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)
Objective response rate (ORR) at 24 weeks — Up to 24 weeks Percentage of subjects with an overall response of all evaluable organs as complete response (CR) or partial response (PR).
Trial sites (12)
Facility
City
Region
Status
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
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.
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