TQ05105 tablets for intermediate/high-risk myelofibrosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open-label, multi-center, single-arm phase II trial with two cohorts. Cohort 1 studies the drug’s pharmacokinetics in people with different levels of kidney function to guide dosing. Cohort 2 tests the drug’s efficacy and safety in patients who are refractory, relapsed, or intolerant to prior JAK inhibitor therapy. Eligible adults have confirmed myelofibrosis, adequate organ function, and meet risk criteria. Primary goals include understanding dosing and potential clinical benefit, with safety as a key consideration.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Voluntary and signed informed consent, good compliance.
2. Age ≥18 years (at time of signing informed consent); Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2; life expectancy ≥24 weeks.
3. 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.
4. Intermediate or high risk per Dynamic International Prognostic Scoring System (DIPSS).
5. 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.
6. Spleen enlargement (except Cohort 1).
7. Peripheral blood and bone marrow blasts ≤10%.
8. 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.
9. Adequate major organ function within 7 days before first dose per protocol (renal function not restricted for Cohort 1).
10. Agreement to use effective contraception during the study and for 6 months after; negative pregnancy test for females of childbearing potential; non-lactating.

Exclusion Criteria:

1. Prior allogeneic stem cell transplantation, or autologous stem cell transplantation within 3 months before first dose, or planned stem cell transplantation.
2. Prior treatment with 2 or more Janus kinase (JAK) inhibitors (except Cohort 1).
3. Prior splenectomy or splenic radiotherapy within 6 months before first dose.
4. Other malignancies within 3 years before first dose or currently present (exceptions per protocol).
5. Factors affecting oral drug absorption.
6. Non-hematologic toxicity from prior therapy not recovered to ≤ grade 1 (excluding hypertension and alopecia).
7. Major surgery or significant traumatic injury within 4 weeks before first dose.
8. Congenital bleeding or coagulation disorders.
9. Arterial/venous thrombosis event within 6 months before first dose.
10. History of substance abuse or mental disorder.
11. Active or uncontrolled severe infection.
12. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
13. Grade ≥2 myocardial ischemia or infarction, arrhythmia, QT prolongation, or grade ≥2 congestive heart failure.
14. Uncontrolled hypertension despite standard therapy.
15. Renal failure requiring hemodialysis or peritoneal dialysis.
16. Newly diagnosed pulmonary interstitial fibrosis or drug-related interstitial lung disease within 3 months before first dose.
17. History of immunodeficiency or organ transplantation.
18. Epilepsy requiring treatment.
19. Use of protocol-prohibited myelofibrosis (MF) medications, immunomodulators, or immunosuppressants within specified time before first dose.
20. Use of Chinese patent medicines with anti-tumor indications approved by National Medical Products Administration (NMPA) within 2 weeks before first dose.
21. Uncontrolled pleural effusion, pericardial effusion, or ascites.
22. Live attenuated vaccine within 4 weeks before first dose or planned during the study.
23. Known hypersensitivity to study drug or excipients.
24. Diagnosis of active autoimmune disease within 2 years before first dose.
25. Participation in another interventional clinical trial with investigational drug within 4 weeks before first dose.
26. Any condition that, in the investigator's judgment, seriously endangers subject safety or interferes with study completion.

Where it's running

• The First Affiliated Hospital of University of Science and Technology of China
  Hefei, Anhui, China Recruiting
• Fujian Medical University Union Hospital
  Fuzhou, Fujian, China Recruiting
• Guangzhou First Municipal People's Hospital
  Guangzhou, Guangdong, China Recruiting
• The First Affiliated Hospital of Guangxi Medical University
  Nanning, Guangxi, China Recruiting
• Cangzhou People's Hospital rovince
  Cangzhou, Hebei, China Recruiting
• Affiliated Hospital of Chengde Medical College
  Chengde, Hebei, China Recruiting

Study contacts

• Study coordinator: Chunkang Chang, Doctor
• Email: changchunkang7010@aliyun.com
• Phone: 13764643870

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• National registry for people with myelofibrosis and anemia in Germany.

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• Evaluating DISC-0974 for treating anemia in myelofibrosis patients

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• Elritercept vs. placebo for adults with myelofibrosis and anemia on ruxolitinib

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• Ropeginterferon add-on to ruxolitinib in myelofibrosis

  This trial tests whether adding ropeginterferon alfa-2b to ongoing ruxolitinib treatment is safe and helpful for adults with myelofibrosis.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.