一项评价U16注射液治疗难治/复发B细胞非霍奇金淋巴瘤(r/r B-NHL)的安全性和有效性的单臂、开放性、多中心的I/II期临床研究
[Translation] A single-arm, open-label, multicenter Phase I/II clinical study to evaluate the safety and efficacy of U16 injection in the treatment of refractory/relapsed B-cell non-Hodgkin's lymphoma (r/r B-NHL)
I期主要研究目的:评价U16治疗难治复发B细胞非霍奇金淋巴瘤(Refractory and relapsed B-cell Non-Hodgkin's Lymphoma,r/r B-NHL)的安全性和耐受性,确认II期推荐剂量(RP2D)。 次要研究目的:1.初步评价U16治疗r/r B-NHL的有效性;2.评价U16治疗r/r B-NHL的药代动力学(PK)特征;3. 评价U16注射液治疗r/r B-NHL的药效学(PD)特征。 II期主要研究目的:评价U16治疗难治复发B细胞非霍奇金淋巴瘤(r/r B-NHL)的有效性。次要研究目的:1.进一步评价U16在治疗r/r B-NHL的有效性;2.评价评价U16治疗r/r B-NHL的安全性和耐受性;3.评价U16治疗r/r B-NHL的药代动力学(PK)特征;4. 评价U16治疗r/r B-NHL的药效学(PD)特征。
[Translation] The main purpose of the Phase I study is to evaluate the safety and tolerability of U16 in the treatment of refractory and relapsed B-cell Non-Hodgkin's Lymphoma (r/r B-NHL) and confirm the recommended dose (RP2D) for Phase II. Secondary study objectives: 1. Preliminary evaluation of the effectiveness of U16 in the treatment of r/r B-NHL; 2. Evaluate the pharmacokinetic (PK) characteristics of U16 in the treatment of r/r B-NHL; 3. Evaluate the pharmacodynamic (PD) characteristics of U16 injection in the treatment of r/r B-NHL. The main purpose of the Phase II study is to evaluate the effectiveness of U16 in the treatment of refractory and relapsed B-cell Non-Hodgkin's Lymphoma (r/r B-NHL). Secondary study objectives: 1. Further evaluate the effectiveness of U16 in the treatment of r/r B-NHL; 2. Evaluate the safety and tolerability of U16 in the treatment of r/r B-NHL; 3. 1. To evaluate the pharmacokinetic (PK) characteristics of U16 in the treatment of r/r B-NHL; 2. To evaluate the pharmacodynamic (PD) characteristics of U16 in the treatment of r/r B-NHL.
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