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

Chronic Graft Versus Host Disease Clinical Trial

Official title:

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).

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06300320
• Other study ID #: TQ05105-II-06
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: April 2024
• Est. completion date: April 2026

Study information

• Verified date: March 2024
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: He Huang, PhD
• Phone: 13605714822
• Email: hehuangyu[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: April 2026
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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, chronic diarrhea, 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;

Related Conditions & MeSH terms

• Bronchiolitis Obliterans Syndrome
• Chronic Graft Versus Host Disease
• Graft vs Host Disease

Intervention

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.

Locations

Country	Name	City	State
China	Guangzhou First People's Hospital	Guangzhou	Guangdong
China	The First Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Anhui Provincial Hospital	Hefei	Anhui
China	The 940th hospital of joint logistics support force of Chinese people's liberation army	Lanzhou	Gansu
China	The First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi
China	The Affiliated People's Hospital of Ningbo University	Ningbo	Zhejiang
China	Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	The Second Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	Tai'an Central Hospital	Taian	Shangdong
China	Hematology Hospital of the Chinese Academy of Medical Sciences	Tianjin	Tianjin
China	The Second Affiliated Hospital of Xi'an Jiaotong University	Xian	Shannxi
China	Xiangyang Central Hospital	Xiangyang	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Non relapse mortality	From first dose to the date of death, with no recurrence of the original disease	At least 48 weeks
Secondary	Overall Survival (OS)	Time from first dose to death caused by various reasons	At least 48 weeks
Secondary	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
Secondary	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