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
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)
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;
Single group
TQ05105 tablets
DrugRovadicitinib (TQ05105) is a novel, oral dual JAK 1/2 and Rho-associated kinases (ROCK) 1/2 inhibitor targeting inflammatory and fibrotic components of cGVHD.
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).
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
Duration of response (DOR)
Time to first response to cGVHD disease progression, death, or initiation of any new systemic therapy for cGVHD
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
Incidence rate of malignancy relapse or recurrence
Proportion of subjects with recurrence date of blood system disease from the first dose
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