Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-27 @ 3:01 AM
Study NCT ID:
NCT06819293
Status:
RECRUITING
Last Update Posted:
2025-02-17
First Post:
2025-02-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IB-T101 Injection for Treatment of Patients with Advanced Clear Cell Renal Cell Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-12-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-13', 'studyFirstSubmitDate': '2025-02-05', 'studyFirstSubmitQcDate': '2025-02-05', 'lastUpdatePostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-12-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response rate', 'timeFrame': '3 years', 'description': 'To evaluate efficacy parameters such Objective Response Rate(ORR) per RECIST v1.1, as assessed by the Investigater'}, {'measure': 'AEs', 'timeFrame': '3 years', 'description': 'To characterize thesafty profile of autologous TIL injection IB-T101 in patients with advanced fclear renal cell carcinoma as measured by the incidence and severity of adverse events per CTCAE 5.0'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Clear Renal Cell Carcinoma', 'Adult']}, 'descriptionModule': {'briefSummary': 'This is an open label, single center, dose escalation, and dose extension IIT study aimed at evaluating the safety, efficacy, and pharmacokinetics of IB-T101 in adult patients with advanced clear renal cell carcinoma'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Voluntarily join the study, signed informed consent form， willing and able to comply with the study protocol;\n2. Age ≥18 years old;\n3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;\n4. Expected survival time of ≥ 3 months;\n\nExclusion Criteria:\n\n1. CNS dysfunction with clinical significance. For example, seizures, cerebral ischemia/hemorrhage, dementia, cerebellar diseases, cerebral edema, reversible posterior encephalopathy syndrome, or any autoimmune disease involving the CNS.\n2. Any form of primary and acquired immunodeficiency (such as severe combined immunodeficiency). Known human immunodeficiency virus (HIV) positive subjects\n3. Have experienced myocardial infarction or unstable angina within the 6 months prior to screening\n4. Pleural effusion requiring drainage for symptom management within 28 days prior to screening'}, 'identificationModule': {'nctId': 'NCT06819293', 'briefTitle': 'IB-T101 Injection for Treatment of Patients with Advanced Clear Cell Renal Cell Carcinoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Grit Biotechnology'}, 'officialTitle': 'A Phase I, Open Label, Single Center Study Evaluating the Safety and Efficacy of IB-T101 Injection for Treatment of Patients with Advanced Clear Cell Renal Cell Carcinoma', 'orgStudyIdInfo': {'id': 'GTE-002-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IB-T101 injection treatment group', 'interventionNames': ['Biological: IB-T101 injection']}], 'interventions': [{'name': 'IB-T101 injection', 'type': 'BIOLOGICAL', 'description': 'IB-T101 injection to treat advanced clear renal cell carcinoma', 'armGroupLabels': ['IB-T101 injection treatment group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Bo Liu', 'role': 'CONTACT', 'email': 'liubo0124@163.com', 'phone': '15927168582'}], 'facility': 'Tongji hospital, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Bo Liu', 'role': 'CONTACT', 'email': 'liubo0124@163.com', 'phone': '15927168582'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Grit Biotechnology', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}