[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100590232":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":115,"centralContacts":119,"locations":125,"responsibleParty":145,"collaborators":123,"id":148,"slug":149,"hasResults":150,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":123,"eligibilityCriteria":154,"healthyVolunteers":150,"sex":155,"minAge":156,"maxAge":123,"enrollmentInfo":157,"targetDuration":123,"studyType":160,"phases":161,"briefSummary":163,"conditions":164,"keywords":123,"overallStatus":127,"whyStopped":123,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":180},{"fullName":5,"class":6},"Ohio State University Comprehensive Cancer Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment (anti-GARP CAR T cell)","EXPERIMENTAL","Patients undergo apheresis on day -14 and undergo surgery and placement of CSF reservoir on day 0. Patients receive anti-GARP CAR T intracavitary infusion on day 14, 21, 28, 35 and 42 in the absence of disease progression or unacceptable toxicities. Additionally, patients undergo ECHO or MUGA at screening and collection of CSF and blood samples, lumbar puncture, chest x-ray and MRI throughout the study.",[13,14,15,16,17,18,19,20],"Biological: Anti-GARP Chimeric Antigen Receptor-T Cells","Procedure: Biospecimen Collection","Procedure: Chest Radiography","Procedure: Echocardiography Test","Procedure: Magnetic Resonance Imaging","Procedure: Multigated Acquisition Scan","Procedure: Pheresis","Procedure: Surgical Procedure",[22,31,40,46,53,73,91,101],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"BIOLOGICAL","Anti-GARP Chimeric Antigen Receptor-T Cells","Given intracavitary",[9],[28,29,30],"Anti-GARP CAR T Cells (SY)","Anti-GARP CAR T-cells (SY)","Anti-GARP CAR-T Cells (SY)",{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"PROCEDURE","Biospecimen Collection","Undergo collection of CSF and blood samples",[9],[37,38,39],"Biological Sample Collection","Biospecimen Collected","Specimen Collection",{"type":32,"name":41,"description":42,"armGroupLabels":43,"otherNames":44},"Chest Radiography","Undergo chest x-ray",[9],[45],"Chest X-ray",{"type":32,"name":47,"description":48,"armGroupLabels":49,"otherNames":50},"Echocardiography Test","Undergo ECHO",[9],[51,52],"EC","Echocardiography",{"type":32,"name":54,"description":55,"armGroupLabels":56,"otherNames":57},"Magnetic Resonance Imaging","Undergo MRI",[9],[58,59,60,61,62,63,64,65,66,67,68,69,70,71,72],"Magnetic Resonance","Magnetic Resonance Imaging (MRI)","Magnetic resonance imaging (procedure)","Magnetic Resonance Imaging Scan","Medical Imaging, Magnetic Resonance \u002F Nuclear Magnetic Resonance","MR","MR Imaging","MRI","MRI Scan","MRIs","NMR Imaging","NMRI","Nuclear Magnetic Resonance Imaging","sMRI","Structural MRI",{"type":32,"name":74,"description":75,"armGroupLabels":76,"otherNames":77},"Multigated Acquisition Scan","Undergo MUGA",[9],[78,79,80,81,82,83,84,85,86,87,88,89,90],"Blood Pool Scan","Equilibrium Radionuclide Angiography","Gated Blood Pool Imaging","Gated Heart Pool Scan","MUGA","MUGA Scan","Multi-Gated Acquisition Scan","Radionuclide Ventriculogram Scan","Radionuclide Ventriculography","RNV Scan","RNVG","SYMA Scanning","Synchronized Multigated Acquisition Scanning",{"type":32,"name":92,"description":93,"armGroupLabels":94,"otherNames":95},"Pheresis","Undergo apheresis",[9],[96,97,98,99,100],"Apheresed","Apheresis","Blood Component Removal","Collection, Apheresis\u002FLeukapheresis","Hemapheresis",{"type":32,"name":102,"description":103,"armGroupLabels":104,"otherNames":105},"Surgical Procedure","Undergo surgery and placement of CSF reservoir",[9],[106,107,108,109,110,111,112,113,114],"Operation","Surgery","Surgery Type","Surgery, NOS","Surgical","Surgical Intervention","Surgical Interventions","Surgical Procedures","Type of Surgery",[116],{"name":117,"affiliation":5,"role":118},"James B Elder, MD","PRINCIPAL_INVESTIGATOR",[120],{"name":5,"role":121,"phone":122,"phoneExt":123,"email":124},"CONTACT","800-293-5066",null,"OSUCCCclinicaltrials@osumc.edu",[126],{"facility":5,"status":127,"city":128,"state":129,"zip":130,"country":131,"countryCode":132,"cosmosGeoPoint":133,"geoPoint":138,"contacts":139},"RECRUITING","Columbus","Ohio","43210","United States","US",{"type":134,"coordinates":135},"Point",[136,137],-82.99879,39.96118,{"lat":137,"lon":136},[140,144],{"name":141,"role":121,"phone":142,"phoneExt":123,"email":143},"James B. Elder, MD","614-685-1965","brad.elder@osumc.edu",{"name":141,"role":118,"phone":123,"phoneExt":123,"email":123},{"type":118,"investigatorFullName":146,"investigatorTitle":147,"investigatorAffiliation":5,"oldNameTitle":123,"oldOrganization":123},"James Elder","Principal Investigator","100590232","phase-1-anti-garp-chimeric-antigen-receptor-t-cell-therapy-for-the-treatment-of-recurrent-grade-iii-or-iv-gliomas-100590232",false,"NCT06964737","Anti-GARP Chimeric Antigen Receptor T Cell Therapy for the Treatment of Recurrent Grade III or IV Gliomas","A Phase I, Dose-Escalation Trial of Anti-GARP Chimeric Antigen Receptor-T Cell Therapy in Patients With Recurrent High-Grade Glioma Treated at a Single Medical Center","Inclusion Criteria:\n\n* Patients are ≥ 18 years old\n* Capacity to understand and willingness to provide written informed consent\n* Diagnosis or clinical suspicion of recurrent malignant glioma, including:\n\n  * History of high-grade glioma (World Health Organization \\[WHO\\] grade III or IV), or\n  * Prior, histologically-confirmed diagnosis of grade II glioma with new radiographic findings consistent with a high-grade glioma\n* Imaging and\u002For histopathological confirmation of recurrent disease, or verification of \"high risk\" histology confirmed by a biopsy with measurable disease by the Radiologic Assessment in Neuro-Oncology (RANO) criteria\n* Patient has unifocal disease in one hemisphere and is supratentorial. Lesion and edema can not be located in eloquent locations (e.g., brainstem, pre-\u002Fpost-central gyrus, visual cortex) or within 2 gyri of motor strip.