MyelofibrosisPhase 2NCT07551427
A Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of TQ05105 Tablets in Subjects With Intermediate/High-risk Myelofibrosis
A Phase 2 study testing TQ05105 Tablets (Rovadicitinib Tablets) in people with Myelofibrosis, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 24 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myelofibrosis
- What is being tested?
- TQ05105 Tablets (Rovadicitinib Tablets)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 24 sitesChina
- Study dates
- 18 Jun 2026to Jun 2029
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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).
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- 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.
- Any condition that, in the investigator's judgment, seriously endangers subject safety or interferes with study completion.
Trial locations and contacts
24 sites in 1 country. Contact the study team or a site near you to ask about taking part.
24 sites in 1 country
China24 sites, 24 recruiting
- Recruiting
Cangzhou People's Hospital rovince
Cangzhou, Hebei, 061014
Hongmei Ma, Master, 18031798229, mhm-sspc@163.com
- Recruiting
The First Hospital of Jilin University
Changchun, Jilin, 130021
Sujun Gao, Doctor, 15843073208, sujung1963@163.com
- Recruiting
Heping Hospital Affiliated To Changzhi Medical College
Changzhi, Shanxi, 046000
Xuliang Shen, Doctor, 13015365546, shenxlcyp@sohu.com
- Recruiting
Affiliated Hospital of Chengde Medical College
Chengde, Hebei, 067000
Zhihua Zhang, Master, 15633142905, zzhangzhihua@163.com
- Recruiting
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610000
Xiaobing Huang, Doctor, 18981838236, hxb_trial@163.com
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Yong Wu, Doctor, 13365910911, wuyong9195@126.com
- Recruiting
Guangzhou First Municipal People's Hospital
Guangzhou, Guangdong, 510180
Shunqing Wang, Doctor, 13437807998, drwangshq@medmail.com.cn
- Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310003
Hongyan Tong, Doctor, 13958122357, hongyantong@aliyun.com
- Recruiting
The First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, 230001
Xiaoyu Zhu, Doctor, 15255456091, xiaoyuz@ustc.edu.cn
- Recruiting
Nanjing Drum Tower Hospital
Nanjin, Jiangsu, 210000
Bing Chen, Doctor, 13951806490, chenbinggcp@163.com
- Recruiting
Jiangsu Provincial Hospital of Traditional Chinese Medicine
Nanjing, Jiangsu, 210029
Xuejun Zhu, Doctor, 13505152806, zhuxj2@sina.com
- Recruiting
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530000
Zhenfang Liu, Doctor, 13481082237, liuliuzhenfang@163.com
- Recruiting
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, 200233
Chunkang Chang, Doctor, 13764643870, changchunkang7010@aliyun.com
- Recruiting
Shengjing Hospital Affiliated to China Medical University
Shenyang, Liaoning, 110000
Huihan Wang, Doctor, 18940256966, wanghh@sj-hospital.org
- Recruiting
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
Xuejun Zhang, Doctor, 13722781112, zhxjhbmu@126.com
- Recruiting
Chinese Academy of Medical Sciences Hematology Hospital
Tianjin, Tianjin Municipality, 301617
Bo Jiang, Doctor, 18630810181, jiangbo@ihcams.as.cn
- Recruiting
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang, 830011
Jianping Hao, Master, 13579876416, 13579876416@163.com
- Recruiting
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, 430071
Zhenya Hong, Postdoctoral, 13476158466, hongzhenya@sina.com
- Recruiting
Union Hospital Tongji College Huazhong University of Science and Technology
Wuhan, Hubei, 430071
Min Zhang, Doctor, 15871818568, Zhangmin35@aliyun.com
- Recruiting
The First Affiliated Hospital of Air Force Medical University
Xi'an, Shaanxi, 710000
Guangxun Gao, Doctor, 13991907320, gaoguangxun@fmmu.edu.cn
- Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710000
Pengcheng He, Doctor, 18991232609, hpec_gcp@163.com
- Recruiting
Xingtai People's Hospital
Xingtai, Hebei, 054000
Zongjiu Jiao, Master, 18631921299, 1449569258@qq.com
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450000
Hu Zhou, Doctor, 13939068863, papertigerhu@163.com
- Recruiting
Zhuzhou Central Hospital
Zhuzhou, Hunan, 412000
Chanjuan Shen, Master, 18973389928, shenchanjuan@163.com
About this study
Official title: A Phase II, Single-arm, Open-label, Multicenter Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of TQ05105 Tablets in Subjects With Intermediate/High-risk Myelofibrosis
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.
