[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-glioblastoma-idh-wildtype\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-glioblastoma-idh-wildtype":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,46,82,106,128,148,170,192,218,238,261,284,305],{"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":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100582229","phase-1-testing-the-addition-of-an-anti-cancer-drug-triapine-to-the-usual-radiation-therapy-for-recurrent-glioblastoma-or-astrocytoma-100582229",false,"NCT06860594","Testing the Addition of an Anti-Cancer Drug, Triapine, to the Usual Radiation Therapy for Recurrent Glioblastoma or Astrocytoma","A Phase I Trial Combining Triapine With Radiation Therapy for Recurrent Glioblastoma or Astrocytoma","Inclusion Criteria:\n\n* Patients must have histologically, molecularly, or cytologically confirmed recurrent astrocytic tumors including:\n\n  * GBM or variants, IDH-wildtype, grade 2-4 (standard curative measures available or not)\n  * Astrocytoma, IDH-mutant, grade 2-4 (standard curative measures available or not)\n  * Diffuse midline gliomas, including pediatric-type H3 G34 or E3 K27 mutant tumors.\n* Tumors ≤ 6 cm in maximal diameter.\n\n  * Patients who had recent resection for recurrent tumor must have measurable disease.\n* Patients must have at least a 6-month break from last dose of radiation therapy.\n\nRe-irradiation within 6 months may increase risk for radiation necrosis\u002Fedema, which will affect toxicity assessment and patient safety. Additionally, GBM and other high-grade astrocytic tumors can exhibit pseudo-progression within 6 months from completing definitive, 1st line radiation therapy, and re-irradiation during this period will increase risk for misattribution of effect.\n\n* Prior history of standard dose radiation for gliomas of 59.4-60 gray (Gy) in 1.8-2 Gy per fraction (or equivalent or lower) is allowed.\n* Patients who received non-standard radiation dose regimen (e.g., 40 Gy, 34-35 Gy, 25 Gy) or stereotactic radiosurgery are eligible as long as there is at least one of the following:\n\n  * A new tumor outside the original radiotherapy field as determined by the investigator.\n  * There is histologic confirmation of tumor on biopsy or resection.\n  * Imaging findings are consistent with true progressive disease (on standard MRI sequences, MRI spectroscopy\u002Fperfusion, or nuclear medicine imaging).\n* Age ≥ 18 years. Because no dosing or adverse event data are currently available on the use of triapine 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* Hemoglobin ≥ 8 g\u002FdL.\n* Platelets ≥ 100,000\u002FmcL.\n* Total bilirubin ≤ 1.5 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 ULN OR glomerular filtration rate (GFR) ≥ 50 mL\u002Fmin\u002F1.73 m\\^2.\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 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* Patients must be able to swallow whole capsules.\n* Patients must be able to undergo MRIs with contrast. Patients with non-compatible devices with MRI can be eligible if CT scans of sufficient quality are obtained. However, patients without non-compatible devices may not use CT scans to meet this requirement.\n* The effects of triapine on the developing human fetus are unknown. For this reason and because ribonucleotide reductase (RNR) inhibitor agent and radiation 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 12 months after finishing study treatment. People of child-bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of human chorionic gonadotropin \\[HCG\\]) within 2 weeks of registration. 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 12 months after completion of triapine 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 have not recovered 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* Patients who are actively taking medications that are known to induce methemoglobinemia (e.g. sulfonamides, nitrofurans, anti-malarials \\[primaquine, chloroquine\\], cyclophosphamide, and ifosfamide).\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to triapine.\n* Patients with known G6PD deficiency. Testing for G6PD deficiency is not required.\n* Patients with uncontrolled intercurrent illness, active infections, or any other significant condition(s) that would make participation in this protocol unreasonably hazardous.\n* Pregnant women are excluded from this study because triapine is a RNR 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 triapine, breastfeeding should be discontinued if the mother is treated with triapine. These potential risks may also apply to the radiation used in this study.","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 triapine in combination with radiation therapy in treating patients with glioblastoma or astrocytoma that has come back after a period of improvement (recurrent). Triapine may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Giving triapine in combination with radiation therapy may be safe, tolerable, and\u002For effective in treating patients with recurrent glioblastoma or astrocytoma.",[26,27,28,29,30,31,32],"Astrocytoma, IDH-Mutant, Grade 2","Recurrent Adult Diffuse Hemispheric Glioma, H3 G34-Mutant","Recurrent Adult Diffuse Midline Glioma, H3 K27-Mutant","Recurrent Astrocytoma, IDH-Mutant","Recurrent Astrocytoma, IDH-Mutant, Grade 3","Recurrent Astrocytoma, IDH-Mutant, Grade 4","Recurrent Glioblastoma, IDH-Wildtype","RECRUITING","2026-06-27",{"date":36,"type":37},"2026-06-30","ACTUAL",{"date":39,"type":37},"2025-07-30",{"date":41,"type":20},"2027-06-30",{"name":43,"class":44},"National Cancer Institute (NCI)","NIH",43,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":58,"conditions":59,"keywords":64,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":81},"100642374","early-phase-1-dosimetry-safety-and-efficacy-study-of-177lulu-xt771-in-patients-with-recurrent-glioblastoma-100642374","NCT07648823","Dosimetry, Safety, and Efficacy Study of [177Lu]Lu-XT771 in Patients With Recurrent Glioblastoma","An Investigator-Initiated Trial to Evaluate the Dosimetry, Safety, Tolerability, and Preliminary Efficacy of a Single-Dose [177Lu]Lu-XT771 Injection in Patients With Recurrent Glioblastoma","Inclusion Criteria:\n\n1. Subject has fully understood the study and voluntarily signed the informed consent form.\n2. Age ≥ 18 and ≤ 80 years old.\n3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.\n4. Life expectancy of at least 3 months.