What is this study of TQ05105 Tablets and TQB3617 Capsules trying to find out about Myelofibrosis?

This study is testing how well TQ05105 Tablets combined with TQB3617 Capsules work and how safe they are for treating intermediate- and high-risk Myelofibrosis. The research aims to find the right dose and see if these medicines can reduce spleen size and improve symptoms. It is sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Who may be eligible for this Myelofibrosis clinical trial?

Adults aged 18 or older diagnosed with intermediate- or high-risk Myelofibrosis may be eligible. Both men and women can join if they meet health and symptom criteria and can follow study requirements. Please review eligibility criteria for more details.

Is there any cost to participate in this Myelofibrosis clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered. Participants should plan accordingly.

Actively Recruiting

Phase 1

Phase 2

Age: 18Years +

All Genders

ID06122831

Phase IbII Study of TQ05105 Tablets and TQB3617 Capsules for Treating Intermediate- and High-Risk Myelofibrosis

Led by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Updated on 2025-12-08

Participants Needed

Research Sites

17 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of TQ05105 Tablets combined with TQB3617 Capsules in people with intermediate- and high-risk Myelofibrosis, a type of bone marrow cancer. This open, single-arm, multi-center clinical trial is sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. and aims to find the best dose and measure improvements in spleen size and symptoms over time. Participants will take TQ05105 Tablets, which target Janus kinase 1 and 2 enzymes, together with TQB3617 Capsules, which inhibit bromodomain and extra-terminal proteins. Both medications are taken orally in 21-day treatment cycles. The study includes an initial phase to determine the maximum tolerated dose and recommended dose, followed by longer evaluation periods lasting up to 120 weeks. During the study, participants will undergo regular assessments including measurement of spleen volume, symptom questionnaires, gene mutation analysis, and monitoring of side effects. The main outcomes focus on spleen volume reduction and symptom improvement, as well as survival and safety over the study period. Total participation may last up to two years, with ongoing monitoring to evaluate treatment response and tolerability.

CONDITIONS

Brief Title

A Clinical Trial of TQ05105 Tablets Combined With TQB3617 Capsules in the Treatment of Myelofibrosis (MF)

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Volunteers who provide signed informed consent and can comply with study requirements
Age 18 years or older at consent
ECOG performance status score of 0 to 2
Life expectancy of at least 24 weeks
Diagnosed with primary myelofibrosis, post polycythemia vera myelofibrosis, or post essential thrombocythemia myelofibrosis
Classified as intermediate or high risk of bone marrow fibrosis by DIPSS
Meet symptom score requirements within 7 days before first treatment
Either have poor response to JAK inhibitors (for certain study cohorts) or no prior JAK inhibitor treatment (for another cohort)
Presence of spleen enlargement
Peripheral blood and bone marrow primary cells at 10% or less
No growth factor, colony stimulating factor, thrombopoietin, or platelet transfusion within 2 weeks before testing
Normal routine blood tests within 7 days before first treatment
Normal main organ function
Agree to use effective contraception during the study and for 6 months after if of childbearing potential
Negative serum HCG test within 7 days before first treatment and not breastfeeding

You will not qualify if you...

Previous allogeneic stem cell transplantation or autologous stem cell transplantation within 3 months, or planned transplantation
Prior treatment with BET inhibitors combined with JAK inhibitors
Previous splenectomy or splenic radiotherapy within 6 months before treatment
Use of myelofibrosis medications, immunomodulators, or immunosuppressants within 2 weeks before treatment
Other cancers within 3 years or currently active
Conditions affecting oral drug absorption or swallowing
Major surgery or significant injury within 4 weeks before treatment
Congenital bleeding or coagulation disorders
Arterial or venous thrombosis within 6 months before treatment
History of substance abuse or mental disorders
Active or uncontrolled severe infection
Active hepatitis B or C infection or active COVID-19
Severe heart failure or unstable heart conditions within 6 months before treatment
Poor blood pressure control despite treatment
Renal failure requiring dialysis
Newly diagnosed pulmonary fibrosis or drug-related lung disease within 3 months
History of immunodeficiency or organ transplantation
Epilepsy requiring treatment
Use of certain traditional Chinese anti-tumor medicines within 2 weeks before treatment
Uncontrolled pleural, pericardial effusions or ascites
Recent or planned live attenuated vaccine within 4 weeks before treatment
Known allergy to study drugs or ingredients
Active autoimmune diseases within 2 years before treatment
Participation in other anti-tumor drug trials within 4 weeks before treatment (except JAK inhibitor trials)
Any condition judged by investigators to threaten safety or study completion

Research Team

Chunkang Chang, Doctor

Luxi Song, Master

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Phase IbII Study of TQ05105 Tablets and TQB3617 Capsules for Treating Intermediate- and High-Risk Myelofibrosis

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria