[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-who-grade-3-glioma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-who-grade-3-glioma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,45],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"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":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"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.",[26,27,28,29,30,31],"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","RECRUITING","2026-05-04",{"date":35,"type":36},"2026-05-08","ACTUAL",{"date":38,"type":36},"2025-05-21",{"date":40,"type":20},"2027-05-31",{"name":42,"class":43},"Ohio State University Comprehensive Cancer Center","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":53,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":44},"100547613","phase-1-triapine-in-combination-with-temozolomide-for-the-treatment-of-patients-with-recurrent-glioblastoma-100547613","NCT06410248","Triapine in Combination With Temozolomide for the Treatment of Patients With Recurrent Glioblastoma","A Phase 1 Adaptive Dose Escalation With Dose Expansion Study of Triapine in Combination With Temozolomide (TMZ) for Patients With Recurrent Glioblastoma","Inclusion Criteria:\n\n* Patients must have histologically confirmed World Health Organization (WHO) grade 2-4 glioma, isocitrate dehydrogenase (IDH) wild type (WT) (by immunohistochemistry \\[IHC\\] R132H negative \\[neg\\] or sequencing). Astrocytoma with molecular features of glioblastoma (GBM). Confirmed diagnosis via molecular testing\n* Patients must have an established diagnosis of recurrent glioblastoma and:\n\n  * Group 1 and 2: recurrent glioblastoma\n  * Group 3: Surgically amenable recurrent glioblastoma\n* Patients must have stable or decreasing dose of corticosteroids equivalent to ≤ 6 mg dexamethasone, for ≥ 7 days prior to registration\n* Patients with disease that has progressed after a standard or investigational first-line therapy (e.g. radiotherapy \\[RT\\], RT plus temozolomide) with or without tumor treating fields therapy (TTFields)\n\n  * Note: Patients who have received fractionated first-line radiation therapy and no prior chemotherapy (e.g. as common practice for MGMT unmethylated tumors), or who have participated in an investigational protocol substituting TMZ for a novel agent are eligible\n* Patients must be able to undergo contrast-enhanced magnetic resonance imaging (MRI)\n* Patients must be age ≥ 18 years\n* Patients must exhibit a Karnofsky performance status ≥ 70\n* Leukocytes (white blood cells \\[WBC\\]) ≥ 3,000\u002FmcL\n* Absolute neutrophil count (ANC) ≥ 1,500\u002FmcL\n* Hemoglobin (Hgb) ≥ 8 g\u002FdL (transfusion may be used for eligibility outside of 7 days)\n* Platelets (PLT) ≥ 100,000\u002FmcL (transfusion or growth factor may be used for eligibility outside of 7 days)\n* Total bilirubin ≤ 2 x institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) ≤ 3 x institutional ULN\n* Creatinine ≤ 1.5 x institutional ULN\n* International normalized ratio (INR) ≤ 1.5 x ULN\n* Prothrombin time (PT)\u002Fpartial thromboplastin time (PTT) ≤ 1.5 x ULN\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better\n* Patients of child-bearing potential (POCBP) must agree to use two forms of adequate contraception (hormonal or barrier method of birth control, abstinence) from time of informed consent and for the duration of study participation. Patients who can impregnate their partners must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) from time of informed consent and for the duration of study participation\n\n  * Should a patient become pregnant or suspect they are pregnant while they or their partner is participating in this study, they should inform their treating physician immediately.\n  * Note: At the discretion of the investigator, acceptable methods of contraception may include total abstinence in cases where the lifestyle of the patient ensures compliance. (Periodic abstinence \\[e.g., calendar, ovulation, symptothermal, postovulation methods\\] and withdrawal are not acceptable methods of contraception.)