Chronic Graft Versus Host Disease
Conditions
Brief 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
Interventions
DRUGTQ05105 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.
Sponsors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) at 24 weeks | Up to 24 weeks | Percentage of subjects with an overall response of all evaluable organs as complete response (CR) or partial response (PR). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of response (DOR) | Up to 48 weeks | Time to first response to cGVHD disease progression, death, or initiation of any new systemic therapy for cGVHD |
| Failure-free survival (FFS) | Up to 48 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 |
| Incidence rate of malignancy relapse or recurrence | Up to 48 weeks | Proportion of subjects with recurrence date of blood system disease from the first dose |
| Best objective response rate (BOR) | Up to 48 weeks | Proportion of subjects achieving CR+PR and at any time point prior to initiation of other systemic therapies for cGVHD |
| Overall Survival (OS) | At least 48 weeks | Time from first dose to death caused by various reasons |
| Adverse event rate | Up to 48 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) |
| Severity of adverse events (AEs) | 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) |
| Non relapse mortality | At least 48 weeks | From first dose to the date of death, with no recurrence of the original disease |
Countries
China
Contacts
Primary ContactHe Huang, PhD
Outcome results
None listed