subjects after infusion; to evaluate the feasibility of infusion of B019 injection in subjects.