[Translation] A single-arm, prospective, open-label, phase I clinical study of allogeneic NK cell injection (code name: ZMPB-NK006 injection) for the treatment of patients with advanced or metastatic malignant solid tumors.
主要目的:评估ZMPB-NK006注射液在晚期或转移性恶性实体肿瘤患者中的安全性和耐受性。次要目的:评估ZMPB-NK006注射液在晚期或转移性恶性实体肿瘤患者中的药代动力学(PK)特征;评估ZMPB-NK006注射液在晚期或转移性恶性实体肿瘤患者中的免疫原性;评估ZMPB-NK006注射液在晚期或转移性恶性实体肿瘤患者中的初步抗肿瘤活性。探索性目的:探索ZMPB-NK006注射液在晚期或转移性恶性肿瘤患者中的药效学,以及与ZMPB-NK006注射液的疗效和安全性之间的相关性。
[Translation] Primary objective: To evaluate the safety and tolerability of ZMPB-NK006 injection in patients with advanced or metastatic malignant solid tumors. Secondary objectives: To evaluate the pharmacokinetic (PK) characteristics of ZMPB-NK006 injection in patients with advanced or metastatic malignant solid tumors; to evaluate the immunogenicity of ZMPB-NK006 injection in patients with advanced or metastatic malignant solid tumors; and to evaluate the preliminary antitumor activity of ZMPB-NK006 injection in patients with advanced or metastatic malignant solid tumors. Exploratory objective: To explore the pharmacodynamics of ZMPB-NK006 injection in patients with advanced or metastatic malignant tumors, and its correlation with the efficacy and safety of ZMPB-NK006 injection.