Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2026-02-26 @ 7:24 PM
Study NCT ID:
NCT05649618
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-12-14
First Post:
2022-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TIL Cells for the Treatment of the Advanced Solid Tumors Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C024352', 'term': 'fludarabine'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D007376', 'term': 'Interleukin-2'}], 'ancestors': [{'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D007378', 'term': 'Interleukins'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D008222', 'term': 'Lymphokines'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-12-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-11', 'studyFirstSubmitDate': '2022-10-26', 'studyFirstSubmitQcDate': '2022-12-11', 'lastUpdatePostDateStruct': {'date': '2022-12-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose Limiting Toxicity', 'timeFrame': 'up to Day 28', 'description': 'Dose Limiting Toxicity (DLT) is defined as patients with the adverse event (AE) or laboratory abnormality recognized by Investigators, and should be possibly related to TILs therapy.'}, {'measure': 'Adverse Event', 'timeFrame': 'up to 24 months', 'description': 'The severity and incidence of various adverse events and serious adverse events'}], 'secondaryOutcomes': [{'measure': 'Overall response rate(ORR)', 'timeFrame': 'up to 24 months'}, {'measure': 'Progression free survival (PFS)', 'timeFrame': 'up to 24 months'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'up to 24 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Solid Tumor']}, 'descriptionModule': {'briefSummary': 'This study is to investigate the safety and efficacy of tumor infiltrating lymphocyte (TILs) therapy in patients with Advanced malignant solid tumors. TILs are expanded from tumor resections or biopsies, and after ex vivo stimulation, activation and extensive expansion, are reinfused to patients after non-myeloablative lymphocyte-depleting preparative regimen.', 'detailedDescription': 'This is a single-center, open-label, Phase I clinical study of TILs for the treatment of the recurrent/metastatic solid tumors patients who had failed standard therapy.\n\nTILs are expanded from tumor resections or biopsies, and after ex vivo stimulation, activation and extensive expansion, are reinfused to patients after non-myeloablative lymphocyte-depleting preparative regimen.\n\nThe primary purpose of this study is to evaluate the safety and tolerability of TILs in patients with recurrent/metastatic solid tumors.\n\nThe second purpose of this study is to preliminarily explore the effectiveness of TILs in patients with recurrent/metastatic solid tumors.\n\nEligibility:\n\nAdults aging 18-75 who were failed to standard treatment or have no standard treatment with recurrent/metastatic solid tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Have the willingness to communicate with investigator, be able to understand and follow the trail requirements, and voluntarily to participate in the trail;\n2. 18 \\~ 75 years;\n3. The expected survival period is at least 3 months;\n4. ECOG score of 0-1;\n5. There is at least one lesion that can be operated or biopsied for the preparation of TIL;\n6. According to RECIST 1.1 standard, there is at least one measurable target lesion for efficacy evaluation;\n7. Patients with recurrent or metastatic solid tumors confirmed by histopathology;\n8. Subjects who failed standard treatment in the past or have no standard treatment currently tor who are judged by the investigator to be unsuitable for current standard treatment for other reasons, and the objective imaging assessment is disease progression\n\nExclusion Criteria:\n\n1. Female subjects who are pregnant or breastfeeding, or have a positive blood pregnancy test at baseline ;\n2. Subjects who have had severe allergic reactions to any drug or its components in this trial in the past;\n3. Subjects who have received any investigational drug within 28 days before the infusion of TIL cells, or participated in another clinical study at the same time;\n4. Subjects who have other known history of malignant tumors in the past 5 years, except for localized tumors that have been cured, including in situ cervical carcinoma, basal cell carcinoma of the skin, and in situ prostate carcinoma;\n5. Patients who have received adoptive cell therapy in the past;\n6. According to the judgment of the investigator, the condition of the subject is not suitable for this trial.'}, 'identificationModule': {'nctId': 'NCT05649618', 'briefTitle': 'TIL Cells for the Treatment of the Advanced Solid Tumors Patients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Fujian Cancer Hospital'}, 'officialTitle': 'A Single-center, Open-label Clinical Study of TIL Cells for the Treatment of the Recurrent/Metastatic Solid Tumors Patients Who Had Failed Standard Therapy', 'orgStudyIdInfo': {'id': 'FJ001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Tumor Infiltrating Lymphocytes', 'description': 'TIL cells (2.5×10\\^9-5×10\\^10) will be infused i.v. to patients with advanced solid tumors after non-myeloablative lymphocyte-depleting preparative regimen.', 'interventionNames': ['Biological: Tumor Infiltrating Lymphocytes', 'Drug: Fludarabine', 'Drug: Cyclophosphamide Capsules', 'Drug: IL-2']}], 'interventions': [{'name': 'Tumor Infiltrating Lymphocytes', 'type': 'BIOLOGICAL', 'description': 'On day 0 patients will be intravenous infusion of TILs', 'armGroupLabels': ['Tumor Infiltrating Lymphocytes']}, {'name': 'Fludarabine', 'type': 'DRUG', 'description': 'Part of the non-myeloablative lymphocyte-depleting preparative regimen', 'armGroupLabels': ['Tumor Infiltrating Lymphocytes']}, {'name': 'Cyclophosphamide Capsules', 'type': 'DRUG', 'description': 'Part of the non-myeloablative lymphocyte-depleting preparative regimen.', 'armGroupLabels': ['Tumor Infiltrating Lymphocytes']}, {'name': 'IL-2', 'type': 'DRUG', 'description': 'Following cell infusion, the patient receives high-dose bolus IL-2, which is dosed to individual patient tolerance.', 'armGroupLabels': ['Tumor Infiltrating Lymphocytes']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'meifang Li', 'role': 'CONTACT', 'email': '362952772@qq.com', 'phone': '15985795022'}, {'name': 'zhiyong He', 'role': 'CONTACT', 'email': 'heyong1015@163.com', 'phone': '13805086391'}], 'overallOfficials': [{'name': 'zhiyong He', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fujian Cancer Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fujian Cancer Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}