\n5. Histologically confirmed glioblastoma (based on the 2021 WHO Classification of Tumors of the Central Nervous System, 5th edition), and confirmed CA IX\u002FCA XII positive by histology or \\[68Ga\\]Ga-XT771 PET\u002FCT.\n6. Histologically confirmed recurrence of glioblastoma following prior treatments.\n7. Suitable for Ommaya reservoir placement and meets the conditions for drug administration, as judged by the investigator.\n8. Tumor resection cavity volume between 2.5 and 25 cm\\^3.\n9. On a stable or decreasing dose of corticosteroids (≤5 mg\u002Fday of dexamethasone or equivalent) for at least 1 week prior to the first dose.\n10. Toxicity from prior anti-tumor treatments (e.g., chemotherapy, radiotherapy, immunotherapy) recovered to ≤ Grade 1 (excluding alopecia).\n11. Adequate organ and bone marrow function meeting the following criteria:\n\n    * Bone marrow: Absolute neutrophil count (ANC) ≥ 1.5 ×10\\^9\u002FL and white blood cell (WBC) count ≥ 3 ×10\\^9 \u002FL (without growth factor support within 28 days prior to dosing); Platelet count ≥ 75 ×10\\^9\u002FL; Hemoglobin ≥ 90 g\u002FL.\n    * Hepatic function: Total bilirubin ≤ 1.5 × ULN (≤ 2.0 × ULN for subjects with liver metastases; ≤ 3.0 × ULN for subjects with confirmed Gilbert's syndrome); ALT and AST ≤ 3 × ULN (\\\u003C 5 × ULN for subjects with liver metastases); Albumin \\> 30 g\u002FL.\n    * Renal function: Serum creatinine ≤ 1.5 × ULN and creatinine clearance rate ≥ 50 mL\u002Fmin.\n    * Coagulation: INR ≤ 2.0, APTT ≤ 1.5 × ULN. (Exception: subjects receiving warfarin may have an INR between 2 and 3 inclusive).\n12. Fertile subjects (and their partners) must agree to use highly effective contraceptive methods (e.g., condoms, oral or injectable contraceptives) during the treatment period and for 6 months after the last dose of the study drug.\n\nExclusion Criteria:\n\n1. Received anti-tumor treatments (including radiotherapy, chemotherapy, biological therapy, endocrine therapy, targeted therapy, etc.) within 4 weeks prior to dosing. Exceptions: (1) immunotherapy, nitrosoureas, or mitomycin C within 6 weeks prior to dosing; (2) oral fluorouracils and small molecule targeted drugs within 2 weeks or 5 half-lives (whichever is longer) prior to dosing; (3) Traditional Chinese Medicine with anti-tumor indication within 2 weeks prior to dosing; (4) cranial radiotherapy within 3 months prior to dosing.\n2. Received any other unapproved investigational drug within 4 weeks prior to dosing.\n3. Underwent major organ surgery (excluding needle biopsy) or experienced significant trauma within 4 weeks prior to dosing, or expected to require elective surgery during the study period.\n4. Known or suspected allergy to the study drug or its analogue components.\n5. Inability to undergo contrast-enhanced MRI scans (e.g., due to pacemakers, contrast agent allergy).\n6. Presence of active or uncontrolled infections requiring systemic intravenous treatment, or unexplained fever \\>38.5°C during the screening period or before dosing.\n7. Presence of severe coagulation disorders or evidence of significant bleeding risk; history of gastrointestinal bleeding; any Grade ≥2 bleeding event (CTCAE v5.0) within the past 6 months.\n8. Active Hepatitis B (HBsAg positive and HBV-DNA \\> 500 IU\u002FmL or above the lower limit of detection of the study center) or Active Hepatitis C (HCV antibody positive and HCV-RNA \\> the lower limit of detection of the study center).\n9. Uncontrolled hypertension as judged by the investigator (systolic blood pressure ≥ 160 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg despite standard treatment).\n10. History of severe cardiovascular disease, such as ventricular arrhythmias requiring clinical intervention; QTc interval \\> 480 ms; acute coronary syndrome, congestive heart failure, stroke, or other ≥ Grade III cardiovascular events within 6 months prior to dosing; NYHA class II-IV or LVEF \\\u003C 50%.\n11. History of other uncured malignancies within the past 3 years or concurrently, except for curable in situ cancers (e.g., carcinoma in situ of the cervix, basal cell carcinoma of the skin).\n12. Presence of two or more intracranial lesions, extracranial metastases, or tumors located in the infratentorial compartment or basal ganglia.\n13. Brain MRI indicating that the enhancing edge of the tumor invades the ventricular wall, or the surgical cavity communicates with the ventricle.\n14. Psychiatric disorders or poor compliance.\n15. Pregnant or lactating women.\n16. The investigator considers the subject unsuitable for participation in this clinical study due to other severe systemic diseases or other reasons.","80 Years",{"count":55,"type":20},5,[57],"EARLY_PHASE1","The primary objective of this study is to evaluate the dosimetry, safety, and tolerability of the investigational radiopharmaceutical \\[177Lu\\]Lu-XT771 in patients with recurrent glioblastoma, an aggressive form of brain cancer. \\[177Lu\\]Lu-XT771 is designed to specifically target and deliver beta radiation directly to tumor cells that overexpress carbonic anhydrase IX and XII (CA IX and CA XII).\n\nThis early-phase, investigator-initiated trial will enroll a small group of approximately 3-5 patients, each receiving a single dose of \\[177Lu\\]Lu-XT771. The drug will be administered locoregionally via an implanted Ommaya reservoir, directly into the tumor cavity. Following administration, patients will be closely monitored using single-photon emission computed tomography\u002Fcomputed tomography (SPECT\u002FCT) to assess the biodistribution of the drug and to quantify the absorbed radiation dose to both the tumor and normal organs.\n\nThe study will also document all adverse events to characterize the safety profile of the treatment and will provide a preliminary assessment of its anti-tumor activity, as measured by progression-free survival. The information gathered from this exploratory study will be used to determine the recommended safe starting dose for future Phase I clinical trials.",[60,61,62,63],"Recurrent Glioblastoma (WHO-Grade IV Glioma)","Recurrent Glioblastoma","Glioblastoma (GBM)","Recurrent Glioblastoma IDH Wildtype",[61,65,66,67,68,69,70],"[177Lu]Lu-XT771","Carbonic Anhydrase IX","Carbonic Anhydrase XII","Safety and Tolerability","Dosimetry","Efficacy","2026-06-13",{"date":73,"type":37},"2026-06-16",{"date":75,"type":20},"2026-06-20",{"date":77,"type":20},"2028-06-01",{"name":79,"class":80},"Beijing Tiantan Hospital","OTHER",2,{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":21,"phases":91,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":81},"100641259","early-phase-1-177lulu-dota-eb-rgd2-therapy-in-patients-with-recurrent-high-grade-glioma-100641259","NCT07655869","[177Lu]Lu-DOTA-EB-RGD2 Therapy in Patients With Recurrent High-grade Glioma","An Investigator-Initiated Clinical Trial to Evaluate the Safety, Tolerability, Dosimetry, and Preliminary Efficacy of [177Lu]Lu-DOTA-EB-RGD2 in Patients With Recurrent High-grade Glioma","Inclusion Criteria:\n\n1. The participant must sign the informed consent form before participation.