Chronic Graft Versus Host DiseasePhase 2NCT06300320
A Clinical Trial of TQ05105 Tablets in the Treatment of Chronic Graft-versus-host Disease
A Phase 2 study testing TQ05105 tablets in people with Chronic Graft Versus Host Disease, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 12 sites in China.
Trial summary
This is an open, multi-center clinical study designed to evaluate the efficacy and safety of TQ05105 Tablets in patients with chronic graft-versus-host disease Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Graft Versus Host Disease
- What is being tested?
- TQ05105 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 12 sitesChina
- Study dates
- 7 May 2024to May 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary and signed informed consent, good compliance;
- Age 18-70 years old; Karnofsky Performance Scale (KPS) ≥60 points; Life expectancy ≥ 6months.
- Received allogeneic hematopoietic stem cell transplantation;
- Diagnosis of moderate-to-severe chronic graft-versus-host disease (cGVHD)
- Received systemic therapies for cGVHD;
- Stable dose of glucocorticoids, other immunosuppressant therapy received within 2 weeks prior to screening;
- Absolute Neutrophil Count (ANC) ≥ 1.0×10 9/L ；platelet count (PLT) ≥30×10 9 /L; Hemoglobin ≥80g/L; There were no obvious abnormalities in liver and kidney function and coagulation function;
- Men and women of childbearing age agree to use contraceptive measures during the study period and within 6 months after the end of the study
Who cannot join
- Currently present or occured other malignancies within 3 years prior to first administration;
- Known or suspected active acute graft versus host disease (aGVHD);
- Presence of infection requiring treatment within 7 days prior to randomization;
- Failed allogeneic hematopoietic stem cell transplantation within 6 months or 2 prior allogeneic hematopoietic stem cell transplants;
- Use of Janus-activated kinase (JAK) inhibitors, Bruton's tyrosine kinase (BTK) inhibitors, or other, chemotherapeutic agents within 2 weeks prior to randomization;
- Has a variety of factors that affect oral medications (e.g., inability to swallow, , intestinal obstruction, etc;
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- Those who have a history of psychotropic drug abuse and cannot be abstained from or have a mental disorder;
- Have any severe or uncontrolled serious illness, including but not limited to uncontrolled hypertension, heart disease, hepatitis and epilepsy that require treatment;
- Have any severe or uncontrolled serious illness, including but not limited to，uncontrolled hypertension heart disease, hepatitis and epilepsy that require treatment;
- Those who are allergic to the study drug or its components;
- Participation in other clinical trials or major surgery within 4 weeks prior to the first dose;
- Subjects judged by the investigator to be unsuitable for enrollment;
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
China12 sites, 12 recruiting
- Not yet recruiting
Guangzhou First People's Hospital
Guangzhou, Guangdong, 510180
Shunqing Wang, PhD, 13437801998, drwangshq@medmail.com.cn
- Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000
He Huang, PhD, 13605714822, hehuangyu@126.com
- Not yet recruiting
Anhui Provincial Hospital
Hefei, Anhui, 230001
Lianxin Liu, PhD, 15255456091, xiaoyuz@ustc.edu.cn
- Not yet recruiting
The 940th hospital of joint logistics support force of Chinese people's liberation army
Lanzhou, Gansu, 730050
Tao Wu, PhD, 13919939297, wutaozhen@yeah.net
- Not yet recruiting
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021
Zhongming Zhang, Master, 15807801369, zzmmissyou@126.com
- Not yet recruiting
The Affiliated People's Hospital of Ningbo University
Ningbo, Zhejiang, 315040
Ying Lu, Master, 13486090834, rmluying@nbu.edu.cn
- Not yet recruiting
Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Xiaoxia Hu, PhD, 13795437259, hu_xiaoxia@126.com
- Not yet recruiting
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
Xuejun Zhang, PhD, 13722781112, zhxjhbmu@126.com
- Not yet recruiting
Tai'an Central Hospital
Taian, Shangdong
Guanchen Bai, Bachelor, 18653819776, bgcbgc1@163.com
- Not yet recruiting
Hematology Hospital of the Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300020
Er lie Jiang, PhD, 022-23909180, jiangerlie@ihcams.ac.cn
- Not yet recruiting
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shannxi, 710299
Aili He, PhD, 13891939962, heaili@xiju.edu.cn
- Not yet recruiting
Xiangyang Central Hospital
Xiangyang, Hubei, 441021
Guolin Yuan, PhD, 18696231603, yuanguo1973@163.com
About this study
Official title: A Randomized, Open-label, Multicenter Phase II Clinical Trial of Rovadicitinib in the Treatment of Third-line and Subsequent Moderate to Severe Chronic Graft-versus-host Disease (cGVHD).
This is an open, multi-center clinical study designed to evaluate the efficacy and safety of TQ05105 Tablets in patients with chronic graft-versus-host disease
- Conditions
- Chronic Graft Versus Host Disease
- Being tested
- TQ05105 tablets
- Medical subject headings
- Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQ05105 tabletsDrug
Rovadicitinib (TQ05105) is a novel, oral dual JAK 1/2 and Rho-associated kinases (ROCK) 1/2 inhibitor targeting inflammatory and fibrotic components of cGVHD.
| Study group | Role | What they receive |
|---|---|---|
| TQ05105 Tablets | Experimental | TQ05105 Tablets administered twice-daily. 28 days as a treatment cycle. Receives: Drug: TQ05105 tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR) at 24 weeks
Percentage of subjects with an overall response of all evaluable organs as complete response (CR) or partial response (PR).
Measured: Up to 24 weeks
Secondary outcomes (8)
Best objective response rate (BOR)
Proportion of subjects achieving CR+PR and at any time point prior to initiation of other systemic therapies for cGVHD
Measured: Up to 96 weeks
Duration of response (DOR)
Time to first response to cGVHD disease progression, death, or initiation of any new systemic therapy for cGVHD
Measured: Up to 96 weeks
Failure-free survival (FFS)
The time from the first dose to the time of recurrence, death, or death or increase in non-original disease or initiation of a new cGVHD systemic
Measured: Up to 96 weeks
Incidence rate of malignancy relapse or recurrence
Proportion of subjects with recurrence date of blood system disease from the first dose
Measured: Up to 96 weeks
Non relapse mortality
From first dose to the date of death, with no recurrence of the original disease
Measured: At least 96 weeks
Overall Survival (OS)
Time from first dose to death caused by various reasons
Measured: At least 96 weeks
Adverse event rate
The occurrence of all adverse events (AEs), serious adverse events (SAEs) , evaluated according to the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
Measured: Up to 96 weeks
Severity of adverse events (AEs)
Severity of all adverse medical events that occur after the subject receives the investigational drug, evaluated according to the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
Measured: Up to 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start7 May 2024
- Primary completionNov 2027 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Graft Versus Host DiseaseStudies 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
- 65 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
- NCT06300320
- Sponsor's protocol ID
- TQ05105-II-06
- Status last verified
- Jun 2026
- First submitted
- 4 Mar 2024
- Last updated
- 26 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No