[Translation] A Phase I clinical study to evaluate the safety, tolerability and preliminary efficacy of IBR854 cell injection in patients with unresectable locally advanced or metastatic solid tumors
主要目的:评价IBR854细胞注射液的安全性和耐受性;确定IBR854细胞注射液推荐的II期剂量(RP2D)和/或最大耐受剂量(MTD)。次要目的:初步评价IBR854细胞注射液在不可切除的局部晚期或转移性实体瘤患者中的抗肿瘤疗效;描述IBR854细胞注射液的药代动力学(PK)特征;评估IBR854细胞注射液的免疫原性。探索性目的:探索IBR854中的自然杀伤细胞(NK)供者和受者人类白细胞抗原(HLA)及杀伤细胞免疫球蛋白样受体(KIR)匹配程度和疗效的关系;回顾性分析肿瘤抗原5T4表达情况和疗效的相关性。
[Translation] Primary objectives: To evaluate the safety and tolerability of IBR854 cell injection; to determine the recommended phase II dose (RP2D) and/or maximum tolerated dose (MTD) of IBR854 cell injection. Secondary objectives: To preliminarily evaluate the anti-tumor efficacy of IBR854 cell injection in patients with unresectable locally advanced or metastatic solid tumors; to describe the pharmacokinetic (PK) characteristics of IBR854 cell injection; and to evaluate the immunogenicity of IBR854 cell injection. Exploratory objectives: To explore the relationship between the matching degree of human leukocyte antigen (HLA) and killer cell immunoglobulin-like receptor (KIR) between natural killer cell (NK) donors and recipients in IBR854 and the efficacy; and to retrospectively analyze the correlation between the expression of tumor antigen 5T4 and the efficacy.