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NCT04944043Active, not recruitingPhase 1/2

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).

Source: ClinicalTrials.gov · Last updated 3 Dec 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
45 (actual)
First submitted
21 Jun 2021
Start date
25 Jun 2021
Primary completion date
30 Jun 2023
Lead sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
NCT number
NCT04944043

What you commit to

  • Study type: Interventional · Phase 1/2
  • Participants enrolled: 45
  • From 25 Jun 2021 to the primary completion date, 30 Jun 2023
  • 12 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.
  • Has multiple factors affecting oral medication.
  • Has participated in any other clinical trials within 4 weeks before first administration.

Other illness

  • Development of other basic diseases.
  • Has malignant tumors within 3 years.
  • Has substance abuse or a psychotic disorder.
  • Has severe and / or uncontrolled disease.
  • Allergic to drugs or its constituents.

Other

  • Has active acute GVHD.
  • According to the judgement of the investigators, there are other factors that may lead to the termination of the study.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (12)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Nanfang Hospital of Southern Medical University
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GuangzhouChinaUnknown status
Guangzhou First People's Hospital
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GuangzhouChinaUnknown status
Zhujiang Hospital of Southern Medical University
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GuangzhouChinaUnknown status
The First Affiliated Hospital, Zhejiang University School of Medicine
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HanzhouChinaUnknown status
The First Affiliated Hospital of USTC(Anhui Provincial Hospital)
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HefeiChinaUnknown status
The First Affiliated Hospital of Guangxi Medical University
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NanningChinaUnknown status
The Second Hospital of Hebei Medical University
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ShijiazhuangChinaUnknown status
The First Affiliated Hospital of Soochow University
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SuzhouChinaUnknown status
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
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TianjinChinaUnknown status
Tongji Hospital Tongji Medical College of Hust
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WuhanChinaUnknown status
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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WuhanChinaUnknown status
The First Affiliated Hospital of Zhengzhou University
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ZhengzhouChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.