TGRX-678

Primary objective Cohort 1: To evaluate the efficacy of TGRX-678 in the treatment of subjects with relapsed or refractory CML-AP without T315I mutation after treatment with first-generation, second-generation, and third-generation TKIs (ponatinib, orebactinib). Cohort 2: To evaluate the efficacy of TGRX-678 in the treatment of subjects with relapsed or refractory CML-AP with T315I mutation after treatment with ≥2 TKIs (including at least one third-generation TKI). Secondary objectives To further evaluate the efficacy of TGRX-678 in CML-AP subjects in cohorts 1 and 2, including hematological response, cytogenetic response, molecular response, and clinical outcomes. To evaluate the safety of TGRX-678 in CML-AP subjects. Exploratory objectives To explore the population pharmacokinetic (PopPK) characteristics of TGRX-678. To explore the correlation between gene mutations in and outside the BCR-ABL1 kinase region and drug resistance/disease progression during TGRX-678 treatment.