Approximately 30 subjects will be enrolled to receive orally administered BN101 200 mg QD (once daily)~Study drug will be administered in 28-day cycles until disease progression or unacceptable toxicity. Subjects may receive study drug in the inpatient or outpatient setting.~Curative Effect analysis The efficacy was analyzed based on MITT The point estimate and 95%CI of ORR were calculated based on the exact probability method of binomial distribution.If applicable, a logistic regression model will be used for multivariate analysis.~Descriptive statistical analyses were provided for all secondary efficacy endpoints.~The following subgroups will be analysed:~Severe cGVHD (Yes/No)~Number of organs involved (<4 vs. ≥4)~Number of previous systemic cGVHD treatment (1 vs. ≥2)~Duration of cGVHD before inclusion (i.e., from the time of cGVHD diagnosis to the time of inclusion)~Lung Involvement (Yes/No)
This is a phase 2, open-label, multicenter trial to evaluate the efficacy and safety of BN101 in subjects with Chronic Graft Versus Host Disease (cGVHD) after at least First Line of systemic therapy.