Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2025-12-26 @ 3:19 AM
Study NCT ID:
NCT06300320
Status:
RECRUITING
Last Update Posted:
2025-02-11
First Post:
2024-03-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Trial of TQ05105 Tablets in the Treatment of Chronic Graft-versus-host Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}], 'ancestors': [{'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 52}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-09', 'studyFirstSubmitDate': '2024-03-04', 'studyFirstSubmitQcDate': '2024-03-04', 'lastUpdatePostDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response rate (ORR) at 24 weeks', 'timeFrame': 'Up to 24 weeks', 'description': 'Percentage of subjects with an overall response of all evaluable organs as complete response (CR) or partial response (PR).'}], 'secondaryOutcomes': [{'measure': 'Best objective response rate (BOR)', 'timeFrame': 'Up to 48 weeks', 'description': 'Proportion of subjects achieving CR+PR and at any time point prior to initiation of other systemic therapies for cGVHD'}, {'measure': 'Duration of response (DOR)', 'timeFrame': 'Up to 48 weeks', 'description': 'Time to first response to cGVHD disease progression, death, or initiation of any new systemic therapy for cGVHD'}, {'measure': 'Failure-free survival (FFS)', 'timeFrame': 'Up to 48 weeks', 'description': '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'}, {'measure': 'Incidence rate of malignancy relapse or recurrence', 'timeFrame': 'Up to 48 weeks', 'description': 'Proportion of subjects with recurrence date of blood system disease from the first dose'}, {'measure': 'Non relapse mortality', 'timeFrame': 'At least 48 weeks', 'description': 'From first dose to the date of death, with no recurrence of the original disease'}, {'measure': 'Overall Survival (OS)', 'timeFrame': 'At least 48 weeks', 'description': 'Time from first dose to death caused by various reasons'}, {'measure': 'Adverse event rate', 'timeFrame': 'Up to 48 weeks', 'description': '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)'}, {'measure': 'Severity of adverse events (AEs)', 'timeFrame': 'Up to 48 weeks', 'description': '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)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Graft Versus Host Disease']}, '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Voluntary and signed informed consent, good compliance;\n* Age 18-70 years old; Karnofsky Performance Scale (KPS) ≥60 points; Life expectancy ≥ 6months.\n* Received allogeneic hematopoietic stem cell transplantation;\n* Diagnosis of moderate-to-severe chronic graft-versus-host disease (cGVHD)\n* Received systemic therapies for cGVHD;\n* Stable dose of glucocorticoids, other immunosuppressant therapy received within 2 weeks prior to screening;\n* 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;\n* 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\n\nExclusion Criteria:\n\n* Currently present or occured other malignancies within 3 years prior to first administration;\n* Known or suspected active acute graft versus host disease (aGVHD);\n* Presence of infection requiring treatment within 7 days prior to randomization;\n* Failed allogeneic hematopoietic stem cell transplantation within 6 months or 2 prior allogeneic hematopoietic stem cell transplants;\n* Use of Janus-activated kinase (JAK) inhibitors, Bruton's tyrosine kinase (BTK) inhibitors, or other, chemotherapeutic agents within 2 weeks prior to randomization;\n* Has a variety of factors that affect oral medications (e.g., inability to swallow, , intestinal obstruction, etc;\n* Those who have a history of psychotropic drug abuse and cannot be abstained from or have a mental disorder;\n* Have any severe or uncontrolled serious illness, including but not limited to uncontrolled hypertension, heart disease, hepatitis and epilepsy that require treatment;\n* Have any severe or uncontrolled serious illness, including but not limited to，uncontrolled hypertension heart disease, hepatitis and epilepsy that require treatment;\n* Those who are allergic to the study drug or its components;\n* Participation in other clinical trials or major surgery within 4 weeks prior to the first dose;\n* Subjects judged by the investigator to be unsuitable for enrollment;"}, 'identificationModule': {'nctId': 'NCT06300320', 'briefTitle': 'A Clinical Trial of TQ05105 Tablets in the Treatment of Chronic Graft-versus-host Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chia Tai Tianqing Pharmaceutical Group Co., Ltd.'