Actively Recruiting
A Clinical Trial of TQ05105 Tablets Combined With TQB3617 Capsules in the Treatment of Myelofibrosis (MF)
Led by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Updated on 2025-12-08
92
Participants Needed
22
Research Sites
172 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open, single-arm, multi-center clinical study designed to evaluate the efficacy and safety of TQ05105 Tablets combined with TQB3617 Capsules in patients with intermediate- and high-risk Myelofibrosis.
CONDITIONS
Official 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...
- Voluntary and signed informed consent with good compliance
- Age 18 or above at consent signing with 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 by the dynamic international prognostic scoring system for bone marrow fibrosis
- Symptom score of myeloproliferative neoplasms meeting requirements within 7 days before first dose
- Poor response to JAK inhibitors (for phase Ib and phase II cohort 2 and 3) or no prior JAK inhibitor treatment (for phase II cohort 1)
- 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 examination; blood routine indexes meeting requirements within 7 days before first dose
- Normal main organ function
- Men and women of childbearing potential agree to use contraception during the study and for 6 months after; negative serum human chorionic gonadotrophin test within 7 days before first dose; not breastfeeding
You will not qualify if you...
- Previous allogeneic stem cell transplantation or autologous stem cell transplantation within 3 months before first dose, or planned stem cell transplantation
- Prior treatment with BET inhibitors combined with JAK inhibitors
- Previous splenectomy or splenic radiotherapy within 6 months before first dose
- Use of any myelofibrosis medications, immunomodulators, or immunosuppressive agents within 2 weeks before first dose
- Other malignancies within 3 years prior to first dose or currently present
- Conditions affecting oral drug absorption such as inability to swallow, gastrointestinal resection, diarrhea, or intestinal obstruction
- Major surgery or significant trauma within 4 weeks before first dose
- Congenital bleeding disorders or coagulopathy
- Arterial or venous thrombosis within 6 months before first dose
- History of mental drug abuse or mental disorder
- Active or uncontrolled severe infection
- Active hepatitis B or C infection or active COVID-19 infection
- Severe heart conditions including grade III or higher heart failure, unstable angina, myocardial infarction, arrhythmia needing treatment, or QT interval prolongation within 6 months before first dose
- Poor blood pressure control despite treatment
- Renal failure requiring 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 Chinese patent anti-tumor medicines within 2 weeks before first dose
- Uncontrolled pleural, pericardial effusion, or ascites
- Live vaccine within 4 weeks before first dose or planned during the study
- Known allergy to study drugs or excipients
- Active autoimmune diseases within 2 years before first dose
- Participation in other anti-tumor clinical trials within 4 weeks before first dose (except JAK inhibitor trials)
- Any condition deemed by investigators to seriously endanger safety or study completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
L
Luxi Song, Master
CONTACT
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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