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NCT06300320
A Clinical Trial of TQ05105 Tablets in the Treatment of Chronic Graft-versus-host Disease
Conditions: Chronic Graft Versus Host Disease
Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 65
Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Location: Anhui Provincial Hospital Hefei Anhui
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;
Source: ClinicalTrials.gov (NCT06300320). StuddyBuddy aggregates publicly available trial information.