\n2. Age ≥ 18 years.\n3. Histologically confirmed glioblastoma (WHO classification) after surgical resection or biopsy.\n4. Participants receiving corticosteroids (e.g., dexamethasone) must be on a stable or decreasing dose ≤ 4 mg\u002Fday (or equivalent) for at least 7 days before start of study treatment.\n5. Adequate bone marrow and organ function confirmed by laboratory tests performed ≤ 14 days before first study treatment:\n\n   Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL; Platelet count ≥ 100 × 10⁹\u002FL; Hemoglobin ≥ 10.0 g\u002FdL; Serum creatinine ≤ 1.5 × upper limit of normal (ULN); Total bilirubin ≤ 1.5 × ULN; albumin ≥ 30 g\u002FL; ALT and AST \\\u003C 3 × ULN in absence of liver metastases, or \\\u003C 5 × ULN if liver metastases present; Coagulation: activated partial thromboplastin time (APTT) ≤ 2 × ULN, international normalized ratio (INR) ≤ 1.5 (if not receiving anticoagulation therapy);\n6. Evidence of disease progression (PD) by RANO 2.0 criteria confirming recurrence: ≥ 25% increase in product of perpendicular diameters or \\> 40% increase in tumor volume compared to baseline after initial treatment or best response, while on stable or increasing corticosteroid dose. Clinical deterioration or increased corticosteroid dose alone is insufficient. MRI contrast enhancement, MRS, and\u002For metabolic PET should help differentiate true progression from radiation necrosis\u002Fpseudoprogression. Also, at least one bi-dimensionally measurable contrast-enhancing lesion with shortest diameter ≥ 10 mm must be present on MRI.\n7. For participants receiving Ommaya reservoir implantation for locoregional administration, surgery must be completed at least 2 weeks before first radionuclide therapy, with no postoperative complications. Baseline MRI for efficacy assessment must be performed at least 2 weeks after implantation and before first radionuclide therapy.\n8. Tumor uptake confirmed by NOTA-PRGD2 PET\u002FCT after diagnosis of recurrence and before radionuclide therapy. For participants with Ommaya reservoir, PET\u002FCT must be performed at least 2 weeks after implantation and before first radionuclide therapy.\n9. Life expectancy \\> 6 months.\n10. Karnofsky Performance Status (KPS) score ≥ 50.\n\nExclusion Criteria:\n\n1. Receiving any other concurrent treatment for glioblastoma outside this study.\n2. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed from the start of \\[177Lu\\]Lu-DOTA-EB-RGD2 treatment until 6 months after treatment.\n3. Refusal to use effective contraception during sexual intercourse from informed consent until 6 months after the last dose of study drug.\n4. Inability to tolerate imaging procedures, repeated blood sampling, or poor venous access.\n5. Cardiac dysfunction, clinically significant cardiac disease history, or ECG abnormalities indicating a major safety risk, including:\n\n(1) Documented myocardial infarction, angina pectoris, cardiomyopathy, symptomatic pericarditis, or coronary artery bypass grafting within 6 months before enrollment.\n\n(2) Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following: (a) risk factors for torsade de pointes (TdP) including uncorrected hypocalcemia, hypokalemia, hypomagnesemia, history of heart failure, or clinically significant\u002Fsymptomatic bradycardia; (b) use of medications known to prolong the QT interval and\u002For cause TdP that cannot be discontinued or replaced with a safer alternative (e.g., within 5 half-lives or 7 days before study drug); (c) inability to determine the Fridericia-corrected QT interval (QTcF).\n\n(3) Clinically significant arrhythmia (e.g., ventricular tachycardia), complete left bundle branch block, high-grade atrioventricular block (e.g., bifascicular block, Mobitz type II, third-degree AV block).\n\n(4) Resting QTcF ≥ 450 ms (male) or ≥ 460 ms (female). (5) Left ventricular ejection fraction (LVEF) \\\u003C 50% by echocardiography. (6) Uncontrolled hypertension defined as systolic blood pressure ≥ 160 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg, regardless of antihypertensive use.\n\n6\\. Other malignancy within 5 years before study drug administration, except adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer after curative surgery, carcinoma in situ after curative surgery, or papillary thyroid cancer after curative surgery (hormonal therapy for non-metastatic prostate or breast cancer allowed).\n\n7\\. Abnormal serum virology (HBsAg, T. pallidum antibody, HIV antibody, HCV antibody). Patients with untreated active hepatitis B who are willing to receive anti-HBV therapy during study treatment are allowed; patients with inactive hepatitis B are allowed; patients with inactive hepatitis C (HCV antibody positive but HCV RNA below lower limit of detection) are allowed.\n\n8\\. Use of bevacizumab for glioblastoma or supportive care (e.g., edema reduction) within 60 days before start of study treatment.\n\n9\\. Patients with disease progression within the first 12 weeks after completion of radiotherapy are excluded from recurrent disease trials.\n\n10\\. Prior intracranial locoregional drug therapy before \\[177Lu\\]Lu-DOTA-EB-RGD2 treatment.\n\n11\\. Active intracranial or intratumoral hemorrhage detected by CT\u002FMRI. 12. Seizure within 14 days before start of study treatment; epilepsy or increased intracranial pressure uncontrolled by medication.\n\n13\\. Grade 4 myelosuppression from prior anticancer therapy that has not recovered within 2 weeks, or grade 3 myelosuppression requiring \\>6 weeks to recover.\n\n14\\. Blood transfusion within 4 weeks before screening to meet eligibility criteria.\n\n15\\. Known hypersensitivity or delayed allergic reaction to any component of \\[177Lu\\]Lu-DOTA-EB-RGD2 or similar drugs.\n\n16\\. Severe disease of the cardiac, respiratory, central nervous system, renal, hepatic, or other organ systems that, in the investigator's opinion, may increase participant safety risk.\n\n17\\. Active infection requiring intravenous antibiotics (bacterial, fungal, or viral) within 4 weeks before first dose, or any other uncontrolled active infection deemed clinically significant by the investigator.