TQ05105 Tablet for Myelofibrosis Treatment in Ruxolitinib-Resistant or Intolerant Patients
Reason given: This study was closed due to business reasons. Closure was not prompted by any safety or efficacy concerns.
Key facts
- Where
- Changchun, Hefei, Shanghai, Wuhan, Wuhu, and Xuzhou, ChinaSee the 6 sites
- Phase
- Phase 1
Where in China
- The First Hospital of Jilin UniversityChangchun, ChinaNo longer taking part
- Anhui Provincial HospitalHefei, ChinaNo longer taking part
- Shanghai Sixth People's HospitalShanghai, ChinaNo longer taking part
- Union Hospital Tongji College Huazhong University of Science and TechnologyWuhan, ChinaNo longer taking part
- The First Affiliated Hospital of Wannan Medical CollegeWuhu, ChinaNo longer taking part
- The affiliated hospital of xuzhou medical universityXuzhou, ChinaNo longer taking part
Trial details
- Who runs it
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Trial code
- NCT06388759
- Record updated
- 29 August 2025
- Original description
This is an open, single-arm, multi-center clinical study designed to evaluate the efficacy of TQ05105 Tablets in patients with intermediate-risk and high-risk myelofibrosis.Read full original descriptionShow less
A Phase Ib Study of TQ05105 Tablets for the Treatment of Intermediate and High Risk Myelofibrosis Refractory/Relapsed/Intolerant to Ruxolitinib
This is an open, single-arm, multi-center clinical study designed to evaluate the efficacy of TQ05105 Tablets in patients with intermediate-risk and high-risk myelofibrosis.
Inclusion: Subjects voluntarily participated in this study, signed informed consent forms, and demonstrated good compliance；; Age: 18 or older (when signing the informed consent form); Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0 or 2; Life expectancy ≥ 24 weeks; Patients diagnosed with Primary myelofibrosis (PMF), post polycythemia vera myelofibrosis (post-PV MF), or post essential thrombocythemia myelofibrosis (post-ET MF); According to the dynamic international prognostic scoring system (DIPSS), patients with intermediate or high risk of bone marrow fibrosis were evaluated; Patients with poor efficacy or intolerant of Ruxolitinib; Spleen enlargement; Peripheral blood primary cells and bone marrow primary cells were ≤10%; No growth factor, colony stimulating factor, thrombopoietin or platelet transfusion was received within 2 weeks before the examination, and the blood routine indexes met the requirements within 7 days before the first administration; The Main organ function is normal; Men and women of childbearing age should agree to use contraceptive measures (such as intrauterine devices, contraceptives, or condoms) during the study period and within 6 months after the end of the study. Serum human chorionic gonadotrophin（HCG）test is not negative within 7 days before the first administration and must be non-lactating patients.
Exclusion: 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 JAK inhibitors(except ruxolitinib); Patients who have previously undergone splenectomy, or received splenic radiotherapy within 6 months before the first administration; 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; The non-hematological toxicity caused by previous treatment did not return to grade≤1; Major surgical treatment or significant traumatic injury within 4 weeks prior to first administration; Patients who had arterial/venous thrombosis events within 6 months before the first administration; Unsatisfactory blood pressure control despite standard therapy; Patients newly diagnosed with pulmonary interstitial fibrosis or drug-related interstitial lung disease within 3 months before the first administration; Use of any MF medications, any immunomodulators, androgens, any immunosuppressive agents, erythropoietin, aspirin > 100 mg/day within 2 weeks prior to first administration; 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; 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; Those who participated in and used other anti-tumor clinical trial drugs within 4 weeks before the first administration; Presence of congenital bleeding disorder and congenital coagulopathy; 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; Patients with renal failure requiring hemodialysis or peritoneal dialysis; Patients with a history of immunodeficiency disease or organ transplantation; Patients with epilepsy requiring treatment; People with known hypersensitivity to the study drug and excipients; Patients diagnosed as active autoimmune diseases within 2 years before the first administration; Patients with ≥ grade 2 myocardial ischemia or myocardial infarction, arrhythmia, QT interval prolongation and ≥ grade 2 congestive heart failure; Patients with uncontrolled pleural effusion, pericardial effusion or ascites; According to the judgment of the investigators, some situations seriously endanger the safety of the subjects or affect the subjects to complete the study.