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).
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
52 participants
May 7, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- 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 Criteria12
- 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;
Interested in this trial?
Get notified about updates and connect with the research team.
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.
Locations(12)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06300320