A Clinical Trial of TQ05105 Tablets in the Treatment of Chronic Graft-versus-host Disease
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).
1 other identifier
interventional
52
1 country
12
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2024
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2024
CompletedFirst Posted
Study publicly available on registry
March 8, 2024
CompletedStudy Start
First participant enrolled
May 7, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2026
CompletedFebruary 11, 2025
November 1, 2024
1.4 years
March 4, 2024
February 9, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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).
Up to 24 weeks
Secondary Outcomes (8)
Best objective response rate (BOR)
Up to 48 weeks
Duration of response (DOR)
Up to 48 weeks
Failure-free survival (FFS)
Up to 48 weeks
Incidence rate of malignancy relapse or recurrence
Up to 48 weeks
Non relapse mortality
At least 48 weeks
- +3 more secondary outcomes
Study Arms (1)
TQ05105 Tablets
EXPERIMENTALTQ05105 Tablets administered twice-daily. 28 days as a treatment cycle.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Anhui Provincial Hospital
Hefei, Anhui, 230001, China
The 940th hospital of joint logistics support force of Chinese people's liberation army
Lanzhou, Gansu, 730050, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, 510180, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000, China
Xiangyang Central Hospital
Xiangyang, Hubei, 441021, China
Tai'an Central Hospital
Taian, Shangdong, China
Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025, China
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shannxi, 710299, China
Hematology Hospital of the Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300020, China
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310000, China
The Affiliated People's Hospital of Ningbo University
Ningbo, Zhejiang, 315040, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2024
First Posted
March 8, 2024
Study Start
May 7, 2024
Primary Completion
October 1, 2025
Study Completion
April 1, 2026
Last Updated
February 11, 2025
Record last verified: 2024-11