TGRX-678 Chinese Phase I in Chronic Myelogenous Leukemia (CML) Patients

Inclusion Criteria: * Willing to participate in the study with informed consent; * 18-75 years of age at the time of screening; * Male or female; * Diagnosis of CML-CP by cytomorphological examination of the bone marrow, molecular biology examination, or cytogenetic testing during the screening period (according to the NCCN guidelines (NCCN, 2021); * Received prior treatment with imatinib, dasatinib or nilotinib; patients must be intolerant or resistant to the above drugs according to MD Anderson or ELN guidelines; * ECOG performance status ≤ 2; * Minimum life expectancy of 3 months; * Adequate renal function, defined as serum creatinine \<1.5× upper limit of normality (ULN) * Adequate liver function, defined as total bilirubin \<1.5× ULN, AST and ALT \<2.5×ULN; if liver function is compromised due to CML, AST and ALT \<5×ULN; * Adequate coagulation function, defined as PT\<1.5×ULN, INR\<1.5×ULN, and APTT\<1.5×ULN; * Normal pancreatic function, defined as lipase and amylase \<1.5× ULN; * Normal QTc interval, defined as ≤450 ms in males and ≤470 ms in females, as indicated by ECG screening results; * For women with child-bearing potential, negative pregnancy test result at screening period; * Pregnant or breast feeding and female patients of childbearing potential must agree to use effective methods of contraception. Exclusion Criteria: * Received TKI treatment within 7 days of first dosing of the investigational drug, or AEs related to previous treatment has not been recov…