Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2025-12-29 @ 12:45 AM
Study NCT ID:
NCT06156150
Status:
RECRUITING
Last Update Posted:
2023-12-05
First Post:
2023-11-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of B7-H4 in Tumor Vaccine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005910', 'term': 'Glioma'}], 'ancestors': [{'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019496', 'term': 'Cancer Vaccines'}], 'ancestors': [{'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-26', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-26', 'studyFirstSubmitDate': '2023-11-26', 'studyFirstSubmitQcDate': '2023-11-26', 'lastUpdatePostDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IHC analysis', 'timeFrame': '36 months', 'description': 'Different expression level of proteins (CD3,CD8,B7-H4 et.ac) in Gliomas with different grades and molecular subgroups (100 cases) will be measured using immunohistochemical.'}], 'secondaryOutcomes': [{'measure': 'Transcriptomics', 'timeFrame': '36 months', 'description': 'The issues collected will be used for transcriptome sequencing to measure gene expression level.'}, {'measure': 'Immunomics', 'timeFrame': '36 months', 'description': 'The issues collected will be used for TCR/BCR sequencing to measure clonality of lymphocytes'}, {'measure': 'Proteomics', 'timeFrame': '36 months', 'description': 'The issues collected will be used for proteomic sequencing to measure gene expression level in protein'}, {'measure': 'Radiomics', 'timeFrame': '36 months', 'description': 'The features from images will be extracted using algorithm of Deep-learning or Radiomics'}, {'measure': 'Genomics', 'timeFrame': '36 months', 'description': 'The issues collected will be used for whole genome sequencing or whole exome sequencing to measure gene mutations.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['glioma', 'treatment resistance', 'immunotherapy', 'cancer vaccine', 'macrophage'], 'conditions': ['Glioma']}, 'descriptionModule': {'briefSummary': 'Glioma patients have poor prognosis because of limited choices of treatment. Therapeutic cancer vaccines have been proved to improve survival in glioma, but resistance is a new challenge for vaccine treatment, and the mechanism is unclear. The applicant found in previous papers that glioma cells induced B7-H4 overexpression in macrophages, and the expression level of B7-H4 is highly correlated with vaccine resistance. Preliminary experiments indicated that B7-H4 protein in macrophages inhibited the expression of ATF3, STAT1 and CXCL9/10, which also resulted in decreased T cell infiltration in glioma model of mouse and was a negative factor of vaccine benefits. Therefore, the applicant hypothesize that B7-H4 inhibits STAT1 transcription by reducing expression of ATF3, resulting in decreased phosphorylated-STAT1 in nucleus, which inhibiting expression and secretion of chemokines 9/10. Thereby, reduced infiltration of T cells in microenvironment will be followed, which ultimately promotes resistance of vaccine treatment in glioma. The follow-up plan of this project will be conducted based on the cells, organoid platform and animal experiments to confirm the role and mechanism of macrophage-derived B7-H4 in secretion of chemokines for T cells and treatment resistance of vaccines. Moreover, the DC vaccine produced by team of the applicant will be used to assess the probability of reversing vaccine resistance when intervening B7-H4 axis. Finally, a model for evaluating clinical benefits from vaccine will be established based on data from clinical trials combining with expression of B7-H4 and clinicopathologic features. This study will provide new evidences for the treatment of cancer vaccines in gliomas.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing glioma surgery at Huashan Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nInclusion Criteria:\n\nThe patients with glioma in the Department of Neurosurgery of Huashan Hospital Affiliated to Fudan University who meet the following three conditions can be enrolled\n\n1. They were 18-80 years old, male and female;\n2. The pathological results of frozen section during operation were gliomas;\n3. Tissue (6 mm \\* 6 mm) can be used for cell sorting on the basis of not affecting clinical routine diagnosis;\n4. Sign informed consent.\n\nExclusion Criteria:\n\nPatients who meet any of the following criteria will not be included in this study:\n\n1. Participants in other clinical trials;\n2. Pregnant women.'}, 'identificationModule': {'nctId': 'NCT06156150', 'briefTitle': 'The Role of B7-H4 in Tumor Vaccine', 'organization': {'class': 'OTHER', 'fullName': 'Huashan Hospital'}, 'officialTitle': 'The Role and Mechanism of B7-H4/ATF3 Axis From Glioma Associated Macrophages in Treatment Resistance of Cancer Vaccine', 'orgStudyIdInfo': {'id': 'KY2023-997'}, 'secondaryIdInfos': [{'id': '8230162487', 'type': 'OTHER_GRANT', 'domain': 'The National Natural Science Foundation of China'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'glioma patients receiving conventional treatment', 'description': 'surgery+radiotherapy+chemotherapy'}, {'label': 'glioma patients with tumor vaccine', 'description': 'surgery+radiotherapy+chemotherapy+tumor vaccine', 'interventionNames': ['Biological: tumor vaccine']}], 'interventions': [{'name': 'tumor vaccine', 'type': 'BIOLOGICAL', 'description': 'DC vaccine produced by the Team', 'armGroupLabels': ['glioma patients with tumor vaccine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200040', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Di Chen, MD', 'role': 'CONTACT', 'email': 'dichen18@fudan.edu.cn', 'phone': '54602851'}, {'name': 'Di Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Di Chen', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Huashan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Yu Yao, MD', 'investigatorAffiliation': 'Huashan Hospital'}}}}