Ignite Creation Date:
2025-12-25 @ 4:54 AM
Ignite Modification Date:
2025-12-26 @ 3:54 AM
Study NCT ID:
NCT04943718
Status:
UNKNOWN
Last Update Posted:
2021-06-29
First Post:
2021-06-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Personalized Vaccine for Patients With Recurrent Malignant Glioma
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2024-06-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-26', 'studyFirstSubmitDate': '2021-06-13', 'studyFirstSubmitQcDate': '2021-06-26', 'lastUpdatePostDateStruct': {'date': '2021-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidences of advent events and severe advent events', 'timeFrame': 'from initiation of study treatment to 28 weeks post-vaccination', 'description': 'would be monitored and measured according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 4.X.)'}], 'secondaryOutcomes': [{'measure': 'object response rate (ORR) according to iRANO criteria', 'timeFrame': 'from initiation of study treatment to 24 weeks post-vaccination (last shot)', 'description': 'ORR including complete response (CR) and partial response (PR) would be assessed and measured based on the conditions proposed by iRANO criteria'}, {'measure': 'progression free survival (PFS)', 'timeFrame': 'up to 48 weeks post-vaccination(last shot)', 'description': 'time interval (measured in weeks) between initiation of study treatment to progression of disease'}, {'measure': 'overall survival (OS)', 'timeFrame': 'up to 48 weeks post-vaccination(last shot)', 'description': 'time interval (measured in weeks) from initiation of study treatment to the death of patients'}, {'measure': 'immune response based on the criteria encoded by GRT-C903 and GRT-R904', 'timeFrame': 'Baseline to end of treatment (up to approximately 12 months)', 'description': 'humoral and cellular immune responses including generation of specific antibodies, inflammatory factors, immune cells, will be measured as proposed by GRT-C903 and GRT-R904'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Malignant Glioma', 'Recurrent Glioma']}, 'descriptionModule': {'briefSummary': 'A single-arm, single-center, open-labeled study will be conducted with an aim to investigate the feasibility, safety, and efficacy of the personalized vaccine for patients with recurrent malignant glioma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* age 18-70;\n* signed inform consent;\n* patients with recurrent malignant glioma; have received surgery, radiotherapy, chemotherapy;\n* patients' tumor tissue should have a high mutation load(\\>10 TMB); be genetically unstable; at least have 10 neoantigens;\n* should be able to provide tumor tissue and peripheral blood for sequencing and flow cytometry analysis;\n* at least three months post last operation; one month after the completion of the last anti-drug therapy or radiotherapy;\n* have not received any immune therapy;\n* at least have one measurable lesion;\n* KPS \\>60;\n* estimated survival \\> 3 months\n* patients should have adequate organ and bone marrow function;\n\nExclusion Criteria:\n\n* female patient is breastfeeding or pregnant;\n* known history of allergy to peptides or other stimulating factors (i.e. GM-CSF);\n* known history of Graft-Versus-Host Disease (GVHD);\n* participation in gene therapy;\n* other malignancy;\n* systemic disease: i.e., severe infection; HIV;\n* other conditions upon investigator's judgement;"}, 'identificationModule': {'nctId': 'NCT04943718', 'briefTitle': 'Personalized Vaccine for Patients With Recurrent Malignant Glioma', 'organization': {'class': 'OTHER', 'fullName': 'Xuanwu Hospital, Beijing'}, 'officialTitle': 'Personalized Vaccine for Patients With Recurrent Malignant Glioma: a Single-arm, Single-center, Open-labeled Study', 'orgStudyIdInfo': {'id': '2019-127'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'personalized vaccine', 'description': 'patients with recurrent malignant gliomas enrolled into this arm will receive the personalized vaccine through sub-cutaneous.', 'interventionNames': ['Biological: personalized vaccine']}], 'interventions': [{'name': 'personalized vaccine', 'type': 'BIOLOGICAL', 'description': 'Based on genetic and transcriptional sequencing information, personalized peptide vaccines would be designed and produced; patients would be vaccinated on day 1, 4, 8 ,15, 22 and then on week 12, 20.', 'armGroupLabels': ['personalized vaccine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100054', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ye Cheng, M.D.', 'role': 'CONTACT', 'email': 'chengye@xwhosp.org', 'phone': '8610-83188114', 'phoneExt': '2683'}, {'name': 'Qingtang Lin, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ye Cheng, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Xuanwu Hospital, Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Qingtang Lin, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'linqingtang@xwhosp.org', 'phone': '8610-83198114', 'phoneExt': '2683'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xuanwu Hospital, Beijing', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beijing Neoantigen Biotechnology Company', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, glioma immunotherapy program', 'investigatorFullName': 'Qingtang Lin', 'investigatorAffiliation': 'Xuanwu Hospital, Beijing'}}}}