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

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: Chronic Graft Versus Host Disease
• Intervention / Treatment: Drug: TQ05105 tablets

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: He Huang, PhD; Phone Number: 13605714822; Email: hehuangyu@126.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230001
      • Not yet recruiting
      • Anhui Provincial Hospital
      • Contact: Lianxin Liu, PhD; Phone Number: 15255456091; Email: xiaoyuz@ustc.edu.cn
  • Gansu
    • Lanzhou, Gansu, China, 730050
      • Not yet recruiting
      • The 940th hospital of joint logistics support force of Chinese people's liberation army
      • Contact: Tao Wu, PhD; Phone Number: 13919939297; Email: wutaozhen@yeah.net
  • Guangdong
    • Guangzhou, Guangdong, China, 510180
      • Not yet recruiting
      • Guangzhou First People's Hospital
      • Contact: Shunqing Wang, PhD; Phone Number: 13437801998; Email: drwangshq@medmail.com.cn
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • Not yet recruiting
      • The First Affiliated Hospital of Guangxi Medical University
      • Contact: Zhongming Zhang, Master; Phone Number: 15807801369; Email: zzmmissyou@126.com
  • Hebei
    • Shijiazhuang, Hebei, China, 050000
      • Not yet recruiting
      • The Second Hospital of Hebei Medical University
      • Contact: Xuejun Zhang, PhD; Phone Number: 13722781112; Email: zhxjhbmu@126.com
  • Hubei
    • Xiangyang, Hubei, China, 441021
      • Not yet recruiting
      • Xiangyang Central Hospital
      • Contact: Guolin Yuan, PhD; Phone Number: 18696231603; Email: yuanguo1973@163.com
  • Shangdong
    • Taian, Shangdong, China
      • Not yet recruiting
      • Tai'an Central Hospital
      • Contact: Guanchen Bai, Bachelor; Phone Number: 18653819776; Email: bgcbgc1@163.com
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Not yet recruiting
      • Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine
      • Contact: Xiaoxia Hu, PhD; Phone Number: 13795437259; Email: hu_xiaoxia@126.com
  • Shannxi
    • Xian, Shannxi, China, 710299
      • Not yet recruiting
      • The Second Affiliated Hospital of Xi'an Jiaotong University
      • Contact: Aili He, PhD; Phone Number: 13891939962; Email: heaili@xiju.edu.cn
  • Tianjin
    • Tianjin, Tianjin, China, 300020
      • Not yet recruiting
      • Hematology Hospital of the Chinese Academy of Medical Sciences
      • Contact: Er lie Jiang, PhD; Phone Number: 022-23909180; Email: jiangerlie@ihcams.ac.cn
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Recruiting
      • The first Affiliated Hospital, Zhejiang University School of Medicine
      • Contact: He Huang, PhD; Phone Number: 13605714822; Email: hehuangyu@126.com
    • Ningbo, Zhejiang, China, 315040
      • Not yet recruiting
      • The Affiliated People's Hospital of Ningbo University
      • Contact: Ying Lu, Master; Phone Number: 13486090834; Email: rmluying@nbu.edu.cn

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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	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
Best objective response rate (BOR)	Proportion of subjects achieving CR+PR and at any time point prior to initiation of other systemic therapies for cGVHD	Up to 48 weeks
Duration of response (DOR)	Time to first response to cGVHD disease progression, death, or initiation of any new systemic therapy for cGVHD	Up to 48 weeks
Failure-free survival (FFS)	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 48 weeks
Incidence rate of malignancy relapse or recurrence	Proportion of subjects with recurrence date of blood system disease from the first dose	Up to 48 weeks
Non relapse mortality	From first dose to the date of death, with no recurrence of the original disease	At least 48 weeks
Overall Survival (OS)	Time from first dose to death caused by various reasons	At least 48 weeks
Adverse event rate	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 48 weeks
Severity of adverse events (AEs)	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

Collaborators and Investigators

• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2024
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): April 1, 2026

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): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 9, 2025
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organizing Pneumonia; Immune System Diseases; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchiolitis Obliterans Syndrome; Graft vs Host Disease
• 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