[Translation] A multicenter, open-label, phase Ib/II clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and preliminary anti-tumor efficacy of YK012 in the treatment of B-cell acute lymphoblastic leukemia
Ib期剂量递增研究:(1)主要目的:评价YK012在B细胞急性淋巴细胞白血病患者中的安全性和耐受性。(2)次要目的:评价YK012在B细胞急性淋巴细胞白血病患者中的药代动力学(PK)特征;评价YK012在B细胞急性淋巴细胞白血病患者中的免疫原性;初步探索YK012在B细胞急性淋巴细胞白血病中的血液学缓解(完全缓解/完全缓解伴部分血液学恢复[CR/CRi])率。(3)探索性目的:探索YK012的药效动力学(PD)特征。
Ⅱ期剂量扩展研究:(1)主要目的:进一步评价YK012在选定剂量下治疗B细胞急性淋巴细胞白血病成人患者中的安全性、耐受性和初步抗肿瘤疗效。(2)次要目的:进一步评价YK012在选定剂量下治疗B细胞急性淋巴细胞白血病患者中的PK特征;进一步评价YK012在B细胞急性淋巴细胞白血病患者中的免疫原性。(3)探索性目的:探索YK012的PD特征。
[Translation] Phase Ib dose escalation study: (1) Primary objective: To evaluate the safety and tolerability of YK012 in patients with B-cell acute lymphoblastic leukemia. (2) Secondary objectives: To evaluate the pharmacokinetic (PK) characteristics of YK012 in patients with B-cell acute lymphoblastic leukemia; To evaluate the immunogenicity of YK012 in patients with B-cell acute lymphoblastic leukemia; To preliminarily explore the hematological remission (complete remission/complete remission with partial hematological recovery [CR/CRi]) rate of YK012 in B-cell acute lymphoblastic leukemia. (3) Exploratory objective: To explore the pharmacodynamic (PD) characteristics of YK012.
Phase II dose expansion study: (1) Primary objective: To further evaluate the safety, tolerability and preliminary anti-tumor efficacy of YK012 in the treatment of adult patients with B-cell acute lymphoblastic leukemia at selected doses. (2) Secondary objectives: To further evaluate the PK characteristics of YK012 in patients with B-cell acute lymphoblastic leukemia at selected doses; To further evaluate the immunogenicity of YK012 in patients with B-cell acute lymphoblastic leukemia. (3) Exploratory objectives: To explore the PD characteristics of YK012.