Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-27 @ 11:31 PM
Study NCT ID:
NCT05430360
Status:
RECRUITING
Last Update Posted:
2025-02-17
First Post:
2022-06-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autologous Tumor-infiltrating Lymphocyte Injection (GT201) for the Treatment of Metastatic/recurrent Advanced Solid Tumors
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': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-13', 'studyFirstSubmitDate': '2022-06-04', 'studyFirstSubmitQcDate': '2022-06-19', 'lastUpdatePostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and severity of adcersed events per CTCAE 5.0', 'timeFrame': '3 years', 'description': 'To characterize the safety profile of autologous TIL injection（GT201) in patients with relapsed/metastatic advanced solid tumor as measured by the incidence and severity of adcersed events per CTCAE 5.0'}], 'secondaryOutcomes': [{'measure': 'Objective response rate', 'timeFrame': '3 years', 'description': 'To evaluate efficacy parameters such Objective Response Rate (ORR) per RECIST 1.1, as assessed by the Investigator'}, {'measure': 'Progression-free survival', 'timeFrame': '3 years', 'description': 'To evaluate efficacy parameters such Progression-Free Survival (PFS) per RECIST 1.1, as assessed by the Investigator'}, {'measure': 'Overall survival', 'timeFrame': '3 years', 'description': 'To evaluate efficacy parameters such Overall Survival (OS)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Solid Tumor']}, 'descriptionModule': {'briefSummary': 'This study is a single-center, single-arm phase I clinical trial. A total of 30 subjects (20 evaluable cases are expected) from 1 cohort will be enrolled in this study.\n\nAn "autologous tumor-infiltrating lymphocyte therapy" dosing regimen consisting of lymphodepleting chemotherapy (FC regimen: cyclophosphamide + fludarabine), infusion of autologous tumor-infiltrating lymphocyte injection, and interleukin-2 injection will be used.The study process is divided into: screening period, sampling and production period, clearing and chemotherapy period, treatment and observation period, and follow-up period'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Voluntarily enrolled in the study, signed an informed consent form, and willing and able to comply with the study protocol\n2. At least one lesion (preferably superficial lymph nodes) that has not been treated with radiation, has not received other local therapies, has access to tumor tissue, and can isolate at least a mass ≥ 1.0 g of tissue mass (either single lesion source or multiple lesions combined) for the preparation of autologous tumor-infiltrating lymphocytes\n3. Eastern Collaborative Oncology Group (ECOG) physical fitness status score of 0 or 1.\n\nExclusion Criteria:\n\n1. Failure of surgery and/or radiation therapy to relieve spinal cord compression is not eligible for enrollment\n2. People with uncontrolled tumor-related pain as judged by the investigator\n3. Risk of major bleeding as assessed by investigators\n4. Have interstitial pneumonia or clinically significant active pneumonia at screening, or other respiratory disease that severely affects lung function\n5. Any active autoimmune disease 14 days prior to clear lymphatic chemotherapy, history of autoimmune disease, or disease requiring systemic steroid hormone or immunosuppressive drug therapy 6:History of allergic reaction to any component of the drugs to be used in the study (including but not limited to autologous tumor infiltrating lymphocytes, cyclophosphamide, fludarabine, interleukin-2, dimethyl sulfoxide (DMSO), human serum albumin (HSA), dextran-40, antibiotics (beta-lactam antibiotics, gentamicin));\n\n7：Women who are pregnant or breastfeeding; or women who are pregnant, breastfeeding, or planning to become pregnant within 1 year of the cell return.'}, 'identificationModule': {'nctId': 'NCT05430360', 'acronym': 'GT201', 'briefTitle': 'Autologous Tumor-infiltrating Lymphocyte Injection (GT201) for the Treatment of Metastatic/recurrent Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Grit Biotechnology'}, 'officialTitle': 'Single-center, Single-arm Phase I Clinical Study of Autologous Tumor-infiltrating Lymphocyte Injection (GT201) for the Treatment of Metastatic/recurrent Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'GRIT-CO-FA-018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GT201 treatment group', 'description': 'Autologous tumor infiltrating lymphocyte injection', 'interventionNames': ['Biological: GT201']}], 'interventions': [{'name': 'GT201', 'type': 'BIOLOGICAL', 'description': 'Autologous tumor infiltrating lymphocyte injection', 'armGroupLabels': ['GT201 treatment group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Weijia Fang, PhD', 'role': 'CONTACT'}], 'facility': 'The First Hospital of Zhejiang University', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Weijia Fang, PhD', 'role': 'CONTACT', 'email': 'weijiafang@zju.edu.cn', 'phone': '137 5821 1655'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Grit Biotechnology', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}