A Clinical Trial of TQ05105 Tablets in the Treatment of Chronic Graft-versus-host Disease

Launched by CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD. · Mar 4, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called TQ05105 tablets to see how well it works and how safe it is for people with chronic graft-versus-host disease (cGVHD). cGVHD can occur after a stem cell transplant when the donated immune cells attack the patient’s own body. The trial is currently looking for participants between the ages of 18 and 70 who have moderate to severe cGVHD and have already received other treatments for this condition.

To join the trial, participants need to be in generally good health, have a life expectancy of at least six months, and not have any serious medical issues that could interfere with the study. They will need to agree to use birth control if they are of childbearing age. People who are interested can expect to receive the study medication and be monitored closely by medical staff throughout the trial. This is an important opportunity to contribute to research that may help improve treatments for cGVHD in the future.

Gender

ALL

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;