[Translation] An open, single-arm, multicenter Phase I clinical study to evaluate the safety and preliminary efficacy of NK042 cell injection (universal NKR+NK) in advanced solid tumors
主要目的:评价NK042细胞注射液治疗晚期实体瘤患者的安全性和耐受性,观察可能出现的剂量限制性毒性(DLT),以及确定最大耐受剂量(MTD)和/或II期临床试验推荐剂量(RP2D)。
次要目的:描述NK042细胞注射液输注人体后的药代动力学(PK)特征,观察其在体内的增殖和持续性;初步评价NK042细胞注射液治疗晚期实体瘤肿瘤患者的疗效;评价NK042的免疫原性以及输注人体后对人体免疫系统的影响。
[Translation] Primary purpose: To evaluate the safety and tolerability of NK042 cell injection in the treatment of patients with advanced solid tumors, observe possible dose-limiting toxicity (DLT), and determine the maximum tolerated dose (MTD) and/or recommended dose (RP2D) for Phase II clinical trials.
Secondary purpose: To describe the pharmacokinetic (PK) characteristics of NK042 cell injection after infusion into humans, and observe its proliferation and persistence in vivo; to preliminarily evaluate the efficacy of NK042 cell injection in the treatment of patients with advanced solid tumors; to evaluate the immunogenicity of NK042 and its effects on the human immune system after infusion into humans.