\n  * Note: A POCBP is any person with an egg-producing reproductive tract (regardless of gender, sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\n\n    * Has not undergone a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy\n    * Has had menses at any time in the preceding 12 consecutive months (and therefore has not been naturally postmenopausal for \\> 12 months) (in patients \\> 45 years of age in the absence of other biological or physiological causes)\n\n      * Potential POCBP who may be menopausal and are \\\u003C 55 years of age must have a serum follicle-stimulating hormone (FSH) level \\> 40 mIU\u002FmL to confirm menopause\n      * Note: Documentation may include review of medical records, medical examination, or medical history interview by study site staff\n* Patient must be willing and able to comply with the protocol for the duration of the study and provide written, signed, and dated informed consent prior to study registration.\n\n  * NOTE: No study-specific screening procedures may be performed until written consent has been obtained\n* Patients must have the ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Patients who have a prior or concurrent malignancy that may interfere with study treatment or safety\n\n  * NOTE: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible, per principal investigator (PI) discretion\n* Patients who are receiving any other investigational agents.\n\n  * Exceptions: COVID-19 vaccine and treatment is allowed, per PI's discretion\n* Patient's interval since last cytotoxic therapy ≥ 1 cycle or ≥ 2 biological half-lives, i.e.\n\n  * ≥ 28 days since start of last cycle of temozolomide (cycle length-28 days)\n  * ≥ 42 days since start of last cycle of lomustine or other nitrosourea (cycle length-42 days)\n  * ≥ 21 days since start of last cycle of a small molecule targeted agent (cycle length-21 days)\n  * ≥ 42 days from last bevacizumab infusion (cycle length-42 days)\n* Patients who have a history of allergic reactions attributed to compounds of similar chemical composition to temozolomide or triapine\n* Patients with spinal cord and diffuse leptomeningeal dissemination\n* Patients with a history of G6PD deficiency or other congenital or autoimmune hemolytic disorders. All participants will be screened for G6PD levels prior to registration\n* Patients who have an uncontrolled intercurrent illness including, but not limited to any of the following:\n\n  * Have uncontrolled epilepsy\n  * Have an uncontrolled intercurrent illness\n  * Are pregnant or nursing\n  * Concurrent malignancy (outside of glioblastoma) that requires tumor directed treatment\n  * Known concurrent shingles, herpes, cytomegalovirus (CMV) infection\n  * Known concurrent opportunistic fungal infection\n  * Known immunodeficiency that could lead to opportunistic infections\n  * Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n  * Any other illness or condition that the treating investigator feels would interfere with study compliance or would compromise the patient's safety or study endpoints\n* Patients who are pregnant or nursing. Pregnant patients are excluded from this study because temozolomide is an alkylating agent with potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with temozolomide, breastfeeding should be discontinued if the mother is treated with temozolomide\n* Patients who are unable to swallow oral medication or have problems\u002Fdiseases that affect absorption or oral medication\n* Patients with a known history of human immunodeficiency virus (HIV), hepatitis B virus (HBV), and\u002For hepatitis C virus (HCV). If patient does not have a known history testing will not be conducted\n\n  * Note: Temozolomide is an immunosuppressive agent. Patients with a known history of HIV, HBV, and HCV, and unexplained opportunistic infections are not eligible due to safety reasons",{"count":19,"type":20},[23],"This phase I trial tests the safety, side effects, and best dose of triapine in combination with temozolomide in treating patients with glioblastoma that has come back after a period of improvement (recurrent). Triapine inhibits an enzyme responsible for producing molecules required for the production of deoxyribonucleic acid (DNA), which may inhibit tumor cell growth. Temozolomide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill tumor cells and slow down or stop tumor growth. Giving triapine in combination with temozolomide may be safe, tolerable, and\u002For effective in treating patients with recurrent glioblastoma.",[56,57,27,28],"Recurrent Glioblastoma, IDH-Wildtype","Recurrent WHO Grade 2 Glioma","2026-04-29",{"date":60,"type":36},"2026-05-01",{"date":62,"type":36},"2024-07-23",{"date":64,"type":20},"2030-05-12",{"name":66,"class":43},"Northwestern University"]