🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT04944043
Active, not recruiting Phase 1/2

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

NCT04944043 · tracked via the Priya Life Science China tracker
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Phase
Phase 1/2
Started
2021-06-25
Last updated
2025-12-03

Condition(s) studied

Chronic Graft Versus Host Disease

Investigational drug(s) / intervention(s)

TQ05105 Tablet →

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (12)

FacilityCityRegionStatus
The First Affiliated Hospital of USTC (Anhui Provincial Hospital) Hefei Anhui
Zhujiang Hospital of Southern Medical University Guangzhou Guangdong
Nanfang Hospital of Southern Medical University Guangzhou Guangdong
Guangzhou First People's Hospital Guangzhou Guangdong
The First Affiliated Hospital of Guangxi Medical University Nanning Guangxi
The Second Hospital of Hebei Medical University Shijiazhuang Hebei
The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan
Union Hospital Tongji Medical College Huazhong University of Science and Technology Wuhan Hubei
Tongji Hospital Tongji Medical College of HUST Wuhan Hubei
The First Affiliated Hospital of Soochow University Suzhou Jiangsu
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College Tianjin Tianjin Municipality
The First Affiliated Hospital, Zhejiang University School of Medicine Hanzhou Zhejiang

More Chia Tai Tianqing Pharmaceutical Group Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04944043 on ClinicalTrials.gov ↗ ← All trials in China