}, 'officialTitle': 'A Randomized, Open-label, Multicenter Phase II Clinical Trial of Rovadicitinib in the Treatment of Third-line and Subsequent Moderate to Severe Chronic Graft-versus-host Disease (cGVHD).', 'orgStudyIdInfo': {'id': 'TQ05105-II-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TQ05105 Tablets', 'description': 'TQ05105 Tablets administered twice-daily. 28 days as a treatment cycle.', 'interventionNames': ['Drug: TQ05105 tablets']}], 'interventions': [{'name': 'TQ05105 tablets', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['TQ05105 Tablets']}]}, 'contactsLocationsModule': {'locations': [{'zip': '230001', 'city': 'Hefei', 'state': 'Anhui', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lianxin Liu, PhD', 'role': 'CONTACT', 'email': 'xiaoyuz@ustc.edu.cn', 'phone': '15255456091'}], 'facility': 'Anhui Provincial Hospital', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'zip': '730050', 'city': 'Lanzhou', 'state': 'Gansu', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Tao Wu, PhD', 'role': 'CONTACT', 'email': 'wutaozhen@yeah.net', 'phone': '13919939297'}], 'facility': "The 940th hospital of joint logistics support force of Chinese people's liberation army", 'geoPoint': {'lat': 36.05701, 'lon': 103.83987}}, {'zip': '510180', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shunqing Wang, PhD', 'role': 'CONTACT', 'email': 'drwangshq@medmail.com.cn', 'phone': '13437801998'}], 'facility': "Guangzhou First People's Hospital", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '530021', 'city': 'Nanning', 'state': 'Guangxi', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhongming Zhang, Master', 'role': 'CONTACT', 'email': 'zzmmissyou@126.com', 'phone': '15807801369'}], 'facility': 'The First Affiliated Hospital of Guangxi Medical University', 'geoPoint': {'lat': 22.81667, 'lon': 108.31667}}, {'zip': '050000', 'city': 'Shijiazhuang', 'state': 'Hebei', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xuejun Zhang, PhD', 'role': 'CONTACT', 'email': 'zhxjhbmu@126.com', 'phone': '13722781112'}], 'facility': 'The Second Hospital of Hebei Medical University', 'geoPoint': {'lat': 38.04139, 'lon': 114.47861}}, {'zip': '441021', 'city': 'Xiangyang', 'state': 'Hubei', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guolin Yuan, PhD', 'role': 'CONTACT', 'email': 'yuanguo1973@163.com', 'phone': '18696231603'}], 'facility': 'Xiangyang Central Hospital', 'geoPoint': {'lat': 32.0422, 'lon': 112.14479}}, {'city': 'Taian', 'state': 'Shangdong', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guanchen Bai, Bachelor', 'role': 'CONTACT', 'email': 'bgcbgc1@163.com', 'phone': '18653819776'}], 'facility': "Tai'an Central Hospital"}, {'zip': '200025', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaoxia Hu, PhD', 'role': 'CONTACT', 'email': 'hu_xiaoxia@126.com', 'phone': '13795437259'}], 'facility': 'Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '710299', 'city': "Xi'an", 'state': 'Shannxi', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Aili He, PhD', 'role': 'CONTACT', 'email': 'heaili@xiju.edu.cn', 'phone': '13891939962'}], 'facility': "The Second Affiliated Hospital of Xi'an Jiaotong University", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'zip': '300020', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Er lie Jiang, PhD', 'role': 'CONTACT', 'email': 'jiangerlie@ihcams.ac.cn', 'phone': '022-23909180'}], 'facility': 'Hematology Hospital of the Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'He Huang, PhD', 'role': 'CONTACT', 'email': 'hehuangyu@126.com', 'phone': '13605714822'}], 'facility': 'The First Affiliated Hospital, Zhejiang University School of Medicine', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '315040', 'city': 'Ningbo', 'state': 'Zhejiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ying Lu, Master', 'role': 'CONTACT', 'email': 'rmluying@nbu.edu.cn', 'phone': '13486090834'}], 'facility': "The Affiliated People's Hospital of Ningbo University", 'geoPoint': {'lat': 29.87819, 'lon': 121.54945}}], 'centralContacts': [{'name': 'He Huang, PhD', 'role': 'CONTACT', 'email': 'hehuangyu@126.com', 'phone': '13605714822'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chia Tai Tianqing Pharmaceutical Group Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}