Status:
RECRUITING
A Clinical Trial of TQ05105 Tablets in the Treatment of Chronic Graft-versus-host Disease
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions:
Chronic Graft Versus Host Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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
Eligibility Criteria
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;
Key Trial Info
Start Date :
May 7 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT06300320
Start Date
May 7 2024
End Date
April 1 2026
Last Update
February 11 2025
Active Locations (12)
Enter a location and click search to find clinical trials sorted by distance.
1
Anhui Provincial Hospital
Hefei, Anhui, China, 230001
2
The 940th hospital of joint logistics support force of Chinese people's liberation army
Lanzhou, Gansu, China, 730050
3
Guangzhou First People's Hospital
Guangzhou, Guangdong, China, 510180
4
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530021