Tests TQ05105 tablets in adults with intermediate or high-risk myelofibrosis
Tests TQ05105 tablets in adults with myelofibrosis who did not respond to earlier JAK inhibitors.
Plain-language title generated from the registry record
Registry title: A Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of TQ05105 Tablets in Subjects With Intermediate/High-risk Myelofibrosis
Key facts
- Where
- Cangzhou, Changchun, Changzhi, Chengde, Chengdu, Fuzhou, Guangzhou, Hangzhou, Hefei, Nanjin, Nanjing, Nanning, Shanghai, Shenyang, Shijiazhuang, Tianjin, Ürümqi, Wuhan, Xi’an, Xingtai, Zhengzhou, and Zhuzhou, ChinaSee the 24 sites
- Phase
- Phase 2
Where in China
- Cangzhou People's Hospital rovinceCangzhou, ChinaTaking people
- The First Hospital of Jilin UniversityChangchun, ChinaTaking people
- Heping Hospital Affiliated to Changzhi Medical CollegeChangzhi, ChinaTaking people
- Affiliated Hospital of Chengde Medical CollegeChengde, ChinaTaking people
- Sichuan Provincial People's HospitalChengdu, ChinaTaking people
- Fujian Medical University Union HospitalFuzhou, ChinaTaking people
- Guangzhou First Municipal People's HospitalGuangzhou, ChinaTaking people
- The First Affiliated Hospital Zhejiang University School of MedicineHangzhou, ChinaTaking people
- The First Affiliated Hospital of University of Science and Technology of ChinaHefei, ChinaTaking people
- Nanjing Drum Tower HospitalNanjin, ChinaTaking people
- Jiangsu Provincial Hospital of Traditional Chinese MedicineNanjing, ChinaTaking people
- The First Affiliated Hospital of Guangxi Medical UniversityNanning, ChinaTaking people
- Shanghai Sixth People's HospitalShanghai, ChinaTaking people
- Shengjing Hospital affiliated to China Medical UniversityShenyang, ChinaTaking people
- The Second Hospital of Hebei Medical UniversityShijiazhuang, ChinaTaking people
- Chinese Academy of Medical Sciences Hematology HospitalTianjin, ChinaTaking people
- The First Affiliated Hospital of Xinjiang Medical UniversityÜrümqi, ChinaTaking people
- Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & TechnologyWuhan, ChinaTaking people
- Union Hospital Tongji College Huazhong University of Science and TechnologyWuhan, ChinaTaking people
- The First Affiliated Hospital of Air Force Medical UniversityXi’an, ChinaTaking people
- The First Affiliated Hospital of Xi'an Jiaotong UniversityXi’an, ChinaTaking people
- Xingtai People's HospitalXingtai, ChinaTaking people
- Henan Cancer HospitalZhengzhou, ChinaTaking people
- Zhuzhou Central HospitalZhuzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Trial code
- NCT07551427
- Record updated
- 15 July 2026
- Original description
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/high-risk myelofibrosis who are refractory, relapsed, or intolerant to prior Janus kinase (JAK) inhibitor therapy.Read full original descriptionShow less
A Phase II, Single-arm, Open-label, Multicenter Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of TQ05105 Tablets in Subjects With Intermediate/High-risk Myelofibrosis
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/high-risk myelofibrosis who are refractory, relapsed, or intolerant to prior Janus kinase (JAK) inhibitor therapy.
Inclusion: Voluntary and signed informed consent, good compliance; Age ≥18 years (at time of signing informed consent); Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2; life expectancy ≥24 weeks; 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; Intermediate or high risk per Dynamic International Prognostic Scoring System (DIPSS); 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; Spleen enlargement (except Cohort 1); Peripheral blood and bone marrow blasts ≤10%; 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; Adequate major organ function within 7 days before first dose per protocol (renal function not restricted for Cohort 1); Agreement to use effective contraception during the study and for 6 months after; negative pregnancy test for females of childbearing potential; non-lactating.
Exclusion: 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; 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; Arterial/venous thrombosis event within 6 months before first dose; Newly diagnosed pulmonary interstitial fibrosis or drug-related interstitial lung disease within 3 months before first dose; 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; Live attenuated vaccine within 4 weeks before first dose or planned during the study; Participation in another interventional clinical trial with investigational drug within 4 weeks before first dose; Other malignancies within 3 years before first dose or currently present (exceptions per protocol); Congenital bleeding or coagulation disorders; History of substance abuse or mental disorder; Active or uncontrolled severe infection; Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection; Uncontrolled hypertension despite standard therapy; Renal failure requiring hemodialysis or peritoneal dialysis; History of immunodeficiency or organ transplantation; Epilepsy requiring treatment; Known hypersensitivity to study drug or excipients; Diagnosis of active autoimmune disease within 2 years before first dose; Any condition that, in the investigator's judgment, seriously endangers subject safety or interferes with study completion; Grade ≥2 myocardial ischemia or infarction, arrhythmia, QT prolongation, or grade ≥2 congestive heart failure; Uncontrolled pleural effusion, pericardial effusion, or ascites.