NCT04944043

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

A Single Group, Open-Label, Multicenter ,Phase Ib/II Clinical Trials of TQ05105 Tablet in Patients With Glucocorticoid Refractory and Dependent Moderate to Severe Chronic Graft Versus Host Disease (cGVHD).

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Chronic Graft Versus Host Disease

Interventions

Type	Name	Description
DRUG	TQ05105 Tablet	TQ05105 tablet is a Janus Kinase (JAK) inhibitor, which can inhibit the abnormal activation of JAK 2-V617F mutation, thereby inhibiting the sustained abnormal activation of JAK / STAT pathway.

Timeline

• Start date: 2021-06-25
• Primary completion: 2023-06-30
• Completion: 2026-12-31
• First posted: 2021-06-29
• Last updated: 2025-12-03

Locations

12 sites across 1 country: China