\n\n18\\. History of drug or alcohol abuse within one year before screening, long-term drug use, or psychiatric illness that may affect compliance.\n\n19\\. Participation in another investigational drug or device trial within 4 weeks before first dose.",{"count":90,"type":20},24,[57],"This is an investigator-initiated, Phase I clinical trial. It aims to evaluate the safety, tolerability, dosimetry, and preliminary anti-tumor activity of a novel radiopharmaceutical, \\[177Lu\\]Lu-DOTA-EB-RGD2, in patients with recurrent high-grade gliomas. Participants will receive the drug either via intravenous infusion or directly into the tumor cavity through a pre-implanted Ommaya reservoir (a subcutaneously placed device that allows direct access to the tumor cavity). The study employs a \"3+3\" dose-escalation design to determine the maximum tolerated dose (MTD). Adverse events, biodistribution, and tumor response (by MRI) will be assessed. Approximately 24 patients will be enrolled across two major Chinese medical centers: Beijing Tiantan Hospital and Peking Union Medical College Hospital.",[94,63],"Recurrent High-Grade Gliomas",[94,96,97,68,98],"Integrin αvβ3","Targeted Radionuclide Therapy","Radiation Dosimetry",{"date":100,"type":37},"2026-06-18",{"date":102,"type":20},"2026-06-01",{"date":104,"type":20},"2027-01-31",{"name":79,"class":80},{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":21,"phases":114,"briefSummary":115,"conditions":116,"keywords":4,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"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},[23],"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.",[32,117,118],"Recurrent Gliosarcoma","Recurrent WHO Grade 4 Glioma","NOT_YET_RECRUITING","2026-06-11",{"date":122,"type":37},"2026-06-12",{"date":124,"type":20},"2026-12-04",{"date":126,"type":20},"2027-02-28",{"name":43,"class":44},{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":21,"phases":136,"briefSummary":137,"conditions":138,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":147},"100634846","phase-1-locoregional-administration-of-genetically-engineered-cells-egfril13r2-pool-car-t-cells-for-the-treatment-of-recurrent-or-progressive-high-grade-gliomas-100634846","NCT07544992","Locoregional Administration of Genetically Engineered Cells (EGFR\u002FIL13Rα2 Pool-CAR T Cells) for the Treatment of Recurrent or Progressive High-Grade Gliomas","A Phase 1 Trial to Evaluate the Safety of EGFR\u002FIL13Rα2 Pool-CAR T Cells in Patients With Recurrent or Progressive High-Grade Glioma (HGG)","Main Inclusion Criteria\n\n* Documented informed consent of the participant and\u002For legally authorized representative.\n* Agreement to allow the use of archival tissue from diagnostic tumor biopsies. If unavailable, exceptions may be granted with Study PI approval.\n* Age 18 years and older.\n* KPS ≥ 70%, ECOG ≤ 2 (Appendix A).\n* Life expectancy ≥ 4 weeks.\n* Participant has a prior histologically confirmed diagnosis of a glioblastoma (IDH-wildtype) or grade 4 IDH-mutant astrocytoma, or has a prior histologically confirmed diagnosis of a grade 2 or 3 astrocytoma and now has radiographic progression consistent with grade 4 IDH-mutant astrocytoma.\n* Relapsed disease: radiographic evidence of recurrence\u002Fprogression of measurable disease after standard therapy (such as temozolomide with or without Optune device), and ≥ 12 weeks after completion of front-line radiation therapy.\n* COH Clinical Pathology assessment at the initial tumor presentation or recurrent disease (reference Appendix B):\n\n  * IL13Rα2+ expression by IHC \\> 20, and\n  * EGFR gene-altered by NGS or FISH analysis\n* No known contraindications to leukapheresis, steroids, imaging studies, or tocilizumab.\n* WBC \\> 2000 \u002Fdl (or ANC ≥ 1,000\u002Fmm3)\n* Platelets ≥ 75,000\u002Fmm3\n* Hemoglobin \\> 9g\u002FdL\n* Total bilirubin ≤ 1.5x ULN\n* AST ≤ 2.5x ULN\n* ALT ≤ 2.5x ULN\n* Serum creatinine ≤1.6 mg\u002FdL\n* O2 saturation ≥ 95% on room air.\n* Seronegative for HIV Ag\u002FAb combo, HCV, and active HBV\n* Women of childbearing potential (WOCBP): negative urine or serum pregnancy test.\n* Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 3 months after the last dose of CAR T cells.\n\nMain Exclusion Criteria\n\n* Owing to higher frequency of wound-related complications, participants who require active bevacizumab therapy at the time of enrollment are excluded.\n* Participant has not yet recovered from toxicities of prior therapy.\n* Participant has received any live vaccine within 30 days prior to enrollment.\n* Uncontrolled seizure activity and\u002For clinically evident progressive encephalopathy.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent.\n* Clinically significant uncontrolled illness.\n* Active autoimmune disease requiring systemic immunosuppressive therapy\n* Active infection requiring IV antibiotics (for example, minor scalp infection is not exclusion).\n* Known history of immunodeficiency virus (HIV) or hepatitis B or hepatitis C infection.\n* Other active malignancy.\n* Females only: Pregnant or breastfeeding.\n* Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns with clinical study procedures.\n* Prospective participants who, in the opinion of the Investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility\u002Flogistics).",{"count":90,"type":20},[23],"This phase I trial studies the side effects and best dose of EGFR\u002FIL13Rα2 pool-chimeric antigen receptor (CAR) T cells when given through a thin, flexible tube into the brain (locoregional administration) in treating patients with high-grade gliomas that have come back after a period of improvement (recurrent) or that are growing, spreading, or getting worse (progressive). EGFR\u002FIL13Rα2 pool-CAR T cells are a type of CAR T cell therapy. 