Ignite Creation Date:
2025-12-24 @ 4:58 PM
Ignite Modification Date:
2026-01-25 @ 4:09 AM
Study NCT ID:
NCT06488950
Status:
RECRUITING
Last Update Posted:
2025-12-16
First Post:
2024-06-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of TIL in Advanced Solid Tumors (DFGD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-08', 'studyFirstSubmitDate': '2024-06-27', 'studyFirstSubmitQcDate': '2024-06-28', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': '6 months', 'description': 'To characterize the safety profile of TILs in patients with advanced 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': 'Percentage of patients that meet CR, PR and SD criteria set in this study according to RECIST 1.1'}, {'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 length between TIL infusion and confirmed subsequent disease progression according to RECIST 1.1'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Advanced Solid Tumor', 'Tumor Infiltrating Lymphocytes', 'Treatment Side Effects', 'Effects of Immunotherapy']}, 'descriptionModule': {'briefSummary': 'This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TIL) therapy in patients with advanced solid tumors. Autologous TILs and gene-edited TILs are expanded from tumor resections or biopsies and infused i.v. into the patient after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.'}, '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 TILs production and successfully produced；\n* Age: 18 years to 75years;\n* Histologically diagnosed as solid tumors;\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 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': 'NCT06488950', 'briefTitle': 'A Study of TIL in Advanced Solid Tumors (DFGD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Juncell Therapeutics'}, 'officialTitle': 'A Study Study of Tumor Infiltrating Lymphocytes Injection (GC101/203 TIL) in Patients With Advanced Solid Tumors', 'orgStudyIdInfo': {'id': 'GC101/203-2023-DFGD-ST'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm B', 'description': 'GC203 TILs will be infused i.v. to patients with advanced solid tumors after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.', 'interventionNames': ['Biological: GC203 TIL(gene-edited TIL) or autologous TILs']}, {'type': 'EXPERIMENTAL', 'label': 'Arm A', 'description': 'GC101 TILs will be infused i.v. to patients with advanced solid tumors after NMA lymphodepletion treatment with hydroxychloroquine(600mg,single-dose) and cyclophosphamide.', 'interventionNames': ['Biological: GC203 TIL(gene-edited TIL) or autologous TILs']}], 'interventions': [{'name': 'GC203 TIL(gene-edited TIL) or autologous TILs', 'type': 'BIOLOGICAL', 'description': 'the candidates will be assigned to GC203 TIL(gene-edited TIL) group or autologous TILs group according the volume of TIL sample', 'armGroupLabels': ['Arm A', 'Arm B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaoyun Tai', 'role': 'CONTACT'}, {'name': 'Qian Zhang', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Wenlong Yu', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Third Affiliated Hospital of Naval Medical University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'GC Clinical', 'role': 'CONTACT', 'email': 'clinicaltrials@juncell.com', 'phone': '086-18001759113'}], 'overallOfficials': [{'name': 'Qian Zhang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eastern Hepatobiliary Surgery Hospital'}, {'name': 'Wenlong Yu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eastern Hepatobiliary Surgery Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Juncell Therapeutics', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Eastern Hepatobiliary Surgery Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}