A Clinical Trial of TQ05105 Tablets in the Treatment of Chronic Graft-versus-host Disease
- Conditions
- Chronic Graft Versus Host Disease
- Interventions
- Drug: TQ05105 tablets
- Registration Number
- NCT06300320
- Lead Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 52
- 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
- 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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TQ05105 Tablets TQ05105 tablets TQ05105 Tablets administered twice-daily. 28 days as a treatment cycle.
- Primary Outcome Measures
Name Time Method 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).
- Secondary Outcome Measures
Name Time Method Incidence rate of malignancy relapse or recurrence Up to 48 weeks Proportion of subjects with recurrence date of blood system disease from the first dose
Overall Survival (OS) At least 48 weeks Time from first dose to death caused by various reasons
Non relapse mortality At least 48 weeks From first dose to the date of death, with no recurrence of the original disease
Best objective response rate (BOR) Up to 48 weeks Proportion of subjects achieving CR+PR and at any time point prior to initiation of other systemic therapies for cGVHD
Duration of response (DOR) Up to 48 weeks Time to first response to cGVHD disease progression, death, or initiation of any new systemic therapy for cGVHD
Severity of adverse events (AEs) Up to 48 weeks Severity of all adverse medical events that occur after the subject receives the investigational drug, evaluated according to the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
Failure-free survival (FFS) Up to 48 weeks The time from the first dose to the time of recurrence, death, or death or increase in non-original disease or initiation of a new cGVHD systemic
Adverse event rate Up to 48 weeks The occurrence of all adverse events (AEs), serious adverse events (SAEs) , evaluated according to the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
Trial Locations
- Locations (12)
Anhui Provincial Hospital
🇨🇳Hefei, Anhui, China
Guangzhou First People's Hospital
🇨🇳Guangzhou, Guangdong, China
The Affiliated People's Hospital of Ningbo University
🇨🇳Ningbo, Zhejiang, China
The Second Hospital of Hebei Medical University
🇨🇳Shijiazhuang, Hebei, China
Tai'an Central Hospital
🇨🇳Taian, Shangdong, China
Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine
🇨🇳Shanghai, Shanghai, China
The First Affiliated Hospital, Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China
Xiangyang Central Hospital
🇨🇳Xiangyang, Hubei, China
The Second Affiliated Hospital of Xi'an Jiaotong University
🇨🇳Xian, Shannxi, China
The 940th hospital of joint logistics support force of Chinese people's liberation army
🇨🇳Lanzhou, Gansu, China
The First Affiliated Hospital of Guangxi Medical University
🇨🇳Nanning, Guangxi, China
Hematology Hospital of the Chinese Academy of Medical Sciences
🇨🇳Tianjin, Tianjin, China