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 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 cancers.",[31,32],"2026-06-10",{"date":122,"type":37},{"date":142,"type":20},"2026-12-24",{"date":144,"type":20},"2031-11-04",{"name":146,"class":80},"City of Hope Medical Center",1,{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":4,"eligibilityCriteria":154,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":155,"targetDuration":4,"studyType":21,"phases":157,"briefSummary":159,"conditions":160,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":168,"locationsCount":169},"100472509","phase-1-testing-the-addition-of-an-anti-cancer-drug-selinexor-to-the-usual-chemotherapy-treatment-temozolomide-for-brain-tumors-that-have-returned-after-previous-treatment-100472509","NCT05432804","Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment","A Phase 1 and Randomized Phase 2 Trial of Selinexor and Temozolomide in Recurrent Glioblastoma","Inclusion Criteria:\n\n* Patients must have histologically confirmed glioblastoma (IDH wild-type, MGMT promoter methylated) that has undergone resection or biopsy upon first recurrence. Recurrence at site of prior involvement is defined by histopathological evidence of viable neoplastic cells associated with any of the following: mitotic activity, increased proliferation rate, micro-endothelial proliferation, or pseudo-palisading necrosis\n* Prior to resection or biopsy, patients must have measurable disease, defined as at least one bi-dimensional contrast-enhancing lesion with clearly defined margins, with 2 perpendicular diameters of at least 10 mm, visible on \\>= 2 axial slices\n* Patients must have received first-line treatment of temozolomide plus radiotherapy\n* Patients must not have received any prior therapy aside from resection or biopsy for their recurrent disease\n* Age \\>= 18 years. Because no dosing or adverse event data are currently available on the use of selinexor (KPT-330) in combination with temozolomide in patients \\\u003C 18 years of age, children are excluded from this study\n* Karnofsky performance status \\>= 60% (Eastern Cooperative Oncology Group \\[ECOG\\] =\\\u003C 2)\n* Absolute neutrophil count \\>= 1,500\u002FmcL\n* Platelets \\>= 100,000\u002FmcL\n* Hemoglobin \\>= 10 g\u002FdL\n* Total bilirubin =\\\u003C 2 x institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \\[SGOT\\])\u002Falanine transaminase (ALT) (serum glutamic-pyruvic transaminase \\[SGPT\\]) =\\\u003C 3 x institutional ULN\n* Glomerular filtration rate (GFR) \\>= 30 mL\u002Fmin\u002F1.73 m\\^2\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 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 2B or better\n* The effects of selinexor (KPT-330) and temozolomide on the developing human fetus are unknown. For this reason and because selective nuclear export inhibitors as well as deoxyribonucleic acid (DNA) alkylating agents 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 and for the duration of study participation, and for 180 days after the last dose of temozolomide. 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 90 days after completion of study treatment administration\n* Ability to understand and the willingness to sign a written informed consent document. Participants with impaired decision-making capacity who have a legally-authorized representative (LAR) and\u002For family member available will also be eligible\n\nExclusion Criteria:\n\n* Patients who have had chemotherapy must have full recovery of organ and marrow function following the nadir of the last chemotherapy cycle\n* Patients who have not recovered 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* Patients who have previously received bevacizumab\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to selinexor (KPT-330) or temozolomide\n* History of hypersensitivity to dacarbazine (DTIC), since both dacarbazine and temozolomide are metabolized to 5-(3-methyltriazen-1-yl)-imidazole-4-carboxamide (MTIC)\n* Patients with uncontrolled intercurrent illness\n* Pregnant women are excluded from this study because selinexor (KPT-330) is a selective inhibitor of nuclear export 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 selinexor (KPT-330), breastfeeding is not allowed for mothers during treatment with selinexor (KPT-330) and for 7 days after the last dose. These potential risks may also apply to other agents used in this study\n* Hospitalized patients with severe coronavirus disease of 2019 (COVID-19) who are \\>= 75 years old, or with a high-risk COVID-GRAM score, or with lactate dehydrogenase (LDH) \\> 370 (U\u002FL) AND D-Dimer \\> 600 mcg\u002FL FEU should not receive low-dose selinexor (KPT-330) pending additional results",{"count":156,"type":20},97,[23,158],"PHASE2","This phase I\u002FII trial tests the safety, side effects and best dose of selinexor given in combination with the usual chemotherapy (temozolomide) and compares the effect of this combination therapy versus the usual chemotherapy alone (temozolomide) in treating patients with glioblastoma that has come back (recurrent). Selinexor is in a class of medications called selective inhibitors of nuclear export (SINE). It works by blocking a protein called CRM1, which may keep cancer cells from growing and may kill them. Temozolomide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid and may kill tumor cells and slow down or stop tumor growth. Giving selinexor in combination with usual chemotherapy (temozolomide) may shrink or stabilize the tumor better than the usual chemotherapy with temozolomide alone in patients with recurrent glioblastoma.",[32,161],"Recurrent MGMT-Methylated Glioblastoma","2026-05-15",{"date":164,"type":37},"2026-05-18",{"date":166,"type":37},"2023-03-20",{"date":41,"type":20},{"name":43,"class":44},36,{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":4,"eligibilityCriteria":176,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":21,"phases":178,"briefSummary":179,"conditions":180,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":147},"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.",[32,181,182,118],"Recurrent WHO Grade 2 Glioma","Recurrent WHO Grade 3 Glioma","2026-04-29",{"date":185,"type":37},"2026-05-01",{"date":187,"type":37},"2024-07-23",{"date":189,"type":20},"2030-05-12",{"name":191,"class":80},"Northwestern University",{"id":193,"slug":194,"hasResults":11,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":4,"eligibilityCriteria":198,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":199,"targetDuration":4,"studyType":21,"phases":200,"briefSummary":201,"conditions":202,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":147},"100616104","phase-2-gi-102-alone-or-with-pembrolizumab-before-surgery-for-treatment-of-recurrent-or-progressive-idh-wildtype-glioblastoma-and-idh-mutated-grade-4-astrocytoma-100616104","NCT07301268","GI-102 Alone or With Pembrolizumab Before Surgery for Treatment of Recurrent or Progressive IDH Wildtype Glioblastoma and IDH Mutated Grade 4 Astrocytoma","MC230719 Window Of Opportunity Study Of GI-102 In Patients With Recurrent High-Grade Glioblastoma","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Disease