[Translation] An open, multicenter phase I clinical study to evaluate the safety, tolerability and preliminary efficacy of IBR733 cell injection in the treatment of acute myeloid leukemia
主要研究目的:评估复发/难治性AML受试者接受IBR733细胞注射液治疗的安全性和耐受性;确定复发/难治性AML受试者接受IBR733细胞注射液治疗的推荐的II期剂量(RP2D)。次要研究目的:初步评估复发/难治性AML受试者接受IBR733细胞注射液治疗的疗效;IBR733细胞注射液在复发/难治性AML受试者中的药代动力学(PK)特征;评估IBR733细胞注射液在复发/难治性AML受试者中的免疫原性。探索性目的:探索IBR733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;回顾性分析骨髓CD33及C-型凝集素样分子1(CLL-1)表达百分比和疗效的关系。
[Translation] The main study objectives are to evaluate the safety and tolerability of IBR733 cell injection in subjects with relapsed/refractory AML; to determine the recommended Phase II dose (RP2D) of IBR733 cell injection in subjects with relapsed/refractory AML. Secondary study objectives are to preliminarily evaluate the efficacy of IBR733 cell injection in subjects with relapsed/refractory AML; to characterize the pharmacokinetic (PK) characteristics of IBR733 cell injection in subjects with relapsed/refractory AML; to evaluate the immunogenicity of IBR733 cell injection in subjects with relapsed/refractory AML. Exploratory objectives are to explore the relationship between the degree of matching between human leukocyte antigen (HLA) and killer cell immunoglobulin-like receptor (KIR) of natural killer cell (NK) donors and recipients in IBR733 and the efficacy; to retrospectively analyze the relationship between the percentage of bone marrow CD33 and C-type lectin-like molecule 1 (CLL-1) expression and the efficacy.