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Clinical Trials in China / NCT06300320
Recruiting Phase 2

A Clinical Trial of TQ05105 Tablets in the Treatment of Chronic Graft-versus-host Disease

NCT06300320 · tracked via the Priya Life Science China tracker
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Phase
Phase 2
Started
2024-05-07
Last updated
2026-08-26

Condition(s) studied

Chronic Graft Versus Host Disease

Investigational drug(s) / intervention(s)

TQ05105 tablets →

TQ05105 tablets: 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 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

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * 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; * 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;

Primary outcome measure(s)

Trial sites (12)

FacilityCityRegionStatus
Anhui Provincial Hospital Hefei Anhui Not Yet Recruiting
The 940th hospital of joint logistics support force of Chinese people's liberation army Lanzhou Gansu Not Yet Recruiting
Guangzhou First People's Hospital Guangzhou Guangdong Not Yet Recruiting
The First Affiliated Hospital of Guangxi Medical University Nanning Guangxi Not Yet Recruiting
The Second Hospital of Hebei Medical University Shijiazhuang Hebei Not Yet Recruiting
Xiangyang Central Hospital Xiangyang Hubei Not Yet Recruiting
Tai'an Central Hospital Taian Shangdong Not Yet Recruiting
Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine Shanghai Shanghai Municipality Not Yet Recruiting
The Second Affiliated Hospital of Xi'an Jiaotong University Xi'an Shannxi Not Yet Recruiting
Hematology Hospital of the Chinese Academy of Medical Sciences Tianjin Tianjin Municipality Not Yet Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang Recruiting
The Affiliated People's Hospital of Ningbo University Ningbo Zhejiang Not Yet Recruiting

More Chia Tai Tianqing Pharmaceutical Group Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06300320 on ClinicalTrials.gov ↗ ← All trials in China