characteristics\n\n  * Tissue-confirmed progressive or recurrent World Health Organization (WHO) grade IV IDH wildtype glioblastoma (including molecular glioblastoma and gliosarcoma); and IDH mutated WHO grade 4 astrocytoma\n  * Candidates for surgical resection\n* Measurable or non-measurable disease as defined by Response Assessment in Neuro-Oncology (RANO) 2.0\n* Willing to undergo clinically indicated biopsy followed by resection of high-grade glioma at Mayo Clinic in Rochester, Minnesota (MN)\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0,1, or 2 and Karnofsky performance status (KPS) ≥ 60\n\n  * NOTE: PS must be assessed (again) ≤ 7 days prior to first dose of study drug\n* Hemoglobin ≥ 9.0 g\u002FdL (obtained ≤ 15 days prior to registration)\n* Absolute neutrophil count (ANC) ≥ 1500\u002Fmm\\^3 (obtained ≤ 15 days prior to registration)\n* Platelet count ≥ 100,000\u002Fmm\\^3 (obtained ≤ 15 days prior to registration)\n* Creatinine ≤ 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance (per institutional standard) must be ≥ 45 ml\u002Fmin (obtained ≤ 15 days prior to registration)\n* Total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ ULN for patients with total bilirubin levels \\> 1.5 x ULN (obtained ≤ 15 days prior to registration)\n* Aspartate transaminase (AST) AND alanine transaminase (ALT) ≤ 2.5 x ULN (obtained ≤ 15 days prior to registration)\n* Amylase and lipase ≤ ULN (obtained ≤ 15 days prior to registration)\n* Left ventricular ejection fraction (LVEF) ≥ 50% (obtained ≤ 29 days prior to registration)\n* Negative pregnancy test done ≤ 8 days prior to registration, for persons of childbearing potential only\n* Persons of childbearing potential (POCBP) or able to father a child must be willing to use adequate contraception starting with first dose through 180 days after last dose\n* Provide written informed consent\n* Willingness to provide blood specimens for correlative research\n* Willingness to provide tissue specimens for correlative research\n* Willingness to provide written informed consent for the neuro-oncology biorepository (IRB 12-003458) for archiving of tissue, cerebrospinal fluid (CSF), and\u002For blood samples collected on this protocol\n* Willingness to return to enrolling institution for follow-up (during the active monitoring phase of the study)\n\nExclusion Criteria:\n\n* Any of the following because this study involves an investigational agent, the genotoxic, mutagenic, and teratogenic effects of which on the developing fetus and newborn are unknown:\n\n  * Pregnant persons\n  * Nursing persons\n  * Persons of childbearing potential or able to father a child who are unwilling to employ adequate contraception\n* Signs or symptoms of life-threatening raised intracranial pressure: as determined by the treating neurosurgeon, including severe headache, nausea, decreasing level of consciousness, precluding 4-7-day delay in scheduling neurosurgery (i.e., immediate surgery is indicated, and patient cannot wait)\n* Prior treatment\n\n  * Received bevacizumab (AVASTIN) \\\u003C 30 days prior to registration\n\n    * NOTE: Bevacizumab is allowed for symptom control during the adjuvant phase of the study\n  * Increasing dexamethasone dose prior to registration\n\n    * NOTE: Patients currently on dexamethasone must be on dose ≤ 4 mg\u002Fday at time of registration\n  * Received chemotherapy \\\u003C 30 days prior to registration\n  * Received a live vaccine \\\u003C 30 days prior to registration\n* Failure to recover from any adverse events related to any of the following therapies received prior to registration:\n\n  * Major surgery \\\u003C 28 days prior to registration\n  * Radiation therapy \\\u003C 14 days prior to registration\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Uncontrolled intercurrent illness including, but not limited to:\n\n  * Ongoing or active infection requiring IV antibiotics\n  * Symptomatic congestive heart failure\n  * Unstable angina pectoris\n  * Cardiac arrhythmia\n  * Or psychiatric illness\u002Fsocial situations (e.g., drug addiction) that would limit compliance with study requirements\n* Receiving any other investigational agent at the time of registration\n* History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias\n* Active autoimmune disease that has required systemic treatment (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) ≤ 2 years prior to registration\n\n  * NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment\n* Concurrent known active hepatitis B (i.e., known positive hepatitis B virus \\[HBV\\] surface antigen \\[HBsAg\\] reactive) AND known active hepatitis C (i.e., hepatitis C virus \\[HCV\\] ribonucleic acid \\[RNA\\] \\[qualitative\\] detected by polymerase chain reaction \\[PCR\\]). Note: No testing for hepatitis B and hepatitis C is required unless mandated by local health authority\n\n  * NOTE: Patients with known hepatitis B OR hepatitis C may be enrolled if they meet the following criteria:\n\n    * Hepatitis B: Patients who are HBsAG positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization. Patients should remain on anti-viral therapy throughout the treatment phase of the trial and should follow local guidelines for HBV anti-viral therapy after completing study treatment\n    * Hepatitis C: Patients with history of hepatitis C infection are eligible if HCV viral load is undetectable at screening. Patients must have completed curative anti-viral therapy at least 4 weeks prior to registration\n* Known history of active TB (Bacillus tuberculosis)\n* History of (non-infectious) pneumonitis or interstitial lung disease that required steroids, or current pneumonitis or interstitial lung disease\n* Hypersensitivity to pembrolizumab, IL-2, GI-102 or any of its excipients\n* History of allogeneic tissue\u002Fsolid organ transplant",{"count":169,"type":20},[158],"This phase II trial compares the effect of GI-102 alone and in combination with pembrolizumab given before surgery in treating patients with IDH wildtype glioblastoma and IDH mutated grade 4 astrocytoma that has come back after a period of improvement (recurrent) or that is growing, spreading, or getting worse (progressive). Glioblastoma is the most common and the most aggressive primary brain tumor in adults. Current standard of care includes surgical resection, radiation and chemotherapy. Treatment is often given before surgery (neoadjuvant therapy) to shrink the tumor and make it easier to remove. Treatment with GI-102, a bispecific fusion