Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2026-02-20 @ 6:46 AM
Study NCT ID:
NCT05241392
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-11
First Post:
2022-01-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of Anti-B7-H3 CAR-T Cell Therapy for Recurrent Glioblastoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005909', 'term': 'Glioblastoma'}], 'ancestors': [{'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D005910', 'term': 'Glioma'}, {'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': 'SEQUENTIAL', 'interventionModelDescription': 'a "3+3" design is used to determine Maximum Tolerated Dose (MTD) and the recommended phase 2 dose (RP2D)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-01-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-09', 'studyFirstSubmitDate': '2022-01-13', 'studyFirstSubmitQcDate': '2022-02-11', 'lastUpdatePostDateStruct': {'date': '2025-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Dose Limiting Toxicity (DLT)', 'timeFrame': 'three months post CAR-T cells infusion', 'description': 'To evaluate the DLT incidence occurred within three months after B7-H3 CAR-T cells infusion'}, {'measure': 'Safety：Incidence and severity of adverse events', 'timeFrame': 'three months post CAR-T cells infusion', 'description': 'To evaluate the possible adverse events occurred within three months after B7-H3 CAR-T cell infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity'}], 'secondaryOutcomes': [{'measure': 'Efficacy：Overall survival rate at 12 months', 'timeFrame': '12 months post CAR-T cells infusion', 'description': 'The proportion of subjects who have survived for more than 12 months since the diagnosis of recurrent glioblastoma'}, {'measure': 'Efficacy：objective remission rate', 'timeFrame': '1, 2, 3, 4, 5, 6 months post CAR-T cells infusion', 'description': 'The proportion of subjects reaching complete remission / partial remission in optimal remission'}, {'measure': 'pharmacokinetics：Cmax', 'timeFrame': 'Samples collected pre-injection, and 1, 2, 3, 5, 7, 9, 11,13 days post the first injection; Samples collected pre-injection, and 2, 7, 13 days post re-injections', 'description': 'observed maximum plasma concentration (Cmax)'}, {'measure': 'pharmacokinetics：Tmax', 'timeFrame': 'Samples collected pre-injection, and 1, 2, 3, 5, 7, 9, 11,13 days post the first injection; Samples collected pre-injection, and 2, 7, 13 days post re-injections', 'description': 'time to reach maximum plasma concentration (tmax)'}, {'measure': 'pharmacokinetics：AUC', 'timeFrame': 'Sample taken pre-injection, and 1, 2, 3, 5, 7, 9, 11,13 days post the first injection; Sample taken pre-injection, and 2,7,13 days post re-injections', 'description': 'area under the plasma concentration-time curve from time zero to 28 days after dosing (AUC(0-28))'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Glioblastoma']}, 'referencesModule': {'references': [{'pmid': '35468680', 'type': 'DERIVED', 'citation': 'Golubovskaya V. CAR-T Cells Targeting Immune Checkpoint Pathway Players. Front Biosci (Landmark Ed). 2022 Apr 2;27(4):121. doi: 10.31083/j.fbl2704121.'}]}, 'descriptionModule': {'briefSummary': 'This is an open, single-arm, dose-escalation and multiple-dose study to evaluate the safety, tolerability and preliminary effectiveness of B7-H3-targeting Chimeric Antigen Receptor-T (CAR-T) cell therapy on patients with recurrent glioblastomas. The study also plan to explore the Maximum Tolerated Dose (MTD) and determine the Recommended Phase II Dose (RP2D) of the CAR-T cell therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or female, aged 18-75 years (including 18 and 75 years old)；\n2. Patients with relapsed glioblastoma, as confirmed by positron emission tomography (PET) or histologic pathology；\n3. A \\>= 30% staining extent of B7-H3 in his/her primary/recurrent tumor tissue by the immunochemical method;\n4. Karnofsky scale score\\>=50\n5. Availability in collecting peripheral blood mononuclear cells (PBMCs) ；\n6. Adequate laboratory values and adequate organ function;\n7. Patients with childbearing/fathering potential must agree to use highly effective contraception；\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding females；\n2. Contraindication to bevacizumab；\n3. Within 5 days before the CAR-T cell infusion, subjects receiving systemic administration of steroids with dosage more than 10mg/d prednisone or the equivalent doses of other steroids ( not including inhaled corticosteroid)；\n4. Comorbid with Other uncontrolled malignancy；\n5. Active immunodeficiency virus (HIV) or hepatitis B virus or hepatitis C virus or tuberculosis infection;\n6. Subjects receiving the placement of a carmustine slow-release wafer within 6 months before the enrollment;\n7. Autoimmune diseases;\n8. Receiving long-term immunosuppressive treatment after organ transplantation;\n9. Severe or uncontrolled psychiatric diseases or condition that could increase adverse events or interfere the evaluation of outcomes;\n10. Not recovered from the toxicities or side effects by previous treatment;\n11. Subjects who have participated the other interventional trial within one month before the enrollment, or have received other CAR-T cell therapies or gene-modified cell therapy before enrollment.\n12. Subjects with medical conditions that affect signing the written informed consent or complying with the research procedures, the medical conditions including, but not limited to cardio-cerebral vascular diseases, renal dysfunction/failure, pulmonary embolism, coagulation disorders, active systemic infection, uncontrolled infection et. al; or patients who are unwilling or unable to comply with the research procedures; these\n13. Subjects with other conditions that would interfere trial participation at the investigator's discretion."}, 'identificationModule': {'nctId': 'NCT05241392', 'briefTitle': 'Safety and Efficacy Study of Anti-B7-H3 CAR-T Cell Therapy for Recurrent Glioblastoma', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tiantan Hospital'}, 'officialTitle': 'An Open, Single-arm, Phase 1 Study to Evaluate the Safety/Preliminary Effectiveness and Determine the Maximal Tolerated Dose of B7-H3-targeting CAR-T Cell Therapy in Treating Recurrent Glioblastomas', 'orgStudyIdInfo': {'id': 'TX103T-IG005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CAR-T cell therapy', 'description': 'Dose-escalation phase:\n\nA "3+3" dose-escalation design is used to determine MTD \\& R2PD. Anti-B7-H3 autologous CAR-T cells were given biweekly to patients at the following doses for each cycle, and 4 cycles as one course. Dose1: 3 patients at a dose of 20 million cells for each cycle. Dose 2: 3 patients at a dose of 60 million cells for each cycle. Dose 3: 3 patients at a dose of 150 million cells for each cycle. Dose 4: 3 patients at a dose of 450 million cells for each cycle. Dose 5: 3 patients at a dose of 900 million cells for each cycle.\n\nR2PD confirmation phase:\n\nDetermine the R2PD based on the results from the previous dose-escalation study; Treat another 12 patients with anti-B7-H3 autologous CAR-T cells biweekly at the R2PD to further confirm the safety of R2PD.\n\nAt each dose phase, if the patients show tolerate and response to the treatment, these patients would receive several courses of treatment at PI\'s discretion.', 'interventionNames': ['Biological: B7-H3-targeting CAR-T cells']}], 'interventions': [{'name': 'B7-H3-targeting CAR-T cells', 'type': 'BIOLOGICAL', 'description': 'Patients will be treated with anti-B7-H3 autologous CAR-T cells that are delivered into the intracranial tumor resection cavity or ventricular system using an Ommaya device.', 'armGroupLabels': ['CAR-T cell therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Tiantan Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Nan Ji, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Tiantan Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Tiantan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Yang Zhang', 'investigatorAffiliation': 'Beijing Tiantan Hospital'}}}}