4
Clinical Trials associated with BZ-019(Shanghai Cell Therapy Group Co. Ltd.)A Phase II Clinical Study of CD19-targeted Chimeric Antigen Receptor (CAR) T Cells Injection, for Relapsed and Refractory (R/R) Large B-cell Lymphoma
This is a single arm,open-label, non-randomized phase 2 study to determine the efficacy of BZ019 in relapsed or refractory CD19+ B-cell Lymphoma subjects.
靶向CD19自体嵌合抗原受体T细胞注射液治疗复发或难治性大B细胞淋巴瘤的I期临床研究
[Translation] Phase I clinical study of CD19-targeted autologous chimeric antigen receptor T cell injection in the treatment of relapsed or refractory large B-cell lymphoma
主要目的:评价自体CAR-T细胞单次输注在成年复发或难治性大B细胞淋巴瘤患者中的安全性、耐受性,确定II期推荐剂量。
次要目的:评价CAR-T细胞在成年复发或难治性大B细胞淋巴瘤患者外周血中的药代、药效动力学特征、CAR-T细胞的存活情况以及抗肿瘤疗效。
[Translation] Primary objective: To evaluate the safety and tolerability of a single infusion of autologous CAR-T cells in adult patients with relapsed or refractory large B-cell lymphoma, and to determine the recommended dose for Phase II.
Secondary objective: To evaluate the pharmacokinetics and pharmacodynamic characteristics of CAR-T cells in the peripheral blood of adult patients with relapsed or refractory large B-cell lymphoma, the survival of CAR-T cells, and the anti-tumor efficacy.
A Phase I Clinical Study of CD19-targeted Chimeric Antigen Receptor (CAR) T Cells Injection, for Relapsed and Refractory (R/R) Large B-cell Lymphoma
This is an open-label, multicenter, dose-escalation phase 1 study to determine the Safety and Efficacy of BZ019 in relapsed or refractory CD19+ B-cell Lymphoma subjects.
100 Clinical Results associated with BZ-019(Shanghai Cell Therapy Group Co. Ltd.)
100 Translational Medicine associated with BZ-019(Shanghai Cell Therapy Group Co. Ltd.)
100 Patents (Medical) associated with BZ-019(Shanghai Cell Therapy Group Co. Ltd.)
100 Deals associated with BZ-019(Shanghai Cell Therapy Group Co. Ltd.)