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

CTTQ

Status and phase

Enrolling

Phase 2

Conditions

Chronic Graft Versus Host Disease

Treatments

Drug: TQ05105 tablets

Study type

Interventional

Funder types

Industry

Identifiers

NCT06300320

TQ05105-II-06

Details and patient eligibility

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

Enrollment

52 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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;