Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-01-01 @ 9:10 PM
Study NCT ID:
NCT06453057
Status:
RECRUITING
Last Update Posted:
2025-02-17
First Post:
2024-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Autologous Tumor-Infiltrating Lymphocyte (GT307) for Treatment of Patients with Solid Tumours
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-06-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-13', 'studyFirstSubmitDate': '2024-06-07', 'studyFirstSubmitQcDate': '2024-06-07', 'lastUpdatePostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-06', '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（GT307) in patients with relapsed/metastatic advanced solid tumor as measured by the incidence and severity of adcersed events per CTCAE 5.0'}, {'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'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Adult']}, 'descriptionModule': {'briefSummary': 'This study is a single arm, open design aimed at evaluating the safety and tolerability of Autologous Tumor-Infiltrating Lymphocyte (GT307) for treatment of patients with solid tumours,while evaluating pharmacokinetic characteristics and efficacy assessment to determine the optimal biological dose (OBD).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Voluntarily join the study, signed informed consent form， willing and able to comply with the study protocol;\n* 2\\. Age 18 to 70 years old;\n* 3\\. Ovarian cancer that progresses after recurrence or first-line chemotherapy；\n* 4\\. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;\n* 5\\. Expected survival time of ≥ 12 weeks;\n* 6\\. Good function of vital organs;\n* 7\\. Subjects entering this study due to disease progression must have an imaging record of disease progression before tumor sampling;\n* 8\\. At least one measurable target lesion that meets the definition of RECIST v1.1 after tumor sampling.\n\nExclusion Criteria:\n\n* 1.Patients with uncontrollable tumor-related pain as judged by the investigator; participants requiring analgesic medication must already have a stable analgesic regimen at the time of study entry; symptomatic lesions suitable for palliative radiotherapy should be completed prior to study entry;\n* 2.Known mental illness, alcoholism, drug use or substance abuse;\n* 3.Pregnant or lactating women; or women who are pregnant, breastfeeding, or planning to become pregnant within 1 year after cell infusion;\n* 4.Those who have received other clinical trial drug treatment within 4 weeks before preconditioning by lymphodepletion,plan to participate in other clinical trial drug treatment during the study;\n* 5.The investigators determine that other conditions that make the patient not suitable for enrollment.'}, 'identificationModule': {'nctId': 'NCT06453057', 'briefTitle': 'Autologous Tumor-Infiltrating Lymphocyte (GT307) for Treatment of Patients with Solid Tumours', 'organization': {'class': 'INDUSTRY', 'fullName': 'Grit Biotechnology'}, 'officialTitle': 'A Single-arm Clinical Study of Autologous Tumor-Infiltrating Lymphocyte (GT307) for Treatment of Patients with Solid Tumours', 'orgStudyIdInfo': {'id': 'GRIT-CD-CHN-307-005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GT307 injection treatment group', 'interventionNames': ['Biological: GT307 injection']}], 'interventions': [{'name': 'GT307 injection', 'type': 'BIOLOGICAL', 'description': 'GT307 injection to treat solid tumours', 'armGroupLabels': ['GT307 injection treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200011', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Kang Yu, PHD', 'role': 'CONTACT', 'email': 'kangyu1489@fckyy.org.cn', 'phone': '+86 （021）63455050', 'phoneExt': '8571'}], 'facility': 'Obstetrics & Gynecology Hospital of Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Kang Yu, PHD', 'role': 'CONTACT', 'email': 'kangyu1489@fckyy.org.cn', 'phone': '+86 （021）63455050', 'phoneExt': '8571'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Grit Biotechnology', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}