A Clinical Trial of TQ05105 Tablets Combined With TQB3617 Capsules in the Treatment of Myelofibrosis (MF)

Exclusion Criteria25

• Patients who have previously received allogeneic stem cell transplantation, or received autologous stem cell transplantation within 3 months before the first administration, or recently planned stem cell transplantation;
• Previous treatment with BET inhibitors combined with JAK inhibitor;
• Patients who have previously undergone splenectomy, or received splenic radiotherapy within 6 months before the first administration;
• Use of any MF medications, any immunomodulators, any immunosuppressive agents, within 2 weeks prior to first administration (There are separate withdrawal requirements for hydroxyurea, JAK inhibitors, androgen drugs, erythropoietin, long-acting recombinant interferon-α, etc.);
• Other malignancies within 3 years prior to first administration or currently present.
• Patients with multiple factors (such as inability to swallow, postoperative gastrointestinal resection, acute and chronic diarrhea, intestinal obstruction, etc.) affecting oral or absorption of drugs;
• Major surgical treatment or significant traumatic injury within 4 weeks prior to first administration;
• Presence of congenital bleeding disorder and congenital coagulopathy;
• Patients who had arterial/venous thrombosis events within 6 months before the first administration.
• Have a history of mental drug abuse, or have a mental disorder.
• Active or uncontrolled severe infection;
• Active hepatitis B virus (HBV) infection, or hepatitis C virus (HCV) infection and HCV RNA positive, or active Corona Virus Disease 2019 (COVID-19) infection;
• Patients with grade III or above congestive heart failure, unstable angina pectoris or myocardial infarction, or arrhythmia requiring treatment, or QT interval prolongation within 6 months before the first administration;
• Unsatisfactory blood pressure control despite standard therapy;
• Patients with renal failure requiring hemodialysis or peritoneal dialysis;
• Patients newly diagnosed with pulmonary interstitial fibrosis or drug-related interstitial lung disease within 3 months before the first administration;
• Patients with a history of immunodeficiency disease or organ transplantation;
• Patients with epilepsy requiring treatment;
• Patients who have received Chinese patent medicines with anti-tumor indications specified in the approved drug package insert of China National Medical Products Administration (NMPA) within 2 weeks before the first administration;
• Patients with uncontrolled pleural effusion, pericardial effusion or ascites;
• There was a history of attenuated live vaccine inoculation within 4 weeks before the first administration, or attenuated live vaccine inoculation was planned during the study period.
• People with known hypersensitivity to the study drug and excipients;
• Patients diagnosed as active autoimmune diseases within 2 years before the first administration;
• Those who participated in and used other anti-tumor clinical trial drugs within 4 weeks before the first administration (except JAK inhibitor-related clinical trials).
• According to the judgment of the investigators, some situations seriously endanger the safety of the subjects or affect the subjects to complete the study.