Actively Recruiting
A Phase Ib/II Clinical Trial of TQ05105 Tablets Combined With TQB3617 Capsules in the Treatment of Intermediate- and High-risk Myelofibrosis
Led by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Updated on 2025-12-08
92
Participants Needed
22
Research Sites
17 weeks
Total Duration
On this page
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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 120 weeks
Participants receive TQ05105 Tablets combined with TQB3617 Capsules in repeated 21-day cycles as active treatment for myelofibrosis.
Repeated visits every 21 days for treatment cycles
Trial Site Locations
Total: 22 locations
1
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 525000
Not Yet Recruiting
2
Guangxi Zhuang Autonomous Region People's Hospital
Nanning, Guangxi, China, 530016
Not Yet Recruiting
3
Cangzhou People's Hosipital
Cangzhou, Hebei, China, 061014
Not Yet Recruiting
4
Affiliated Hospital of Chengde Medical College
Chengde, Hebei, China, 067020
Not Yet Recruiting
5
North China of Science and Technology University Affiliated Hospital
Tangshan, Hebei, China, 063000
Not Yet Recruiting
6
Xingtai People's Hospital
Xingtai, Hebei, China, 054031
Not Yet Recruiting
7
The First Hospital of Harbin
Harbin, Heilongjiang, China, 150010
Not Yet Recruiting
8
Henan Cancer Hospital
Zhengzhou, Henan, China, 450003
Not Yet Recruiting
9
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, China, 430071
Not Yet Recruiting
10
Union Hospital Tongji College Huazhong Unizersity of Science And Technology
Wuhan, Hubei, China, 430071
Not Yet Recruiting
11
Wuhan University Zhongnan Hospital
Wuhan, Hubei, China, 430071
Not Yet Recruiting
12
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, Inner Mongolia, China, 010000
Not Yet Recruiting
13
The Public Hospital of Wuxi
Wuxi, Jiangsu, China, 214000
Not Yet Recruiting
14
The First Hospital of Jilin University
Changchun, Jilin, China, 130021
Not Yet Recruiting
15
Xi 'An Jiaotong University Second Affiliated Hospital
Xi'an, Shaanxi, China, 710000
Not Yet Recruiting
16
Tai'an City Central Hospital
Tai’an, Shandong, China, 271099
Not Yet Recruiting
17
Central Hospital Of Minhang District, Shanghai
Shanghai, Shanghai Municipality, China, 200000
Not Yet Recruiting
18
Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
19
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, China, 200233
Actively Recruiting
20
Heping Hospital Affiliated to Changzhi Medical College
Changzhi, Shanxi, China, 046000
Not Yet Recruiting
21
People's Hospital of Tianjin City
Tianjin, Tianjin Municipality, China, 300122
Not Yet Recruiting
22
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China, 830011
Not Yet Recruiting
Research Team
C
Chunkang Chang, Doctor
L
Luxi Song, Master
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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