\n* If on steroids such as dexamethasone, must be on a low dose (≤ 4mg per day) at the time of treatment, and not at an ascending dosage schedule at time of enrollment\u002Fleukapheresis\n\n  * Prior to apheresis and treatment 1 a 2- week washout should be observed\n* Subjects must not have received bevacizumab therapy and are not planned to start such therapy\n* Karnofsky performance score (KPS) ≥ 60\n* Subject is a surgical candidate for surgery for malignant glioma with the intent of resecting \\>80-90% of the tumor as the ideal treatment option\n* White blood cells (WBC) \\> 4,000 cells\u002FuL\n* Hemoglobin (Hgb) \\> 7 gm\u002FdL\n* Platelets (Plt) \\> 100\u002FdL\n* Serum creatinine ≤ 1.5 x institutional upper limit of normal\n* Liver function tests within 1.5 x institutional upper limit of normal\n* Women of reproductive potential must have a negative pregnancy test within 7 days of study start. All patients of reproductive potential must use a physician-approved contraceptive and refrain from sperm donation for at least two weeks prior, during, and six months after final T cell infusion. Women must refrain from breastfeeding for six months after final T cell infusion\n* Sufficient venous access, to be confirmed prior to apheresis\n* Life expectancy of greater than 12 weeks\n* PI clinical judgement of patients who will likely complete the trial and are able to maintain stable neurologic symptoms during intervention period\n\nExclusion Criteria:\n\n* Patients who have a history of malignancy other than the glioma under investigation in this study, except patients with the following malignancies\u002Ftreatment characteristics, who are eligible at the investigator's discretion:\n\n  * Patients with a history of malignancy that has been treated with curative intent at least 2 years prior to screening and with no evidence of relapse, if no concurrent anti-cancer therapy (except hormonal therapy) is being given\n  * Patients with a history of malignancy with a negligible risk of metastasis or death (e.g., 5-year OS rate \\> 90%) such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or stage I uterine cancer\n  * Patients who have prostate cancer with no evidence of metastatic disease and are not on active therapy, except anti-androgen therapy\n* History of autoimmune disease, or other diseases require long-term administration of high-dose steroids \\[\\> 10 mgs\u002Fday\\] or immunosuppressive therapies\n\n  * Research participants who received steroids must have either received their last dose of steroids 7 days or more prior to apheresis or have dosage tapered to \\\u003C 2mg\u002Fkg\u002Fday\n* Patients being treated concurrently (within 14 days prior to study enrollment) with any other investigational agent\n\n  * Examples of other investigational agents that would be exclusionary include supportive care agents\n* Patients receiving anti-cancer agents such as chemotherapy (e.g., temozolomide) must stop treatment 14 days prior to undergoing apheresis and remain off therapy throughout the duration of CAR T therapeutic intervention\n* Patients with active fungal, bacterial, viral, or other infection that requires intravenous antimicrobials\n\n  * Prophylactic antimicrobials are allowed\n  * Patients with active invasive fungal infection should be excluded even if the treatment is oral antimicrobials\n* History of allergy to study products\u002Fdiluents\u002Femulsions\n* Recent history (within last 3 months) of uncontrolled seizures","ALL","18 Years",{"count":158,"type":159},30,"ESTIMATED","INTERVENTIONAL",[162],"PHASE1","This phase I trial tests the safety, side effects, and best dose of anti-glycoprotein-A repetitions predominant (GARP) chimeric antigen receptor (CAR) T cell therapy and how well it works in treating patients with grade III or IV gliomas that have come back after a period of improvement (recurrent). CAR T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack tumor cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein, such as GARP, on the patient's tumor cells is added to the T cells in the laboratory. The special receptor is called a CAR. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain tumors. Giving anti-GARP CAR T cell therapy may be safe, tolerable, and\u002For effective in treating patients with recurrent grade III or IV gliomas.",[165,166,167,168,169,170],"Recurrent Malignant Glioma","Recurrent WHO Grade 3 Glioma","Recurrent WHO Grade 4 Glioma","WHO Grade 2 Glioma","WHO Grade 3 Glioma","WHO Grade 4 Glioma","2026-05-04",{"date":173,"type":174},"2026-05-08","ACTUAL",{"date":176,"type":174},"2025-05-21",{"date":178,"type":159},"2027-05-31",{"name":5,"class":6},1]