- Conditions
- Myelofibrosis
- Being tested
- TQ05105 Tablets (Rovadicitinib Tablets)
- Medical subject headings
- Primary Myelofibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQ05105 Tablets (Rovadicitinib Tablets)Drug
TQ05105 is an inhibitor of Janus kinase 1 (JAK1), Janus kinase 2 (JAK2), and Rho-associated coiled-coil containing protein kinase 1 (ROCK1) and 2 (ROCK2).
| Study group | Role | What they receive |
|---|---|---|
| TQ05105 Tablets | Experimental | TQ05105 Tablets, 28 days as a treatment cycle. Receives: Drug: TQ05105 Tablets (Rovadicitinib Tablets) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with ≥35% reduction in spleen volume from baseline at week 24 (SVR35)
SVR35 at week 24 as assessed by Independent Review Committee (IRC)
Measured: up to 24 weeks
Peak concentration (Cmax)
Maximum plasma concentration of TQ05105 and its metabolite(s).
Measured: Pre-dose on Cycle 1 Day 1 and Day 7; and 15, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Cycle 1 Day 1; and 15, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 12 hours post-dose on Cycle 1 Day 7. (28 days a cycle)
Time to peak concentration (Tmax)
Time to reach maximum plasma concentration of TQ05105 and its metabolite(s).
Measured: Pre-dose on Cycle 1 Day 1 and Day 7; and 15, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Cycle 1 Day 1; and 15, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 12 hours post-dose on Cycle 1 Day 7. (28 days a cycle)
Elimination half-life (t1/2)
Half-life of TQ05105 and its metabolite(s) in plasma.
Measured: Pre-dose on Cycle 1 Day 1 and Day 7; and 15, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Cycle 1 Day 1; and 15, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 12 hours post-dose on Cycle 1 Day 7. (28 days a cycle)
Area under the curve from time 0 to last measurable concentration (AUC0-t)
AUC from time 0 to the last measurable concentration of TQ05105 and its metabolite(s).
Measured: Pre-dose on Cycle 1 Day 1 and Day 7; and 15, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Cycle 1 Day 1; and 15, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 12 hours post-dose on Cycle 1 Day 7. (28 days a cycle)
Area under the curve from time 0 to infinity (AUC0-∞)
AUC from time 0 extrapolated to infinity for TQ05105 and its metabolite(s).
Measured: Pre-dose on Cycle 1 Day 1 and Day 7; and 15, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Cycle 1 Day 1; and 15, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 12 hours post-dose on Cycle 1 Day 7. (28 days a cycle)
Total clearance (CLt)
Total body clearance of TQ05105 and its metabolite(s) from plasma.
Measured: Pre-dose on Cycle 1 Day 1 and Day 7; and 15, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Cycle 1 Day 1; and 15, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 12 hours post-dose on Cycle 1 Day 7. (28 days a cycle)
Renal clearance (CLr)
Renal clearance of TQ05105 and its metabolite(s).
Measured: Pre-dose on Cycle 1 Day 1 and Day 7; and 15, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Cycle 1 Day 1; and 15, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 12 hours post-dose on Cycle 1 Day 7. (28 days a cycle)
Apparent volume of distribution (Vd/F)
Apparent volume of distribution of TQ05105 and its metabolite(s) after oral administration.
Measured: Pre-dose on Cycle 1 Day 1 and Day 7; and 15, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Cycle 1 Day 1; and 15, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 12 hours post-dose on Cycle 1 Day 7. (28 days a cycle)
Elimination rate constant (λz)
Terminal elimination rate constant of TQ05105 and its metabolite(s).
Measured: Pre-dose on Cycle 1 Day 1 and Day 7; and 15, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 12, 24 hours post-dose on Cycle 1 Day 1; and 15, 30, 45 minutes, 1, 2, 3, 4, 6, 8, 12 hours post-dose on Cycle 1 Day 7. (28 days a cycle)
Secondary outcomes (20)
Best response rate of spleen volume reduction
Proportion of subjects with at least one occurrence of ≥35% reduction in spleen volume from baseline.
Measured: up to 48 weeks
Onset time of splenic response
The time interval from the first administration to the date when the spleen volume was reduced by ≥ 35 % from the baseline.
