研究单位:[1]Chia Tai Tianqing Pharmaceutical Group Co., Ltd.[2]The First Affiliated Hospital of USTC (Anhui Provincial Hospital),Hefei,Anhui,China,230001[3]Zhujiang Hospital of Southern Medical University,Guangzhou,Guangdong,China,510280[4]Nanfang Hospital of Southern Medical University,Guangzhou,Guangdong,China,510515[5]Guangzhou First People's Hospital,Guangzhou,Guangdong,China,511457[6]The First Affiliated Hospital of Guangxi Medical University,Nanning,Guangxi,China,530021[7]The Second Hospital of Hebei Medical University,Shijiazhuang,Hebei,China,050000[8]The First Affiliated Hospital of Zhengzhou University,Zhengzhou,Henan,China,450052[9]Union Hospital Tongji Medical College Huazhong University of Science and Technology,Wuhan,Hubei,China,430022[10]Tongji Hospital Tongji Medical College of HUST,Wuhan,Hubei,China,430030[11]The First Affiliated Hospital of Soochow University,Suzhou,Jiangsu,China,215006[12]Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College,Tianjin,Tianjin,China,300020[13]The First Affiliated Hospital, Zhejiang University School of Medicine,Hanzhou,Zhejiang,China,310000
研究目的:
This study was a single arm, open label, multicenter phase Ib / II trial in subjects with glucocorticoid refractory / dependent moderate to severe cGVHD.The trial consisted of two phases: phase I for the dose exploration and phase II for the extension study.