protocolSection identificationModule nctId: NCT06300320, orgStudyIdInfo id: TQ05105-II-06, briefTitle: A Clinical Trial of TQ05105 Tablets in the Treatment of Chronic Graft-versus-host Disease, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2025-10, completionDateStruct date: 2026-04, studyFirstPostDateStruct date: 2024-03-08, lastUpdatePostDateStruct date: 2024-03-08, sponsorCollaboratorsModule leadSponsor name: Chia Tai Tianqing Pharmaceutical Group Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: 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, conditionsModule conditions: Chronic Graft Versus Host Disease, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: TQ05105 tablets, outcomesModule primaryOutcomes measure: Objective response rate (ORR) at 24 weeks, secondaryOutcomes measure: Best objective response rate (BOR), secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: Failure-free survival (FFS), secondaryOutcomes measure: Incidence rate of malignancy relapse or recurrence, secondaryOutcomes measure: Non relapse mortality, secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Adverse event rate, secondaryOutcomes measure: Severity of adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Anhui Provincial Hospital, city: Hefei, state: Anhui, zip: 230001, country: China, contacts name: Lianxin Liu, PhD, role: CONTACT, phone: 15255456091, email: xiaoyuz@ustc.edu.cn, geoPoint lat: 31.86389, lon: 117.28083, locations facility: The 940th hospital of joint logistics support force of Chinese people's liberation army, city: Lanzhou, state: Gansu, zip: 730050, country: China, contacts name: Tao Wu, PhD, role: CONTACT, phone: 13919939297, email: wutaozhen@yeah.net, geoPoint lat: 36.05701, lon: 103.83987, locations facility: Guangzhou First People's Hospital, city: Guangzhou, state: Guangdong, zip: 510180, country: China, contacts name: Shunqing Wang, PhD, role: CONTACT, phone: 13437801998, email: drwangshq@medmail.com.cn, geoPoint lat: 23.11667, lon: 113.25, locations facility: The First Affiliated Hospital of Guangxi Medical University, city: Nanning, state: Guangxi, zip: 530021, country: China, contacts name: Zhongming Zhang, Master, role: CONTACT, phone: 15807801369, email: zzmmissyou@126.com, geoPoint lat: 22.81667, lon: 108.31667, locations facility: The Second Hospital of Hebei Medical University, city: Shijiazhuang, state: Hebei, zip: 050000, country: China, contacts name: Xuejun Zhang, PhD, role: CONTACT, phone: 13722781112, email: zhxjhbmu@126.com, geoPoint lat: 38.04139, lon: 114.47861, locations facility: Xiangyang Central Hospital, city: Xiangyang, state: Hubei, zip: 441021, country: China, contacts name: Guolin Yuan, PhD, role: CONTACT, phone: 18696231603, email: yuanguo1973@163.com, geoPoint lat: 32.0422, lon: 112.14479, locations facility: Tai'an Central Hospital, city: Taian, state: Shangdong, country: China, contacts name: Guanchen Bai, Bachelor, role: CONTACT, phone: 18653819776, email: bgcbgc1@163.com, geoPoint lat: 36.18528, lon: 117.12, locations facility: Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine, city: Shanghai, state: Shanghai, zip: 200025, country: China, contacts name: Xiaoxia Hu, PhD, role: CONTACT, phone: 13795437259, email: hu_xiaoxia@126.com, geoPoint lat: 31.22222, lon: 121.45806, locations facility: The Second Affiliated Hospital of Xi'an Jiaotong University, city: Xian, state: Shannxi, zip: 710299, country: China, contacts name: Aili He, PhD, role: CONTACT, phone: 13891939962, email: heaili@xiju.edu.cn, geoPoint lat: 34.25833, lon: 108.92861, locations facility: Hematology Hospital of the Chinese Academy of Medical Sciences, city: Tianjin, state: Tianjin, zip: 300020, country: China, contacts name: Er lie Jiang, PhD, role: CONTACT, phone: 022-23909180, email: jiangerlie@ihcams.ac.cn, geoPoint lat: 39.14222, lon: 117.17667, locations facility: The First Affiliated Hospital, Zhejiang University School of Medicine, city: Hangzhou, state: Zhejiang, zip: 310000, country: China, contacts name: He Huang, PhD, role: CONTACT, phone: 13605714822, email: hehuangyu@126.com, geoPoint lat: 30.29365, lon: 120.16142, locations facility: The Affiliated People's Hospital of Ningbo University, city: Ningbo, state: Zhejiang, zip: 315040, country: China, contacts name: Ying Lu, Master, role: CONTACT, phone: 13486090834, email: rmluying@nbu.edu.cn, geoPoint lat: 29.87819, lon: 121.54945, hasResults: False