Measured: up to 48 weeks
Duration of maintenance of at least 35% Reduction in Spleen Volume (DoMSR)
Duration of spleen volume reduction ≥ 35% from baseline: the time between the date when the spleen volume reduction ≥ 35% from baseline occurs for the first time and the date when the spleen volume reduction < 35% from baseline.
Measured: up to 48 weeks
Percentage change in spleen volume from baseline at planned visits
Percentage change in spleen volume relative to baseline at each planned visit.
Measured: up to 48 weeks
SVR35 at each planned visit time point
Proportion of subjects with ≥35% reduction in spleen volume from baseline at each planned visit.
Measured: up to 48 weeks
The proportion of subjects whose total symptom score of Myeloproliferative neoplasm- Symptom Assessment Form- Total Symptom Score (MPN-SAF TSS) decreased by more than 50% compared with baseline.
The proportion of subjects whose total symptom score of MPN-SAF TSS decreased by more than 50% compared with baseline. Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF-TSS) is an effective tool for evaluating the disease burden of patients with myeloproliferative neoplasms. The higher the score, the more severe the symptoms. Each symptom is scored according to the severity, from asymptomatic (0 points) to the most serious (10 points), a total of 10 levels,The sum of the symptom scores is the MPN-SAF-TSS score.
Measured: up to 48 weeks
Percentage change in MPN-SAF TSS from baseline at planned visits
Percentage change in MPN-SAF TSS from baseline at planned visits.
Measured: up to 48 weeks
Proportion of subjects with at least one occurrence of ≥50% reduction in MPN-SAF TSS from baseline
Proportion of subjects with at least one occurrence of ≥50% reduction in MPN-SAF TSS from baseline.
Measured: up to 48 weeks
Time to first ≥50% reduction in MPN-SAF TSS from baseline
Time from first dose to first documentation of ≥50% reduction in MPN-SAF TSS from baseline.
Measured: up to 48 weeks
Duration of ≥50% reduction in MPN-SAF TSS from baseline
Time from first achievement of ≥50% reduction in MPN-SAF TSS to loss of this response.
Measured: up to 48 weeks
Objective response rate (ORR)
Proportion of subjects achieving complete remission (CR) or partial remission (PR).
Measured: up to 48 weeks
Progression-free survival (PFS)
The time interval from the first medication to the date of the occurrence of any of the following events, whichever occurs first, shall prevail :(1) Spleen volume increased by≥25% compared with the screening period ; (2) Death caused by any cause.
Measured: From first dose to event (up to study completion) , an average of 3 years
Leukemia free survival (LFS)
Time from first dose to leukemic transformation or death.
Measured: From first dose to event (up to study completion) , an average of 3 years
Overall Survival (OS)
OS is defined as the time from the first time the subject received treatment to death due to any cause
Measured: From first dose to event (up to study completion) , an average of 3 years
Incidence of adverse events (AEs)
Incidence of adverse events determined and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 6.0.
Measured: From baseline up to 4 weeks after last dose
Severity of AEs
All adverse medical events that occur after the subject receives the investigational drug may be manifested as symptoms, signs, disease, or laboratory abnormalities, but are not necessarily causally related to the investigational drug, evaluated according to the CTCAE v6.0.
Measured: From baseline up to 4 weeks after last dose
Urinary excretion amount (Ae0-24)
Amount of drug excreted in urine within 24 hours after single and multiple oral doses of TQ05105.
Measured: Pre-dose (-24-0 hours), 0-3, 3-6, 6-9, 9-12, 12-24 hours post-dose
Cumulative urinary excretion rate (Ae0-24%)
Percentage of the dose excreted in urine within 24 hours after single and multiple oral doses of TQ05105.
Measured: Pre-dose (-24-0 hours), 0-3, 3-6, 6-9, 9-12, 12-24 hours post-dose
Proportion of subjects receiving red blood cell transfusion within 24 weeks
Proportion of subjects who receive red blood cell transfusion during the first 24 weeks of treatment.
Measured: Up to 24 weeks
Proportion of subjects receiving platelet transfusion within 24 weeks
Proportion of subjects who receive platelet transfusion during the first 24 weeks of treatment.
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2026
- Study start18 Jun 2026
- Primary completionJun 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelofibrosisStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07551427
- Sponsor's protocol ID
- TQ05105-II-08
- Status last verified
- Feb 2026
- First submitted
- 17 Apr 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No