protein, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Giving GI-102 alone and in combination with pembrolizumab between neoadjuvant therapy and surgery may be safe, tolerable, and effective in treating patients with recurrent or progressive IDH wildtype glioblastoma and IDH mutated grade 4 astrocytoma.",[203,204,205,206,31,32,117,207,208],"Glioblastoma, IDH-Wildtype","Progressive Astrocytoma, IDH-Mutant, Grade 4","Progressive Glioblastoma","Progressive Gliosarcoma","Resectable Astrocytoma","Resectable Glioblastoma","2026-04-02",{"date":211,"type":37},"2026-04-08",{"date":213,"type":37},"2026-04-01",{"date":215,"type":20},"2034-04-30",{"name":217,"class":80},"Mayo Clinic",{"id":219,"slug":220,"hasResults":11,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":4,"eligibilityCriteria":224,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":225,"targetDuration":4,"studyType":21,"phases":227,"briefSummary":228,"conditions":229,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":147},"100499910","phase-1-allogenic-adipose-derived-mesenchymal-stem-cells-for-the-treatment-of-recurrent-glioblastoma-or-recurrent-astrocytoma-in-patients-undergoing-craniotomy-100499910","NCT05789394","Allogenic Adipose-Derived Mesenchymal Stem Cells for the Treatment of Recurrent Glioblastoma or Recurrent Astrocytoma in Patients Undergoing Craniotomy","Phase 1, Dose Escalation, Non-Randomized, Open Label, Clinical Trial Evaluating the Safety and Preliminary Efficacy of Allogenic Adipose-Derived Mesenchymal Stem Cells (AMSCs) for Recurrent Glioblastoma","Inclusion Criteria:\n\n* Participants \\>= 18 years\n* Karnofsky Performance Scale (KPS) \\>= 60\n* Negative pregnancy test done =\\\u003C 7 days prior to registration, for persons of childbearing potential only\n* Patients with a previous histological diagnosis of glioblastoma multiforme, isocitrate dehydrogenase (IDH) wildtype (WT) or astrocytoma, IDH-mutant World Health Organization (WHO) grade IV according to the 2021 WHO classification of tumors of the central nervous system , who are candidates to- and will undergo a redo craniotomy for excision of recurrent tumor\n* There is measurable disease according to the immunotherapy response assessment in neuro-oncology (iRANO) criteria\n* Serum creatinine and urea \\\u003C= 2 times the upper limit of normal (=\\\u003C 3 weeks prior to registration)\n* Alanine transaminase (ALT), aspartate transferase (AST) and alkaline phosphatase =\\\u003C 3 times the upper limit of normal, and bilirubin =\\\u003C 2.5 mg\u002FdL (=\\\u003C 3 weeks prior to registration)\n* Prothrombin time =\\\u003C 1.5 times upper limit of normal (=\\\u003C 3 weeks prior to registration)\n* International normalized ratio (INR) and partial thromboplastin time (PTT) =\\\u003C 1.5 times the upper limit of normal (=\\\u003C 3 weeks prior to registration)\n* Hemoglobin \\>= 9 g\u002FdL (=\\\u003C 3 weeks prior to registration)\n* Platelets \\>= 100 x 10\\^9\u002FL (=\\\u003C 3 weeks prior to registration)\n* Absolute neutrophil count (ANC) \\>= 1.5 x 10\\^9\u002FL (=\\\u003C 3 weeks prior to registration)\n* Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)\n* Patient or legally authorized representative (LAR) is able to fully understand and provide written and verbal consent for the protocol\n* Willingness to provide mandatory blood specimens for correlative research\n* Willingness to provide mandatory tissue specimens for correlative research\n* Willingness to undergo Ommaya reservoir placement and provide cerebrospinal fluid (CSF) samples for correlative research\n\nExclusion Criteria:\n\n* Patients who are undergoing needle biopsy only or non-eligible for a surgical intervention\n* Tumors located solely in the brain stem, midbrain, or thalamus without inclusion\u002Finvolvement of surrounding brain matter\n* Previous treatment with bevacizumab\n* Radiographic evidence of leptomeningeal disease",{"count":226,"type":20},20,[23],"This phase I trial tests the safety, side effects, and best dose of allogenic adipose-derived mesenchymal stem cells (AMSCs) in treating patients with glioblastoma or astrocytoma that has come back (recurrent) who are undergoing brain surgery (craniotomy). Glioblastoma is the most common and most aggressive form of primary and malignant tumor of the brain. Currently, the standard of care for this disease includes surgical resection, followed by radiation with chemotherapy and tumor treating fields. Despite this aggressive therapy, the survival after finishing treatment remains low and the disease often reoccurs. Unfortunately, the available therapy options for recurrent glioblastoma are minimal and do not have a great effect on survival. AMSCs are found in body fat and when separated from the fat, are delivered into the surgical cavity at the time of surgery. When in direct contact with tumor cells, AMSCs affect tumor growth, residual tumor cell death, and chemotherapy resistance. The use of AMSCs delivered locally into the surgical cavity of recurrent glioblastoma during a craniotomy could improve the long-term outcomes of these patients by decreasing the progression rate and invasiveness of malignant cells.",[32,31,230],"Astrocytoma, Grade IV","2026-03-31",{"date":209,"type":37},{"date":234,"type":37},"2023-06-16",{"date":236,"type":20},"2027-07-24",{"name":217,"class":80},{"id":239,"slug":240,"hasResults":11,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":4,"eligibilityCriteria":244,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":245,"enrollmentInfo":246,"targetDuration":4,"studyType":21,"phases":248,"briefSummary":249,"conditions":250,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":147},"100617453","phase-1-a-clinical-trial-of-p134-cells-in-recurrent-glioblastoma-100617453","NCT07318818","A Clinical Trial of P134 Cells in Recurrent Glioblastoma","A Phase I\u002FII Clinical Study to Evaluate the Safety and Efficacy of P134 Cells in the Treatment of Recurrent Glioblastoma","Inclusion Criteria:\n\n1. Voluntary written informed consent.\n2. 18-70 years of age (inclusive), male or female.\n3. Recurrent or progressive glioblastoma, histopathologically or molecularly diagnosed consistent with grade 4 glioblastoma (IDH wild-type) (refer to WHO Classification of Central Nervous System Tumors, 5th Edition, 2021).\n4. Positive CD44 or CD133 antigen expression in tumor tissue confirmed by IHC, defined as ≥1% of tumor cells showing positive CD44 or CD133 IHC staining, regardless of intensity (applicable only in Phase II dose expansion study).