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

Recruiting now · Phase 2

Conditions studied: Myelofibrosis

In brief

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.

Key facts

Study ID

NCT07551427

Run by

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

People needed

51

Starts

2026-06-18

Expected to finish

2029-06-01

Last updated by the study team

2026-07-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The First Affiliated Hospital of University of Science and Technology of China — Hefei, Anhui, China (enrolling)
• Fujian Medical University Union Hospital — Fuzhou, Fujian, China (enrolling)
• Guangzhou First Municipal People's Hospital — Guangzhou, Guangdong, China (enrolling)
• The First Affiliated Hospital of Guangxi Medical University — Nanning, Guangxi, China (enrolling)
• Cangzhou People's Hospital rovince — Cangzhou, Hebei, China (enrolling)
• Affiliated Hospital of Chengde Medical College — Chengde, Hebei, China (enrolling)
• The Second Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (enrolling)
• Xingtai People's Hospital — Xingtai, Hebei, China (enrolling)
• Henan Cancer Hospital — Zhengzhou, Henan, China (enrolling)
• Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology — Wuhan, Hubei, China (enrolling)
• Union Hospital Tongji College Huazhong University of Science and Technology — Wuhan, Hubei, China (enrolling)
• Zhuzhou Central Hospital — Zhuzhou, Hunan, China (enrolling)
• Nanjing Drum Tower Hospital — Nanjin, Jiangsu, China (enrolling)
• Jiangsu Provincial Hospital of Traditional Chinese Medicine — Nanjing, Jiangsu, China (enrolling)
• The First Hospital of Jilin University — Changchun, Jilin, China (enrolling)
• Shengjing Hospital Affiliated to China Medical University — Shenyang, Liaoning, China (enrolling)
• The First Affiliated Hospital of Air Force Medical University — Xi'an, Shaanxi, China (enrolling)
• The First Affiliated Hospital of Xi'an Jiaotong University — Xi'an, Shaanxi, China (enrolling)
• Shanghai Sixth People's Hospital — Shanghai, Shanghai Municipality, China (enrolling)
• Heping Hospital Affiliated To Changzhi Medical College — Changzhi, Shanxi, China (enrolling)
• Sichuan Provincial People's Hospital — Chengdu, Sichuan, China (enrolling)
• Chinese Academy of Medical Sciences Hematology Hospital — Tianjin, Tianjin Municipality, China (enrolling)
• The First Affiliated Hospital of Xinjiang Medical University — Ürümqi, Xinjiang, China (enrolling)
• The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (enrolling)

Full record on ClinicalTrials.gov

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