[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-who-grade-4-glioma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-who-grade-4-glioma":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,43,66,92,112],{"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":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100505282","phase-2-testing-the-anti-cancer-drug-erdafitinib-for-brain-cancers-that-have-returned-or-progressed-following-treatment-100505282",false,"NCT05859334","Testing the Anti-cancer Drug Erdafitinib for Brain Cancers That Have Returned or Progressed Following Treatment","A Phase 2 Study of Erdafitinib in Patients With Recurrent or Progressive IDH-Wild Type Glioma With an FGFR-TACC Gene Fusion","Inclusion Criteria:\n\n* Patient must be \\>= 18 years of age\n* Patient must have histologically confirmed IDH-WT gliomas (grade 2-4) as per World Health Organization (WHO) 2016 or 2021 classification\n* Tumor tissue should be positive for FGFR-TACC gene fusion as per any local next generation sequencing (NGS) (Clinical Laboratory Improvement Act \\[CLIA\\]-approved) assay described in background section\n* The disease should be recurrent or progressive glioma after initial anti-tumor treatment with at least 1 line of treatment including surgical resection, radiation therapy and\u002For chemotherapy\n* For patients with WHO grade 3 or 4 glioma and progressive disease \\\u003C 12 weeks after completion of chemoradiotherapy, progression can be defined by the following set of criteria:\n\n  * New enhancement outside of the radiation field (beyond the high-dose region or 80% isodose line)\n  * If there is unequivocal evidence of viable tumor on histopathologic sampling (e.g., solid tumor areas. i.e., \\> 70% tumor cell nuclei in areas), high or progressive increase in Ki-67 proliferation index compared with prior biopsy, or evidence for histologic progression or increased anaplasia in tumor)\n* For patients with WHO grade 3 or 4 glioma and progressive disease \\>= 12 weeks after completion of chemoradiotherapy, progression can be defined by the following set of criteria:\n\n  * New contrast-enhancing lesion outside of radiation field on decreasing, stable, or increasing doses of corticosteroids\n  * Increase by \\>= 25% in the sum of the products of perpendicular diameters between the first post-radiotherapy scan, or a subsequent scan with smaller tumor size, and the scan at 12 weeks or later on stable or increasing doses of corticosteroids\n  * For patients receiving antiangiogenic therapy, significant increase in T2\u002Ffluid attenuated inversion recovery (FLAIR) non-enhancing lesion may also be considered progressive disease. The increased T2\u002FFLAIR must have occurred with the patient on stable or increasing doses of corticosteroids compared with baseline scan or best response after initiation of therapy and not be a result of comorbid events (e.g., effects of radiation therapy, demyelination, ischemic injury, infection, seizures, postoperative changes, or other treatment effects)\n* For patients with WHO grade 2 glioma progression is defined by any one of the following:\n\n  * Development of new lesions or increase of enhancement (radiological evidence of malignant transformation)\n  * A 25% increase of the T2 or FLAIR non-enhancing lesion on stable or increasing doses of corticosteroids compared with baseline scan or best response after initiation of therapy, not attributable to radiation effect or to comorbid events\n* There must be measurable disease (enhancing or non-enhancing as per Response Assessment in Neuro-Oncology \\[RANO\\] or RANO-low-grade glioma \\[LGG\\] criteria), as evaluated on pre-treatment MRI\n* Patient understands the procedures and investigational nature of the study drug and agrees to comply with study requirements by providing written informed consent\n* Patient must have Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2 (or Karnofsky \\>= 60%)\n* Absolute neutrophil count \\>= 1000\u002FuL\n* Hemoglobin \\> 8 g\u002FdL (Patients are allowed to be transfused to this level)\n* Platelets \\>= 100 x 10\\^9\u002FL\n* Serum total bilirubin =\\\u003C 1.5 x upper limit of normal (ULN), unless considered due to Gilbert's disease or disease involvement following approval by the medical monitor\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) =\\\u003C 3 x institutional ULN\n* Creatinine clearance \\> 30 mL\u002Fmin (patients with mild or moderate renal impairment) based on the Cockroft-Gault glomerular filtration rate (GFR) estimation\n* Patient must have normal serum phosphate level as per local laboratory parameters. (Medical management allowed)\n* Patient must be recovered from any clinically relevant toxic effects of any prior surgery, radiotherapy, or chemotherapy treatment with