[Translation] An open, single-arm, multicenter study of Regimen Injection (CD19-targeted chimeric antigen receptor T cells) in the treatment of relapsed and refractory large B-cell lymphoma
主要目的:
评价瑞基奥仑赛注射液 (100×106 CAR+ T细胞)治疗复发难治性(R/R)大B细胞淋巴瘤成年受试者的有效性
次要目的:
评估瑞基奥仑赛注射液的安全性
评估瑞基奥仑赛注射液有效性的深度和持久性
描述瑞基奥仑赛注射液的药代动力学(PK)和药效学(PD)特征
评估接受瑞基奥仑赛注射液治疗的受试者的无进展生存时间(PFS)和总生存时间(OS)
评估对瑞基奥仑赛注射液的免疫应答
[Translation] Primary objective:
To evaluate the efficacy of Requiorenza injection (100×106 CAR+ T cells) in the treatment of adult subjects with relapsed or refractory (R/R) large B-cell lymphoma
Secondary objectives:
To evaluate the safety of Requiorenza injection
To evaluate the depth and durability of the efficacy of Requiorenza injection
To describe the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of Requiorenza injection
To evaluate the progression-free survival (PFS) and overall survival (OS) of subjects treated with Requiorenza injection
To evaluate the immune response to Requiorenza injection