A Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of TQ05105 Tablets in Subjects With Intermediate/High-risk Myelofibrosis

Exclusion Criteria26

• Prior allogeneic stem cell transplantation, or autologous stem cell transplantation within 3 months before first dose, or planned stem cell transplantation.
• Prior treatment with 2 or more Janus kinase (JAK) inhibitors (except Cohort 1).
• Prior splenectomy or splenic radiotherapy within 6 months before first dose.
• Other malignancies within 3 years before first dose or currently present (exceptions per protocol).
• Factors affecting oral drug absorption.
• Non-hematologic toxicity from prior therapy not recovered to ≤ grade 1 (excluding hypertension and alopecia).
• Major surgery or significant traumatic injury within 4 weeks before first dose.
• Congenital bleeding or coagulation disorders.
• Arterial/venous thrombosis event within 6 months before first dose.
• History of substance abuse or mental disorder.
• Active or uncontrolled severe infection.
• Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
• Grade ≥2 myocardial ischemia or infarction, arrhythmia, QT prolongation, or grade ≥2 congestive heart failure.
• Uncontrolled hypertension despite standard therapy.
• Renal failure requiring hemodialysis or peritoneal dialysis.
• Newly diagnosed pulmonary interstitial fibrosis or drug-related interstitial lung disease within 3 months before first dose.
• History of immunodeficiency or organ transplantation.
• Epilepsy requiring treatment.
• Use of protocol-prohibited myelofibrosis (MF) medications, immunomodulators, or immunosuppressants within specified time before first dose.
• Use of Chinese patent medicines with anti-tumor indications approved by National Medical Products Administration (NMPA) within 2 weeks before first dose.
• Uncontrolled pleural effusion, pericardial effusion, or ascites.
• Live attenuated vaccine within 4 weeks before first dose or planned during the study.
• Known hypersensitivity to study drug or excipients.
• Diagnosis of active autoimmune disease within 2 years before first dose.
• Participation in another interventional clinical trial with investigational drug within 4 weeks before first dose.
• Any condition that, in the investigator's judgment, seriously endangers subject safety or interferes with study completion.