temozolomide\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* Patients should be New York Heart Association Functional Classification class 2B or better\n* The effects of erdafitinib on the developing human fetus are unknown. For this reason and because FGFR inhibitors are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and one month after completion of erdafitinib administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and one month after completion of erdafitinib administration\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants\n\nExclusion Criteria:\n\n* Patients who are receiving any other investigational agents\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to erdafitinib\n* Patients requiring any medications or substances that are moderate CYP2C9 inducers and strong CYP3A4 inducers are ineligible. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated medical reference. As part of the enrollment\u002Finformed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product\n* Patients with uncontrolled intercurrent illness\n* Pregnant women are excluded from this study because erdafitinib is an FGFR inhibitor agent with the 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 erdafitinib, breastfeeding should be discontinued if the mother is treated with erdafitinib\n* Current central serous retinopathy (CSR) or retinal pigment epithelial detachment of any grade\n* Corrected QT interval (QTc) prolongation as confirmed by electrocardiography (ECG) at screening (Fridericia; QTc \\> 480 milliseconds)\n* Patients who have previously received FGFR inhibitors","ALL","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This phase II trial tests how well erdafitinib works in controlling IDH-wild type (WT), FGFR-TACC gene fusion positive gliomas that have come back after a period of improvement (recurrent) or that are growing, spreading, or getting worse (progressive). Erdafitinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal FGFR protein that signals tumor cells to multiply. This may help keep tumor cells from growing and may kill them. Giving erdafitinib may help to slow the growth of, or to shrink, tumor cells in patients with recurrent or progressive IDH-wild type gliomas with FGFR-TACC gene fusion.",[26,27,28,29],"Recurrent Glioma","Recurrent WHO Grade 2 Glioma","Recurrent WHO Grade 3 Glioma","Recurrent WHO Grade 4 Glioma","RECRUITING","2026-06-16",{"date":33,"type":34},"2026-06-17","ACTUAL",{"date":36,"type":34},"2024-01-04",{"date":38,"type":20},"2026-10-23",{"name":40,"class":41},"National Cancer Institute (NCI)","NIH",27,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":57,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":4},"100625417","phase-1-testing-the-combination-of-anti-cancer-drugs-actimab-a-and-cemiplimab-regn2810-to-improve-outcomes-for-patients-with-recurrent-glioblastoma-100625417","NCT07422363","Testing the Combination of Anti-cancer Drugs Actimab-A and Cemiplimab (REGN2810) to Improve Outcomes for Patients With Recurrent Glioblastoma","A Phase I Trial of 225Ac-anti-CD33 and PD1-Inhibitor in Recurrent Glioblastoma","Inclusion Criteria:\n\n* Patients must have histologically or cytologically confirmed glioblastoma isocitrate dehydrogenase wild type (IDH-WT) World Health Organization (WHO) grade 4 inclusive of gliosarcoma (Louis et al., 2021)\n\n  * Note: Isocitrate dehydrogenase (IDH) status confirmed by immunohistochemistry (IHC) for IDH1 R132H + next-generation sequencing (NGS) for IDH1 and IDH2 hotspots\n* Evidence of recurrent disease (RD) that is measurable (1 x 1cm) at first or second relapse demonstrated by disease progression using Response Assessment in Neuro-Oncology 2.0 (RANO 2.0) criteria, unless the recurrence is outside the radiation field or has been histologically documented\n* Tumor O-6-methylguanine-deoxyribonucleic acid (DNA) methyltransferase (MGMT) methylation status must be available from any prior GBM tumor specimen; results of routinely used methods for MGMT methylation testing (e.g., mutagenically separated polymerase chain reaction \\[MSPCR\\] or quantitative polymerase chain reaction \\[PCR\\] are acceptable)\n* Previous first-line treatment with at least radiotherapy (prior dose ≥ 40 gray \\[Gy\\])\n\n  * Note: Prior temozolomide, prior tumor-treatment fields and\u002For Gliadel wafer (if placed at initial tumor resection) are allowed, but none of these are required\n* Last radiation ≥ 6 months (182 days) prior to enrollment if received ≥ 60 Gy or ≥ 3 months (84 days) if received \\\u003C 60 Gy to limit the risk of radiation necrosis\n* No previous treatment with anti PD1, PDL1, CTLA-4, or other immune checkpoint inhibitors\n* No tumor-directed therapy for most recent progression\n* Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of Actimab-A in combination with