Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
Study NCT ID:
NCT04139057
Status:
RECRUITING
Last Update Posted:
2024-10-23
First Post:
2019-10-23
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
EBV-Specific Anti-PD1 TCR-T Cells in the Treatment of EBV-Positive NHSCC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 18}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-22', 'studyFirstSubmitDate': '2019-10-23', 'studyFirstSubmitQcDate': '2019-10-23', 'lastUpdatePostDateStruct': {'date': '2024-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Maximum Tolerated Dose', 'timeFrame': '8 weeks', 'description': 'Verify the MTD of TCR-T cells for EBV antigen for treatment. 18 patients will be enrolled in this project, using a dose-escalation approach. The first group of patients will receive 5x10e6/kg TCR-T cells, the second group will receive 1x10e7/kg TCR-T cells, the third group will receive 5x10e7/kg TCR-T cells, the forth group will receive 1x10e8/kg. After confirmation of safety for 5×10e7 dose group, we then added IL-2 on this dose level for consecutive 6 patients. The remaining 6 pts are for enrollment of 1×10e8/kg dose level.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Head and Neck Squamous Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'Epstein-Barr virus (EBV) infections is known to be a high-risk factor to induce nasopharyngeal cancers. To date, EBV-related head and neck squamous cell carcinoma (HNSCC) is still a major concern in east Asia, especially in China. Concurrent therapies for HNSCC have limited response rate and high chance of relapse. However, EBV-induced cancers provided an ideal target for T cell-based immunotherapy due to the non-self origins. Engineered T cells bearing a TCR (TCR-T) that can specifically recognize the presented EBV antigen become a viable approach to treat this type of cancer. Though engineered T therapies have been well-recognized in hematological cancers, solid cancer treatment has been a major hurdle due to the immune-suppressive tumor microenvironment. One key mechanism of tumor-elicited suppression is the PDL1-PD1 interaction which induces T cell exhaustion. Therefore, TCR-T cells armed with a PD1 antagonist could further enhance the efficacy of TCR-T in solid cancers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Expected to live longer than 12 weeks\n* PS 0-2\n* Pathology confirmed as EBV positive HNSCC, either metastatic or recurrent disease\n* Creatinine \\<2.5mg/dl\n* ALT/AST is lower than three times ULN.\n* No contraindications of leukocyte collection\n* Before entering the trial, women must adopt a reliable method of contraception until 30 days after infusion.\n* Understand this trial and have signed an informed consent\n\nExclusion Criteria:\n\n* Patients with symptomatic brain metastasis\n* With other uncontrolled malignant tumors.\n* Hepatitis B or Hepatitis C activity period, HIV infected patients\n* Any other uncontrolled disease that interferes with the trial\n* Patients with severe heart and cerebrovascular diseases such as coronary heart disease, angina pectoris, myocardial infarction, arrhythmia, cerebral thrombosis and cerebral hemorrhage\n* Untreated hypertension or hypertensive patients\n* A person with a history of mental illness that is difficult to control\n* Researchers do not consider it appropriate to participate in this trial\n* Patients who have been using immunosuppressive agents for a long time after organ transplants, except for recent or current inhaled corticosteroids\n* Subjects who have been pregnant or nursing, or who plan for pregnancy within 2 months of treatment or after the end of treatment\n* An illness affects a person who signs a written consent or complies with a study procedure, or who is unwilling or unable to comply with the research requirements'}, 'identificationModule': {'nctId': 'NCT04139057', 'briefTitle': 'EBV-Specific Anti-PD1 TCR-T Cells in the Treatment of EBV-Positive NHSCC', 'organization': {'class': 'OTHER', 'fullName': 'Xinqiao Hospital of Chongqing'}, 'officialTitle': 'Single-Arm Trial of EBV-Specific TCR-T Cells With Anti-PD1 Auto-secreted Element in the Treatment of EBV-Positive Head and Neck Carcinoma', 'orgStudyIdInfo': {'id': 'XQDC20191001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EBV TCR-T', 'description': 'EBV-specific TCR-T cell with anti-PD1 auto-secreted element', 'interventionNames': ['Drug: EBV-specific TCR-T cell with anti-PD1 auto-secreted element']}], 'interventions': [{'name': 'EBV-specific TCR-T cell with anti-PD1 auto-secreted element', 'type': 'DRUG', 'description': 'Patients were pre-conditioned with chemotherapy and infused with EBV-specific TCR-T cells with anti-PD1 auto-secreted element', 'armGroupLabels': ['EBV TCR-T']}]}, 'contactsLocationsModule': {'locations': [{'zip': '400037', 'city': 'Chongqing', 'state': 'Chongqing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qingzhu Jia, MD', 'role': 'CONTACT', 'email': 'jiaqinghzu0801@outlook.com', 'phone': '152-2333-4184', 'phoneExt': '+86'}], 'facility': 'Department of Oncology, Xinqiao Hospital', 'geoPoint': {'lat': 29.56026, 'lon': 106.55771}}], 'centralContacts': [{'name': 'Qingzhu Jia, MD', 'role': 'CONTACT', 'email': 'jiaqingzhu0801@outlook.com', 'phone': '15223334184', 'phoneExt': '13647614555'}], 'overallOfficials': [{'name': 'Bo Zhu, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Army Medical University, China'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xinqiao Hospital of Chongqing', 'class': 'OTHER'}, 'collaborators': [{'name': 'TCRCure Biopharma Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Qingzhu Jia, M.D.', 'investigatorAffiliation': 'Xinqiao Hospital of Chongqing'}}}}