Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2025-12-26 @ 1:18 PM
Study NCT ID:
NCT03891706
Status:
RECRUITING
Last Update Posted:
2024-09-19
First Post:
2019-03-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Individualized Tumor Specific TCR- T Cells in the Treatment of Advanced Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007376', 'term': 'Interleukin-2'}], 'ancestors': [{'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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-13', 'studyFirstSubmitDate': '2019-03-24', 'studyFirstSubmitQcDate': '2019-03-25', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with treatment-related adverse events as assessed by CTCAE v4.03', 'timeFrame': 'At least 45 days', 'description': 'Keep records the adverse events experienced by subjects in 30 days after the last infusion.'}], 'secondaryOutcomes': [{'measure': 'Disease Control Rate(DCR)', 'timeFrame': 'one year', 'description': 'DCR is defined as the proportion of patients with tumor size reduction(CR,PR) and stable (SD) assessed by RECIST 1.1 and iRECIST'}, {'measure': 'overall survival(OS)', 'timeFrame': 'two year', 'description': 'The time from the first injection of Investigational Product until death'}, {'measure': 'progression-free survival(PFS)', 'timeFrame': 'two year', 'description': 'PFS is defined as the time from the first injection of Investigational Product until objective tumor progression or death, whichever occurs first.Assessed by RECIST 1.1 and iRECIST'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TCR-T'], 'conditions': ['Solid Tumor']}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to evaluate the safety of the tumor-specific TCR-T cells in the treatment of advanced Solid Tumor .\n\nThe secondary purpose of this study is to preliminarily showed the effect of TCR-T cells in the treatment of advanced Solid Tumor .', 'detailedDescription': 'This study is an open, single-center, phase I clinical trial which is aim to evaluate the safety and tolerability of tumor-specific TCR-T cells. In this study, these TCR-T cells will be multiplied, or grown, in the laboratory.Subjects will received TCR-T cells infusions twice at day 0 and day 14, with the use of IL-2 for 5 consecutive days after every cell infusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Aged between 18 and 70 years old, regardless of gender;\n2. Diagnosed as solid tumors by histopathology, and the tumor lesions could be detected or evaluated;\n3. Be after standard treatment or who lack effective treatment programs;\n4. Patients and their families were willing to participate in the clinical trial and signed the informed consent;\n5. Physical status: ECOG score 0-1;\n6. Expected survival time \\> 3 months;\n7. HIV antibody negative;Hepatitis b surface antigen negative;Hepatitis c antibody negative;The results of blood routine and coagulation were roughly normal, lymphocyte \\>0.8×10\\^9/L, hemoglobin \\>100g/L, and the pregnancy test of female patients with fertility potential was negative.\n8. Left ventricular ejection fraction 50% as indicated by cardiac ultrasound;Upper normal level of serum ALT/AST \\< 2.5 times;Serum creatinine 1.6mg/dl;Total bilirubin 1.5mg/dl, subject's total bilirubin \\< 3mg/dl except for Gilberts Syndrome;\n9. At least 4 weeks after the last systemic treatment, the patient's toxic and side effects must be restored to grade 1 or lower (except for alopecia or vitiligo).If the subject undergoes minor surgery within 3 weeks prior to enrollment, as long as all toxicity is recovered to level 1 or lower, the subject will meet the enrollment requirements.\n10. During the whole study period, patients can regularly visit the enrolled research institutions for relevant detection, evaluation and management;\n11. The patient is not allowed to use any anti-tumor drugs or treatments for 4 weeks prior to the infusion of TCR-T cells;\n12. Patients' tumor lesions can be obtained by surgery or puncture, and tumor infiltrating T cells can be successfully isolated from the obtained tumor tissue;\n13. T cells in patients' peripheral blood can effectively proliferate and expand by at least 10 times in the Pre-culture;\n14. The benefits of participating in the clinical trial outweigh the risks,which was evaluated by the researchers base on the status or condition of the patients.\n\nExclusion Criteria:\n\n1. Any form of primary immunodeficiency disease (such as severe combined immunodeficiency disease);\n2. Experiencing moderate to severe infection or possible opportunistic infection;\n3. Patients with a history of autoimmunity (e.g., SLE, psoriasis, etc.);\n4. Acute systemic infection, coagulation dysfunction or other serious cardiopulmonary diseases;\n5. Patients who have is suffering a large amount of glucocorticoid or other immunosuppressive agents within 4 weeks;\n6. Be allergic to any drug used in this study;\n7. Central nervous system metastases patients with clinically unstable or acute meningitis (except these clinically stable after treatment) Clinical stability needs to be met as follows: 4 weeks at least before the trial treatment, 1) no new brain lesion or no expanded of the original lesions confirmed by MRI); 2) no hormone therapy for at least 2 weeks; 3) neurological symptoms have returned to baseline;\n8. Pregnant and lactating women, as well as male and female patients who could not cooperate with contraception during the study period."}, 'identificationModule': {'nctId': 'NCT03891706', 'briefTitle': 'Individualized Tumor Specific TCR- T Cells in the Treatment of Advanced Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Guangzhou FineImmune Biotechnology Co., LTD.'}, 'officialTitle': 'An Open, Single-center, Stage I Clinical Study of Individualized Tumor Specific TCR-T Cells in the Treatment of Advanced Solid Tumors.', 'orgStudyIdInfo': {'id': 'FI-FIT001-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TCR-T cell infusion', 'description': 'Patient will exposed to Individualized Tumor-t Cell Receptor (TCR) -Mediated T Cells therapy', 'interventionNames': ['Drug: tumor-specific TCR-T cells', 'Drug: Interleukin-2']}], 'interventions': [{'name': 'tumor-specific TCR-T cells', 'type': 'DRUG', 'otherNames': ['TCR-T cells', 'FIT-001'], 'description': 'On day 0 and day 14, 0.5-5x10\\^9 TCR-T cells will be infused intravenously (IV) over 1 hour,patients may choose to receive more cell infusions if they benefit from the treatment.', 'armGroupLabels': ['TCR-T cell infusion']}, {'name': 'Interleukin-2', 'type': 'DRUG', 'otherNames': ['IL-2'], 'description': 'Aldesleukin 3,000,000 IU. IV.QD beginning within 24 hours of cell infusion and continuing for up to 5 days .', 'armGroupLabels': ['TCR-T cell infusion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510700', 'city': 'Guangzhou', 'state': 'Gaungdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xuzhi Pan', 'role': 'CONTACT', 'email': 'panxzh@sysucc.org.cn', 'phone': '86-20-87343135'}, {'name': 'Xiaoshi Zhang, professor', 'role': 'CONTACT'}], 'facility': 'Sun Yat-sen University Cancer Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'centralContacts': [{'name': 'Xuzhi Pan', 'role': 'CONTACT', 'email': 'panxzh@sysucc.org.cn', 'phone': '86-20-87343135'}, {'name': 'Haiping Liu', 'role': 'CONTACT', 'email': 'liuhp11@fineimmu.com', 'phone': '020-31605836'}], 'overallOfficials': [{'name': 'Penghui Zhou', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Guangzhou FineImmune Biotechnology Co., LTD.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Guangzhou FineImmune Biotechnology Co., LTD.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Sun Yat-sen University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}