cemiplimab (REGN2810) in patients \\\u003C 18 years of age, children are excluded from this study\n* Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)\n* Absolute neutrophil count ≥ 1,500\u002FmcL\n* Platelets ≥ 100,000\u002FmcL\n* Hemoglobin ≥ 9 g\u002FdL\n* Total bilirubin ≤ 1.5 institutional upper limit of normal (ULN) (however, patients with known Gilbert disease who have serum bilirubin level ≤ 3 x ULN may be enrolled)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3 × institutional ULN\n* Glomerular filtration rate (GFR) ≥ 60 mL\u002Fmin\u002F1.73 m\\^2\n* Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within six (6) months are eligible for this trial\n* For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load\n* 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 for this trial\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 II or better\n* The effects of Actimab-A and cemiplimab (REGN2810) on the developing human fetus are unknown. For this reason and because anti-PD-1 agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for at least six (6) months after completion of Actimab-A. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and six (6) months after completion of Actimab-A and cemiplimab (REGN2810) administration\n* Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives (LAR) may sign and give informed consent on behalf of study participants\n\nExclusion Criteria:\n\n* Patients who have not recovered to grade 0 or 1 or pre-treatment baseline from adverse events due to prior anti-cancer therapy (i.e., have residual toxicities \\> grade 1) with the exception of alopecia\n* Patients who are receiving any other investigational agents\n* Presence of extracranial metastatic or leptomeningeal disease\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to Actimab-A and cemiplimab (REGN2810)\n* Patients being treated with systemic immunostimulatory agents (including, but not limited to, interferon \\[IFN\\]-α or interleukin \\[IL\\]-2) within four (4) weeks prior to cycle 1 day 1. The study principal investigator (PI) must be consulted if a patient was being treated with any antibody within four (4) half-lives of said antibody\n\nTreatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor-alpha \\[TNF-α\\] agents) within two (2) weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions:\n\n* Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study\n* Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study\n\n  * Patients with uncontrolled intercurrent illness or any other significant condition(s) that would make participation in this protocol unreasonably hazardous\n  * Pregnant women are excluded from this study because cemiplimab (REGN2810) is an anti-PD-1 agent with the 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 cemiplimab (REGN2810), breastfeeding should be discontinued if the mother is treated with cemiplimab (REGN2810). These potential risks also apply to Actimab-A\n  * Early disease progression prior to three (3) months from the completion of radiotherapy\n  * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy defined as dexamethasone \\> 2 mg\u002Fday or bioequivalent for at least three (3) consecutive days within two (2) weeks of start of study drug\n  * Has active autoimmune disease that has required systemic treatment in the past two (2) years\n  * Prior administration of a radiopharmaceutical unless 10 or more effective half-lives have elapsed before injection of Actimab-A (Ac225-lintuzumab)\n  * Previous treatment with bevacizumab for the treatment of glioblastoma with therapeutic intent, or with bevacizumab as supportive therapy (e.g., edema reduction) within six (6) weeks (42 days) of initiation of study treatment. This is approximately two (2) half-lives which is justified based on median time to rebound tumor progression following bevacizumab discontinuation (6.1 weeks), median time to clinical deterioration following bevacizumab discontinuation after disease progression from multiple studies indicating that washout periods longer than eight (8) weeks are unlikely to be tolerated, and perioperative outcome data after neoadjuvant bevacizumab demonstrating relative safety of surgical intervention at least four (4) weeks after bevacizumab discontinuation (Sener et al., 2024)\n  * Patients who are unable to take spironolactone or eplerenone due to intolerance, allergy, drug-drug interactions, or for any other reason",{"count":19,"type":20},[52],"PHASE1","This phase I trial studies the side effects and best dose of Actimab-A when given together with cemiplimab (REGN2810) in treating patients with glioblastomas that have come back after a period of improvement (recurrent). Actimab-A consists of the monoclonal antibody lintuzumab combined with the radioactive drug actinium Ac 