[Translation] An open-label, single-arm, multicenter study of Ruiqiorenza injection (CD19 targeting 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] main purpose:
To evaluate the efficacy of Ruikiolenza injection (100×106 CAR+ T cells) in the treatment of adult subjects with relapsed and refractory (R/R) large B-cell lymphoma
Secondary purpose:
Assessing the safety of Ruikiorenza injection
Assessing the depth and persistence of the effectiveness of Reiki Olenza Injection
To characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of Rekiorenza injection
Assessing progression-free survival (PFS) and overall survival (OS) in subjects treated with Rekiorenza injection
Assessing the Immune Response to Reiki Olenza Injection