Actively Recruiting
A Clinical Trial of TQ05105 Tablets in the Treatment of Chronic Graft-versus-host Disease
Led by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Updated on 2025-02-11
52
Participants Needed
12
Research Sites
99 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Clinical Trial of TQ05105 Tablets in the Treatment of Chronic Graft-versus-host Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary and signed informed consent, good compliance
- Aged 18 to 70 years old
- Karnofsky Performance Scale (KPS) 60 points or higher
- Life expectancy of at least 6 months
- Received allogeneic hematopoietic stem cell transplantation
- Diagnosed with moderate-to-severe chronic graft-versus-host disease (cGVHD)
- Received systemic therapies for cGVHD
- Stable dose of glucocorticoids or other immunosuppressant therapy within 2 weeks prior to screening
- Absolute Neutrophil Count (ANC) of at least 1.0 x 10^9/L
- Platelet count (PLT) of at least 30 x 10^9/L
- Hemoglobin level of at least 80 g/L
- No obvious abnormalities in liver, kidney, or coagulation function
- Men and women of childbearing potential agree to use contraception during the study and for 6 months after
You will not qualify if you...
- Current or past other malignancies within 3 years prior to first administration
- Known or suspected active acute graft-versus-host disease (aGVHD)
- Infection requiring treatment within 7 days prior to randomization
- Failed allogeneic hematopoietic stem cell transplantation within 6 months or had 2 prior allogeneic transplants
- Use of JAK inhibitors, BTK inhibitors, or chemotherapy within 2 weeks prior to randomization
- Conditions affecting oral medication intake (e.g., inability to swallow, intestinal obstruction)
- History of psychotropic drug abuse or mental disorder preventing abstinence
- Severe or uncontrolled serious illnesses including uncontrolled hypertension, heart disease, hepatitis, or epilepsy requiring treatment
- Allergy to the study drug or its components
- Participation in other clinical trials or major surgery within 4 weeks prior to first dose
- Judged unsuitable for enrollment by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 12 locations
1
Anhui Provincial Hospital
Hefei, Anhui, China, 230001
Not Yet Recruiting
2
The 940th hospital of joint logistics support force of Chinese people's liberation army
Lanzhou, Gansu, China, 730050
Not Yet Recruiting
3
Guangzhou First People's Hospital
Guangzhou, Guangdong, China, 510180
Not Yet Recruiting
4
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530021
Not Yet Recruiting
5
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050000
Not Yet Recruiting
6
Xiangyang Central Hospital
Xiangyang, Hubei, China, 441021
Not Yet Recruiting
7
Tai'an Central Hospital
Taian, Shangdong, China
Not Yet Recruiting
8
Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China, 200025
Not Yet Recruiting
9
The Second Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shannxi, China, 710299
Not Yet Recruiting
10
Hematology Hospital of the Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China, 300020
Not Yet Recruiting
11
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
12
The Affiliated People's Hospital of Ningbo University
Ningbo, Zhejiang, China, 315040
Not Yet Recruiting
Research Team
H
He Huang, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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