225. Lintuzumab specifically binds to the cell surface antigen CD33 which is found on the glioblastoma cells and delivers the actinium Ac 225. This may allow the glioblastoma to be found and treated by Actimab-A. Immunotherapy with monoclonal antibodies, such as cemiplimab (REGN2810), may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving Actimab-A with cemiplimab (REGN2810) may be safe, tolerable and\u002For effective in treating recurrent glioblastoma.",[55,56,29],"Recurrent Glioblastoma, IDH-Wildtype","Recurrent Gliosarcoma","NOT_YET_RECRUITING","2026-06-11",{"date":60,"type":34},"2026-06-12",{"date":62,"type":20},"2026-12-04",{"date":64,"type":20},"2027-02-28",{"name":40,"class":41},{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":73,"targetDuration":4,"studyType":21,"phases":74,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":91},"100590232","phase-1-anti-garp-chimeric-antigen-receptor-t-cell-therapy-for-the-treatment-of-recurrent-grade-iii-or-iv-gliomas-100590232","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",{"count":19,"type":20},[52],"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.",[77,28,29,78,79,80],"Recurrent Malignant Glioma","WHO Grade 2 Glioma","WHO Grade 3 Glioma","WHO Grade 4 Glioma","2026-05-04",{"date":83,"type":34},"2026-05-08",{"date":85,"type":34},"2025-05-21",{"date":87,"type":20},"2027-05-31",{"name":89,"class":90},"Ohio State University Comprehensive Cancer Center","OTHER",1,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":21,"phases":100,"briefSummary":101,"conditions":102,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":91},"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},[52],"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.",[55,27,28,29],"2026-04-29",{"date":105,"type":34},"2026-05-01",{"date":107,"type":34},"2024-07-23",{"date":109,"type":20},"2030-05-12",{"name":111,"class":90},"Northwestern University",{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":4,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":21,"phases":121,"briefSummary":122,"conditions":123,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":134},"100528395","phase-2-retifanlimab-with-bevacizumab-and-hypofractionated-radiotherapy-for-the-treatment-of-recurrent-glioblastoma-100528395","NCT06160206","Retifanlimab with Bevacizumab and Hypofractionated Radiotherapy for the Treatment of Recurrent Glioblastoma","A Phase II Open Label, Randomized Study Testing the Efficacy of Retifanlimab in Combination with Bevacizumab and Hypofractionated Radiotherapy in Patients with Recurrent GBM","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Recurrent World Health Organization (WHO) grade IV glioblastoma. Note: Any number of recurrences are allowable. Glioblastoma (GBM) variants and molecular GBM are allowed\n* Candidates for radiotherapy\n* Prior use of bevacizumab is allowed as long as the last treatment is \\> 4 months prior to randomization\n* Dexamethasone dose ≤ 4mg daily at the time of randomization (higher dose of steroid for symptom control is allowed during the study)\n* Karnofsky performance status ≥ 60%\n* Measurable disease or non-measurable disease per Response Assessment in Neuro-Oncology (RANO) criteria\n* Absolute neutrophil count (ANC) ≥ 1,500\u002Fmm\\^3 (obtained ≤ 28 days prior to registration)\n\n  * NOTE: If your site laboratory reports use different units of measurement than what is required by the protocol eligibility requirements, please use the \"Lab Test Unit Conversion Worksheet\" available on the Academic and Community Cancer Research Untied (ACCRU) website under \"General Forms\"\n* Platelet count ≥ 100,000\u002Fmm\\^3 (obtained ≤ 28 days prior to registration)\n\n  * NOTE: If your site laboratory reports use different units of measurement than what is required by the protocol eligibility requirements, please use the \"Lab Test Unit Conversion Worksheet\" available on the ACCRU website under \"General Forms\"\n* Hemoglobin ≥ 9.0 g\u002FdL (obtained ≤ 28 days prior to registration)\n\n  * NOTE: If your site laboratory reports use different units of measurement than what is required by the protocol eligibility requirements, please use the \"Lab Test Unit Conversion Worksheet\" available on the ACCRU website under \"General Forms\"\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (obtained ≤ 28 days prior to registration)\n\n  * NOTE: If your site laboratory reports use different units of measurement than what is required by the protocol eligibility requirements, please use the \"Lab Test Unit Conversion Worksheet\" available on the ACCRU website under \"General Forms\"\n* Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x ULN (≤ 5 x ULN for patients with liver involvement) (obtained ≤ 28 days prior to registration)\n\n  * NOTE: If your site laboratory reports use different units of measurement than what is required by the protocol eligibility requirements, please use the \"Lab Test Unit Conversion Worksheet\" available on the ACCRU website under \"General Forms\"\n* Creatinine ≤ 1.5 x ULN (obtained ≤ 28 days prior to registration)\n\n  * NOTE: If your site laboratory reports use different units of measurement than what is required by the protocol eligibility requirements, please use the \"Lab Test Unit Conversion Worksheet\" available on the ACCRU website under \"General Forms\"\n* Negative pregnancy test done ≤ 14 days prior to registration for women of childbearing potential only. (Pregnancy test can be urine or serum.)