Ignite Creation Date:
2025-12-24 @ 11:21 PM
Ignite Modification Date:
2025-12-25 @ 9:04 PM
Study NCT ID:
NCT07256756
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-23
First Post:
2025-11-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of GC203 TIL in Advanced Solid Tumors (NF)
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': 8}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2028-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2025-11-20', 'studyFirstSubmitQcDate': '2025-11-20', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': '6 month', 'description': 'To characterize the safety profile of GC203 TIL in patients with Solid Tumors who were failed to standard treatment as assessed by incidence of adverse events.'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate (ORR)', 'timeFrame': 'Up to 36 months', 'description': 'Proportion of patients with response per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)'}, {'measure': 'Disease Control Rate (DCR）', 'timeFrame': 'Up to 36 months', 'description': 'Proportion of patients with response per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)'}, {'measure': 'Duration of Response (DOR)', 'timeFrame': 'Up to 36 months', 'description': 'The time length between the first confirmed objective response per RECIST 1.1 to the treatment and the subsequent disease progression per RECIST 1.1'}, {'measure': 'Progression-Free Survival (PFS)', 'timeFrame': 'Up to 36 months', 'description': 'The time from TIL infusion until disease progression or death from any cause.'}, {'measure': 'Overall Survival(OS)', 'timeFrame': 'Up to 36 months', 'description': 'The time from TIL infusion until death from any cause.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Solid Tumors, Adult']}, 'descriptionModule': {'briefSummary': 'This study is a prospective, open-label, single-arm clinical trial aimed at evaluating the safety and efficacy of GC203 TIL therapy in treating malignant solid tumors that have failed standard treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* have one the tumor resection for gene-edited GC203 TIL production and successfully produced；\n* Age: 18 years to 75years;\n* Histologically diagnosed as solid tumor;\n* Expected life-span more than 3 months;\n* ECOG score 0-1;\n* Test subjects have failed standard treatment regimens, and be willing to receive engineered GC203 TIL therapy;\n* At least 1 evaluable tumor lesion;\n\nExclusion Criteria:\n\n* with other malignant tumors,except for the malignancies that have been cured, have been inactive for ≥5 years prior to study inclusion and have a very low risk of recurrence; Non-melanoma skin cancer or malignant lentigo with adequate treatment and no evidence of disease recurrence; Carcinoma in situ with adequate treatment and no evidence of disease recurrence;\n* Need glucocorticoid treatment, and daily dose of Prednisone greater than 10mg(or equivalent doses of hormones) or outoimmune diseases requiring immunomodulatory treatment;\n* Breathe indoor air in a quiet state, and the oxygen saturation of finger pulse is \\< 95%;\n* Human immunodeficiency virus (HIV) infection or anti-HIV antibody positive, active HBV or HCV infection (HBsAg positive and/or anti-HCV positive), syphilis infection or Treponema pallidum antibody positive;\n* Significant cardiovascular anomalies'}, 'identificationModule': {'nctId': 'NCT07256756', 'briefTitle': 'A Study of GC203 TIL in Advanced Solid Tumors (NF)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Juncell Therapeutics'}, 'officialTitle': 'A Phase I Study of Engineered Tumor Infiltrating Lymphocytes Injection (GC203 TIL) in Patients With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'GC203-2025-NF-ST'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GC203 TIL', 'description': 'participants with advanced solid tumors using cryopreserved GC203 TIL', 'interventionNames': ['Biological: GC203 TIL']}], 'interventions': [{'name': 'GC203 TIL', 'type': 'BIOLOGICAL', 'description': 'A tumor sample is resected from each participant and cultured ex vivo to expand the population of engineered tumor infiltrating lymphocytes injection (GC203 TIL). After lymphodepletion, patients are infused GC203 TIL.', 'armGroupLabels': ['GC203 TIL']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ying Cheng', 'role': 'CONTACT', 'email': 'ying.cheng@juncell.com', 'phone': '+8621-69110327'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Juncell Therapeutics', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Shenzhen Hospital of Southern Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}