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

August 24, 2026 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

A Randomized, Open-label, Multicenter Phase II Clinical Trial of Rovadicitinib in the Treatment of Third-line and Subsequent Moderate to Severe Chronic Graft-versus-host Disease (cGVHD).

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

65

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China, 230001
        • Not yet recruiting
        • Anhui Provincial Hospital
        • Contact:
    • Gansu
      • Lanzhou, Gansu, China, 730050
        • Not yet recruiting
        • The 940th hospital of joint logistics support force of Chinese people's liberation army
        • Contact:
    • Guangdong
      • Guangzhou, Guangdong, China, 510180
        • Not yet recruiting
        • Guangzhou First People's Hospital
        • Contact:
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Not yet recruiting
        • The first affiliated hospital of Guangxi Medical University
        • Contact:
    • Hebei
      • Shijiazhuang, Hebei, China, 050000
        • Not yet recruiting
        • The Second Hospital of Hebei Medical University
        • Contact:
    • Hubei
      • Xiangyang, Hubei, China, 441021
        • Not yet recruiting
        • Xiangyang Central Hospital
        • Contact:
    • Shangdong
      • Taian, Shangdong, China
        • Not yet recruiting
        • Tai'an Central Hospital
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200025
        • Not yet recruiting
        • Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
        • Contact:
    • Shannxi
      • Xi'an, Shannxi, China, 710299
        • Not yet recruiting
        • The Second Affiliated Hospital of Xi'An Jiaotong University
        • Contact:
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300020
        • Not yet recruiting
        • Hematology Hospital of the Chinese Academy of Medical Sciences
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • The First Affiliated Hospital, Zhejiang University School of Medicine
        • Contact:
      • Ningbo, Zhejiang, China, 315040
        • Not yet recruiting
        • The affiliated people's hospital of ningbo university
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TQ05105 Tablets
TQ05105 Tablets administered twice-daily. 28 days as a treatment cycle.
Drug: TQ05105 tablets
Rovadicitinib (TQ05105) is a novel, oral dual JAK 1/2 and Rho-associated kinases (ROCK) 1/2 inhibitor targeting inflammatory and fibrotic components of cGVHD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR) at 24 weeks
Time Frame: Up to 24 weeks
Percentage of subjects with an overall response of all evaluable organs as complete response (CR) or partial response (PR).
Up to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of adverse events (AEs)
Time Frame: Up to 48 weeks
Severity of all adverse medical events that occur after the subject receives the investigational drug, evaluated according to the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
Up to 48 weeks
Best objective response rate (BOR)
Time Frame: Up to 96 weeks
Proportion of subjects achieving CR+PR and at any time point prior to initiation of other systemic therapies for cGVHD
Up to 96 weeks
Duration of response (DOR)
Time Frame: Up to 96 weeks
Time to first response to cGVHD disease progression, death, or initiation of any new systemic therapy for cGVHD
Up to 96 weeks
Failure-free survival (FFS)
Time Frame: Up to 96 weeks
The time from the first dose to the time of recurrence, death, or death or increase in non-original disease or initiation of a new cGVHD systemic
Up to 96 weeks
Incidence rate of malignancy relapse or recurrence
Time Frame: Up to 96 weeks
Proportion of subjects with recurrence date of blood system disease from the first dose
Up to 96 weeks
Non relapse mortality
Time Frame: At least 96 weeks
From first dose to the date of death, with no recurrence of the original disease
At least 96 weeks
Overall Survival (OS)
Time Frame: At least 96 weeks
Time from first dose to death caused by various reasons
At least 96 weeks
Adverse event rate
Time Frame: Up to 96 weeks
The occurrence of all adverse events (AEs), serious adverse events (SAEs) , evaluated according to the Common Terminology Criteria for Adverse Events Version 5.0 (CTCAE v5.0)
Up to 96 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2024

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

May 1, 2029

Study Registration Dates

First Submitted

March 4, 2024

First Submitted That Met QC Criteria

March 4, 2024

First Posted (Actual)

March 8, 2024

Study Record Updates

Last Update Posted (Actual)

August 26, 2026

Last Update Submitted That Met QC Criteria

August 24, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TQ05105-II-06

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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