Yingbairui (Hangzhou) Biomedical Co., Ltd.

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.

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.