[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100517501":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":11,"locations":20,"responsibleParty":48,"collaborators":11,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":11,"eligibilityCriteria":56,"healthyVolunteers":52,"sex":57,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":11,"studyType":63,"phases":64,"briefSummary":67,"conditions":68,"keywords":72,"overallStatus":22,"whyStopped":11,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"Dushu Lake Hospital Affiliated to Soochow University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with R\u002FR HGG","EXPERIMENTAL",null,[13],"Biological: Allogenic B7-H3 CAR-γδT cell(QH104)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"BIOLOGICAL","Allogenic B7-H3 CAR-γδT cell(QH104)","Dose escalation (3+3) : dose 1 (1 × 10\\^7 CAR+cells) , dose 2 (3 × 10\\^7 CAR+cells), dose 3 (6× 10\\^7 CAR+cells), once every 4 weeks via an Ommaya reservoir or intrathecal administration.\n\nDose expansion 1: dose of RP2D, once every 4 weeks via an Ommaya reservoir or intrathecal administration.\n\nDose expansion 2: 3 × 10\\^7 CAR+cells, every two weeks for three consecutive months, then changed to once every 4 weeks via an Ommaya reservoir or intrathecal administration.",[9],[21],{"facility":5,"status":22,"city":23,"state":24,"zip":25,"country":26,"countryCode":27,"cosmosGeoPoint":28,"geoPoint":33,"contacts":34},"RECRUITING","Suzhou","Jiangsu","215125","China","CN",{"type":29,"coordinates":30},"Point",[31,32],120.59538,31.30408,{"lat":32,"lon":31},[35,40,44,46],{"name":36,"role":37,"phone":38,"phoneExt":11,"email":39},"Yulun Huang","CONTACT","+86 130 1388 9432","huangyulun@suda.edu.cn",{"name":41,"role":37,"phone":42,"phoneExt":11,"email":43},"Xuetao Li","+86 151 9563 7789","lixuetao0405@126.com",{"name":36,"role":45,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"name":41,"role":47,"phone":11,"phoneExt":11,"email":11},"SUB_INVESTIGATOR",{"type":49,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100517501","phase-1-clinical-study-on-the-treatment-of-malignant-brain-glioma-by-qh104-cell-injection-100517501",false,"NCT06018363","Clinical Study on the Treatment of Malignant Brain Glioma by QH104 Cell Injection","Allogeneic B7-H3 CAR-γδT Cell Therapy Recurrent\u002FProgressive High Grade Glioma（R\u002FR HGG）","Inclusion Criteria:\n\n* 1)Age 18-70 years old (both ends included), both male and female;\n* 2)At least one evaluable lesion, with previous biopsy or histopathological confirmation of high-grade glioma (WHO grade 3-4), and after comprehensive treatment, imaging examination indicates continued progression or recurrence;\n* 3\\) The pathological tissues removed by surgery can be used for immunohistochemical detection of target proteins (paraffin sections should be within half a year), and the expression of B7-H3 is positive;\n* 4\\) KPS ≥ 60 points;\n* 5)Expected survival \\> 3 months;\n* 6)Substantially normal bone marrow reserve function and normal liver and renal function (laboratory tests need to be fulfilled before receiving QH104 Cell Injection for the first time):White blood cell count (WBC) ≥ 3 x 10\\^9\u002FL;Lymphocyte count (LY) ≥ 0.8 x 10\\^9\u002FL;Hemoglobin (Hb) ≥ 90g\u002FL;Platelet (PLT) ≥80×10\\^9\u002FL;Albumin transaminase (ALT) \\& albumin transaminase (AST) \\\u003C1.5×ULN;Serum creatinine (Cr) \\\u003C1.5 x ULN;Total bilirubin \\\u003C 1.5 x ULN;PT \\& PTT ≤ 1.25 x ULN.\n* 7)No obvious hereditary diseases;\n* 8)Normal cardiac function with cardiac ejection index \\>55%;\n* 9)No bleeding and coagulation disorders;\n* 10)Women of childbearing age (15-49 years old) must have had a pregnancy test with a negative result within 7 days prior to the start of treatment, and subjects are willing to use contraception during the clinical trial and for 3 months after the last cell infusion;\n* 11\\) Sign the informed consent form.\n\nExclusion Criteria:\n\n* 1)Pregnant and lactating women;\n* 2)Those with organ failure:Heart: Class III and IV;Liver: up to grade C of the Child-Turcotte Liver -Function Classification;Kidney: chronic kidney disease stage 4 or above; renal insufficiency stage III or above;Lungs: symptoms of severe respiratory failure with involvement of other organs;Brain: central nervous system abnormalities or impaired consciousness;\n* 3)patients with combined second tumors;\n* 4)patients with active hepatitis B or C virus, HIV infection, or other untreated active infection;\n* 5)any severe, uncontrolled systemic autoimmune disease or any unstable systemic disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, ulcerative colitis, Crohn's disease, and temporal arteritis;\n* 6)Current systemic use of steroid cell (except for recent or current use of inhaled steroids) substances;\n* 7\\) have a chronic disease requiring immunologic or hormonal therapy;\n* 8\\) have an allergy to immunotherapy and related cells;\n* 9\\) 10)Patients with a history of organ transplantation or who are awaiting organ transplantation;\n* 10)Participation in other clinical trials within the previous 30 days;\n* 11)Those who are not suitable for clinical trials for other reasons in the opinion of the investigator.","ALL","18 Years","70 Years",{"count":61,"type":62},25,"ESTIMATED","INTERVENTIONAL",[65,66],"PHASE1","PHASE2","B7-H3 is expressed at low levels in normal tissues but overexpressed in various tumor tissues. The ubiquitous expression of B7-H3 in tumors of different grades is a key feature for brain gliomas. The immunohistochemistry study showed that B7-H3 is abundantly expressed on both glioma (especially high-grade glioma) cells and tumor-associated endothelial cells. For GBM, the expression of B7-H3 is intensely positive, especially on tumor cells and vascular endothelial cells, which makes B7-H3 a potential immunotherapeutic target.\n\nγδ T cells recognize tumor cells without being restricted by MHC molecules, and thus can be used in allogeneic therapy without the risk of causing graft-versus-host disease.\n\nThis study is an open-label, single-arm, dose-escalation and dose-expansion clinical study aimed at evaluating the safety and efficacy of allogeneic B7-H3 CAR γδT in patients with malignant glioma.",[69,70,71],"Brain Gliomas","High-Grade Gliomas","GBM",[73,74,75],"B7-H3","CAR-γδT","allogeneic","2025-08-13",{"date":78,"type":79},"2025-08-19","ACTUAL",{"date":81,"type":79},"2023-06-01",{"date":83,"type":62},"2027-12-31",{"name":5,"class":6},1]