A Study of TQ05105 in Patients With Chronic Graft Versus Host Disease

CTTQ

Status and phase

Active, not recruiting

Phase 2

Phase 1

Conditions

Chronic Graft Versus Host Disease

Treatments

Drug: TQ05105 Tablet

Study type

Interventional

Funder types

Industry

Identifiers

NCT04944043

TQ05105-Ib/II-02

Details and patient eligibility

About

This study was a single arm, open label, multicenter phase Ib / II trial in subjects with glucocorticoid refractory / dependent moderate to severe cGVHD.The trial consisted of two phases: phase I for the dose exploration and phase II for the extension study.

Enrollment

45 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Understood and signed an informed consent form.
≥18 years old, Karnofsky Performance Scale of ≥60, life expectancy ≥ 6 months.
Has received allogeneic hematopoietic stem cell transplantation (alloSCT).
Clinically diagnosed moderate to severe cGVHD according to NIH Consensus Criteria.
Has received systemic or topical corticosteroids therapy and confirmed steroid-refractory/dependent cGVHD according to NIH Consensus Criteria.
Has received at least 1 lines of therapy for cGVHD.
Adequate laboratory indicators.
No pregnant or breastfeeding women, and a negative pregnancy test.

Exclusion criteria

Has active acute GVHD.
Has previously failed to respond to JAK inhibitors for GVHD, or who had used JAK inhibitors within 4 weeks before the first administration.
Has uncontrollable active infections or infections requiring systematic treatment within 7 days before the first administration.
Development of other basic diseases.
Has malignant tumors within 3 years.
Has multiple factors affecting oral medication.
Has substance abuse or a psychotic disorder.
Has severe and / or uncontrolled disease.
Allergic to drugs or its constituents.
Has participated in any other clinical trials within 4 weeks before first administration.
According to the judgement of the investigators, there are other factors that may lead to the termination of the study.