\n\n  * NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n  * A female of childbearing potential is a sexually mature female who:\n\n    * 1\\) Has not undergone a hysterectomy or bilateral hysterectomy; or\n    * 2\\) Has not been naturally postmenopausal for at least 12 consecutive months (i.e. has had menses at any time in the preceding 12 consecutive months)\n* Provide informed written consent ≤ 28 days prior to registration\n* Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study, i.e., active treatment)\n* Willing to provide mandatory blood specimens for correlative research purposes\n\nExclusion Criteria:\n\n* Any of the following because this study involves an investigational agent whose genotoxic, mutagenic, and teratogenic effects on the developing fetus and newborn are unknown:\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential who are unwilling to employ adequate contraception (men and women)\n* Co-morbid systemic illness or other severe concurrent disease which, in the judgement of the investigator, would make the patient inappropriate for entry into the study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Receiving any other investigational agent which would be considered treatment for the primary neoplasm ≤ 2 weeks prior to registration\n* Active uncontrolled autoimmune disease or syndrome (i.e. moderate or severe rheumatoid arthritis, moderate or severe psoriasis, multiple sclerosis, active inflammatory bowel disease) that has required systemic treatment in the past 2 years (i.e. with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) or who are receiving systemic therapy for an autoimmune or inflammatory disease (i.e. with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment. Subjects are permitted to enroll if they have vitiligo, resolved childhood asthma\u002Fatopy, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger\n* Has a severe acute or chronic medical condition including immune colitis, inflammatory bowel disease (may be enrolled at the discretion of the principal investigator \\[PI\\]), immune pneumonitis, or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study\n* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to epacadostat, retifanlimab, bevacizumab, or other agents used in the study\n* Has had an allogeneic tissue\u002Fsolid organ transplant\n* Has uncontrolled human immunodeficiency virus (HIV) (HIV ½ antibodies). Well-controlled HIV is defined as CD4+ count \\> 300 cells, undetectable viral load, and receiving highly active antiretroviral therapy (HAART)\u002Fantiretroviral therapy (ART). Study specific HIV testing is not required for patients who do not have any prior history of HIV\n* Has uncontrolled active hepatitis B (HBV) (e.g., hepatitis B serum antigen \\[HBsAg\\] reactive or HBV dioxyribonucleic acid \\[DNA\\] detected by quant real time polymerase chain reaction \\[RT PCR\\]) or hepatitis C (e.g. hepatitis C serum antigen \\[HCsAg\\] reactive or hepatitis C virus \\[HCV\\] ribonucleic acid \\[RNA\\] \\[qualitative or quantitative\\] is detected)\n* Receipt of live attenuated vaccine within 30 days before the first dose of study treatment. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g. FluMist) are live attenuated vaccines and are not allowed",{"count":120,"type":20},134,[23],"This phase II trial tests how well retifanlimab with bevacizumab and hypofractionated radiotherapy, compared to bevacizumab and hypofractionated radiotherapy alone, works in treating patients with glioblastoma that has come back after a period of improvement (recurrent). A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as retifanlimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Giving retifanlimab with bevacizumab and hypofractionated radiotherapy may work better in treating patients with recurrent glioblastoma than bevacizumab and hypofractionated radiotherapy alone.",[124,29],"Recurrent Glioblastoma","2024-11-14",{"date":127,"type":34},"2024-11-19",{"date":129,"type":34},"2024-10-02",{"date":131,"type":20},"2030-11-30",{"name":133,"class":90},"Academic and Community Cancer Research United",3]