Ignite Creation Date:
2025-12-24 @ 3:24 PM
Ignite Modification Date:
2026-01-05 @ 5:12 PM
Study NCT ID:
NCT03423992
Status:
UNKNOWN
Last Update Posted:
2021-06-15
First Post:
2018-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Personalized Chimeric Antigen Receptor T Cell Immunotherapy for Patients With Recurrent Malignant Gliomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005910', 'term': 'Glioma'}, {'id': 'D012008', 'term': 'Recurrence'}], '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'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016219', 'term': 'Immunotherapy, Adoptive'}], 'ancestors': [{'id': 'D019264', 'term': 'Adoptive Transfer'}, {'id': 'D007116', 'term': 'Immunization, Passive'}, {'id': 'D007114', 'term': 'Immunization'}, {'id': 'D007167', 'term': 'Immunotherapy'}, {'id': 'D056747', 'term': 'Immunomodulation'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2023-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-12', 'studyFirstSubmitDate': '2018-01-22', 'studyFirstSubmitQcDate': '2018-02-03', 'lastUpdatePostDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events attributed to the administration of the chimeric antigen receptor T cells', 'timeFrame': '1 year', 'description': 'Determine the toxicity profile of the chimeric antigen receptor T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.'}], 'secondaryOutcomes': [{'measure': 'Objective Response Rate', 'timeFrame': '1 year', 'description': 'The objective response rate (ORR) is defined as the proportion of patients who achieve radiographic partial or complete response (PR or CR) according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 guideline.'}, {'measure': 'clinical activity of chimeric antigen receptor T cells', 'timeFrame': '28 days', 'description': 'the number of infused chimeric antigen receptor T cells;'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glioma', 'Malignant Glioma of Brain', 'Recurrence Tumor']}, 'referencesModule': {'references': [{'pmid': '34235085', 'type': 'DERIVED', 'citation': 'Lin Q, Ba T, Ho J, Chen D, Cheng Y, Wang L, Xu G, Xu L, Zhou Y, Wei Y, Li J, Ling F. First-in-Human Trial of EphA2-Redirected CAR T-Cells in Patients With Recurrent Glioblastoma: A Preliminary Report of Three Cases at the Starting Dose. Front Oncol. 2021 Jun 21;11:694941. doi: 10.3389/fonc.2021.694941. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'A pilot study to determine the safety and efficacy of chimeric antigen receptor T cell (autologous T cells transduced with a lentiviral vector expressing chimeric antigen receptor with or without anti-PDL1 antibody) personalized immunotherapy for patients with recurrent malignant gliomas based on the expression of tumor specific/associated antigens (EGFRVIII, IL13Rα2, Her-2, EphA2, CD133, GD2).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Voluntary informed consent for entry of trial;\n* Age greater than 18 years, and less than 70 years;\n* Pathologically confirmed recurrent malignant gliomas;\n* Tumor cells from resected tissue must be available for antigen testing (EGFRvIII, IL13Rα2, Her-2, CD133, EphA2, GD2) and at least one of the targets should be tested positively by immunohistochemistry study;\n* If the patient is on dexamethasone, the anticipated dose must be 4 mg/day or less for at least 5 days prior to apheresis.\n* Patients must have a Karnofsky performance status of greater than or equal to 70.\n* Life expectancy greater than 3 months;\n* Participants with adequate organ function as measured by:\n\n 1. White blood count greater than or equal to 2500/mm\\^3; platelets greater than or equal to 100,000/mm\\^3, hemoglobin greater than or equal to 10.0 g/dL; without transfusion or growth factor support\n 2. Aspartate transaminase (AST), Alanine transaminase (ALT), gamma glutamyl transpeptidase (GGT), lactic acid dehydrogenase (LDH), alkaline phosphatase within 2.5 x upper normal limit, and total bilirubin less than or equal to 2.0 mg/dL\n 3. Serum creatinine less than or equal to 1.5 x upper limit of normal\n 4. Coagulation tests prothrombin time (PT) and partial thromboplastin time (PTT) have to be within normal limits, unless the patient has been therapeutically anti-coagulated for previous venous thrombosis.\n\nExclusion Criteria:\n\n* Female subjects of reproductive potential who are pregnant or lactating;\n* Previous treatment with any gene therapy products or other form immunotherapy;\n* Uncontrolled active infection.\n* Active or latent chronic hepatitis B \\[detectable hepatitis B surface antigen (HBsAg)\\] or active hepatitis C (positive serology \\[hepatitis C virus Ab\\]) infection.\n* HIV infection;\n* History of allergy or hypersensitivity to study product excipients (human serum albumin, Dimethyl sulfoxide, and Dextran 40);\n* Currently enrolled in other clinical trials;'}, 'identificationModule': {'nctId': 'NCT03423992', 'briefTitle': 'Personalized Chimeric Antigen Receptor T Cell Immunotherapy for Patients With Recurrent Malignant Gliomas', 'organization': {'class': 'OTHER', 'fullName': 'Xuanwu Hospital, Beijing'}, 'officialTitle': 'A Pilot Study to Evaluate the Safety and Efficacy of Personalized Chimeric Antigen Receptor T Cell Immunotherapy for Patients With Recurrent Malignant Gliomas Based on the Expression of Tumor Specific/Associated Antigens', 'orgStudyIdInfo': {'id': 'Xuanwu hospital'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Biological: Chimeric antigen receptor T cells', 'interventionNames': ['Biological: chimeric antigen receptor T cells']}], 'interventions': [{'name': 'chimeric antigen receptor T cells', 'type': 'BIOLOGICAL', 'description': 'chimeric antigen receptor T cells expressing receptors specific for EGFRvIII, IL13Rα2, Her-2, CD133, EphA2, GD2, respectively', 'armGroupLabels': ['Biological: Chimeric antigen receptor T cells']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100054', 'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ye Cheng, M.D.', 'role': 'CONTACT', 'email': 'chengye@xwhosp.org', 'phone': '8610-83192683'}, {'name': 'Qingtang Lin, M.D., Ph.D.', 'role': 'CONTACT', 'email': 'linqingtang@xwhosp.org', 'phone': '8610-83192683'}, {'name': 'Qingtang Lin, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Feng Ling, M.D., Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ye Cheng, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Xuanwu Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xuanwu Hospital, Beijing', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beijing Mario Biotech Company', 'class': 'UNKNOWN'}, {'name': 'Hebei Senlang BIotech Company', 'class': 'UNKNOWN'}, {'name': 'Beijing HuiNengAn Biotech Company', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Department of Neurosurgery', 'investigatorFullName': 'Qingtang Lin', 'investigatorAffiliation': 'Xuanwu Hospital, Beijing'}}}}