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Doctor","13958122357","hongyantong@aliyun.com",{"type":369,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100635341",false,"NCT07551427","A Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of TQ05105 Tablets in Subjects With Intermediate\u002FHigh-risk Myelofibrosis","A Phase II, Single-arm, Open-label, Multicenter Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of TQ05105 Tablets in Subjects With Intermediate\u002FHigh-risk Myelofibrosis","Inclusion Criteria:\n\n1. Voluntary and signed informed consent, good compliance.\n2. Age ≥18 years (at time of signing informed consent); Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2; life expectancy ≥24 weeks.\n3. Diagnosis of primary myelofibrosis (PMF) per World Health Organization (WHO) 2016, or post-polycythemia vera myelofibrosis (post-PV-MF) or post-essential thrombocythemia myelofibrosis (post-ET-MF) per International Working Group for Myelofibrosis Research and Treatment (IWG-MRT) criteria; Janus kinase 2 (JAK2) mutation status not restricted.\n4. Intermediate or high risk per Dynamic International Prognostic Scoring System (DIPSS).\n5. Cohort 1: Renal function classified as normal, mild impairment, or moderate impairment. Cohort 2: Prior Janus kinase (JAK) inhibitor therapy with refractory, relapsed, or intolerant.\n6. Spleen enlargement (except Cohort 1).\n7. Peripheral blood and bone marrow blasts ≤10%.\n8. No growth factors, colony-stimulating factors, thrombopoietin, or platelet transfusion within 2 weeks before first dose; and routine blood parameters meet requirements within 7 days before first dose.\n9. Adequate major organ function within 7 days before first dose per protocol (renal function not restricted for Cohort 1).\n10. Agreement to use effective contraception during the study and for 6 months after; negative pregnancy test for females of childbearing potential; non-lactating.\n\nExclusion Criteria:\n\n1. Prior allogeneic stem cell transplantation, or autologous stem cell transplantation within 3 months before first dose, or planned stem cell transplantation.\n2. Prior treatment with 2 or more Janus kinase (JAK) inhibitors (except Cohort 1).\n3. Prior splenectomy or splenic radiotherapy within 6 months before first dose.\n4. Other malignancies within 3 years before first dose or currently present (exceptions per protocol).\n5. Factors affecting oral drug absorption.\n6. Non-hematologic toxicity from prior therapy not recovered to ≤ grade 1 (excluding hypertension and alopecia).\n7. Major surgery or significant traumatic injury within 4 weeks before first dose.\n8. Congenital bleeding or coagulation disorders.\n9. Arterial\u002Fvenous thrombosis event within 6 months before first dose.\n10. History of substance abuse or mental disorder.\n11. Active or uncontrolled severe infection.\n12. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.\n13. Grade ≥2 myocardial ischemia or infarction, arrhythmia, QT prolongation, or grade ≥2 congestive heart failure.\n14. Uncontrolled hypertension despite standard therapy.\n15. Renal failure requiring hemodialysis or peritoneal dialysis.\n16. Newly diagnosed pulmonary interstitial fibrosis or drug-related interstitial lung disease within 3 months before first dose.\n17. History of immunodeficiency or organ transplantation.\n18. Epilepsy requiring treatment.\n19. Use of protocol-prohibited myelofibrosis (MF) medications, immunomodulators, or immunosuppressants within specified time before first dose.\n20. Use of Chinese patent medicines with anti-tumor indications approved by National Medical Products Administration (NMPA) within 2 weeks before first dose.\n21. Uncontrolled pleural effusion, pericardial effusion, or ascites.\n22. Live attenuated vaccine within 4 weeks before first dose or planned during the study.\n23. Known hypersensitivity to study drug or excipients.\n24. Diagnosis of active autoimmune disease within 2 years before first dose.\n25. Participation in another interventional clinical trial with investigational drug within 4 weeks before first dose.\n26. Any condition that, in the investigator's judgment, seriously endangers subject safety or interferes with study completion.","ALL","18 Years",{"count":379,"type":380},51,"ESTIMATED","INTERVENTIONAL",[383],"PHASE2","This is an open-label, single-arm, multi-center phase II study consisting of two cohorts. Cohort 1 evaluates the pharmacokinetics (PK) of TQ05105 in myelofibrosis participants with normal, mild, or moderate renal impairment to guide dosing. Cohort 2 evaluates the efficacy and safety of TQ05105 in participants with intermediate\u002Fhigh-risk myelofibrosis who are refractory, relapsed, or intolerant to prior Janus kinase (JAK) inhibitor therapy.",[386],"Myelofibrosis","NOT_YET_RECRUITING","2026-04-22",{"date":390,"type":391},"2026-04-24","ACTUAL",{"date":393,"type":380},"2026-05",{"date":395,"type":380},"2029-06",{"name":5,"class":6},24]