\n5. At least one measurable lesion meeting RANO 2.0 criteria and having a radiographically assessed measurable lesion ≤ 3 cm in longest diameter\n6. Patient has received prior radiation therapy and\u002For temozolomide\u002Fbevacizumab.\n7. The investigator confirmed that the patient was suitable for craniotomy cerebrospinal fluid shunt and accessory (Ommaya reservoir) implantation.\n\nExclusion Criteria:\n\n1. Highly allergic constitution or history of severe allergy, or allergy to related cell products\n2. Receipt of biologic anti-tumor therapy (including monoclonal or bispecific antibody-targeted therapy, immune checkpoint inhibitor therapy, etc.) within 6 weeks prior to PBMC collection; receipt of radiotherapy or surgery within 4 weeks prior to PBMC collection (excluding placement of vascular access devices; a 1-week washout period is acceptable for diagnostic biopsy surgeries); receipt of chemotherapy, hormone therapy (excluding hormone replacement therapy), or non-specific immunomodulatory therapy (such as interleukins, interferons, thymosin, cyclophosphamide, methotrexate, tumor necrosis factor, etc.) within 2 weeks prior to PBMC collection; receipt of traditional Chinese medicine therapy with a clear anticancer indication within 1 week prior to PBMC collection.\n3. The adverse reactions caused by previous anti-tumor treatment have not recovered to ≤ Grade 1 as evaluated by NCI CTCAE v6.0 (except alopecia, skin pigmentation, leukoplakia, etc. which are assessed as having no safety risk).\n4. Tumor metastasis to the brainstem or spinal cord.\n5. Suffering from other serious neurological diseases other than brain tumors, such as meningitis, encephalitis, myelitis and demyelination, myasthenic syndrome\u002Fmyasthenia gravis, amyotrophic lateral sclerosis, spinal muscular atrophy, nerve paralysis, uncontrolled epilepsy, etc.\n6. Patients with primary immunodeficiency disease, autoimmune diseases requiring medication (such as Crohn 's disease, ulcerative colitis, rheumatoid arthritis, systemic lupus), or previous history of autoimmune diseases of the nervous system (such as multiple sclerosis, Parkinson' s disease).\n7. Receiving or requiring long-term use of immunosuppressive agents (except for physiological doses of systemic corticosteroids ≤ 10 mg\u002Fday prednisone equivalent, short-term ≤ 7 days corticosteroids for allergies, or topical glucocorticoids).\n8. Trial participants who have a previous history of allogeneic bone marrow transplantation or organ transplantation, or are awaiting organ transplantation.\n9. HBsAg positive and HBV DNA positive, HCV Ab positive and HCV RNA positive; Treponema pallidum antibody positive; human immunodeficiency virus (HIV) antibody positive.\n10. Prior receipt of any gene therapy or cell therapy trial participant.\n11. Pregnant or lactating women.\n12. History of malignancy other than glioma within 5 years (except for adequately treated carcinoma in situ, basal cell carcinoma of the skin, squamous cell carcinoma of the skin, localized prostate cancer, or stage I cervical cancer, which in the opinion of the investigator carries a minimal risk of recurrence).","70 Years",{"count":247,"type":20},26,[23,158],"This is an open-label, single-arm, dose-escalation and expansion Phase 1\u002F2 clinical trial designed to evaluate the safety, tolerability and efficacy of P134 cells in patients with recurrent glioblastoma, to explore the maximum tolerated dose (MTD)and recommended Phase 2 dose (RP2D), and to characterize the cytokinetic profile of CAR-T cells in the cerebrospinal fluid of patients. Eligible participants are adults diagnosed with recurrent or progressive glioblastoma who are confirmed as grade 4 glioblastoma (IDH wild-type) by histopathology or molecular pathology.\n\nP134 cells are CD44\u002FCD133 dual-targeting CAR-T cells developed by the research team led by Academician Jiang Tao and Professor Zhang Wei from the Beijing Neurosurgical Institute and the Department of Neurosurgery, Beijing Tiantan Hospital. This study is spearheaded by Professor Zhang Wei of the Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University, China, with scientific oversight and guidance provided by Academician Jiang Tao of the Chinese Academy of Engineering.",[63],"2026-02-13",{"date":253,"type":37},"2026-02-18",{"date":255,"type":37},"2026-01-05",{"date":257,"type":20},"2028-08-31",{"name":259,"class":260},"Tasly Pharmaceutical Group Co., Ltd","INDUSTRY",{"id":262,"slug":263,"hasResults":11,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":267,"eligibilityCriteria":268,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":269,"targetDuration":4,"studyType":21,"phases":271,"briefSummary":273,"conditions":274,"keywords":4,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":147},"100619828","phase-2-comparison-of-cerebraca-wafer-plus-temozolomide-versus-temozolomide-alone-in-recurrent-glioblastoma-100619828","NCT07349693","Comparison of Cerebraca Wafer Plus Temozolomide Versus Temozolomide Alone in Recurrent Glioblastoma","A Randomized Trial to Assess the Efficacy and Safety of Cerebraca Wafer Plus Temozolomide Versus Temozolomide Alone in Recurrent Glioblastoma","Cerebraca-02\u002F3","Inclusion Criteria, subjects must meet all following criteria for study enrollment:\n\n1. Subject must be aged ≥ 18, regardless of gender\n2. Subject must have histologically confirmed glioblastoma with:\n\n   1. Completed first-line therapy including surgery plus temozolomide and radiation (concurrent temozolomide\u002Fradiation)\n   2. Current presentation being first or second recurrence only\n3. Subject must have measurable disease preoperatively with at least one contrast-enhancing MRI-identified lesion measuring ≥ 1 cm in two perpendicular dimensions per RANO 2.0 criteria\n4. Subject must be deemed eligible for gross total resection of contrast-enhancing MRI-identified lesion by neurosurgeon's pre-operative assessment, according to RANO II\n5. Subject must have Karnofsky Performance Status (KPS) ≥ 70\n6. Subject must have recovered from prior therapy toxicities with adequate organ function:\n\n   1. Hemoglobin ≥ 8 g\u002FdL\n   2. Platelets ≥ 100,000\u002Fmm3\n   3. White blood cell count (WBC) ≥ 3,000 cells\u002Fmm3\n   4. Absolute neutrophil count (ANC) ≥ 1,500 cells\u002Fmm3\n   5. Absolute lymphocyte count (ALC) ≥ 1,000 cells\u002Fmm3\n   6. Coagulation tests (prothrombin time \\[PT\\], activated partial thromboplastin time \\[APTT\\], International Normalized Ratio \\[INR\\]) ≤ 1.5 × ULN\n   7. Total bilirubin (TBIL) \\\u003C 3 × ULN\n   8. Alkaline phosphatase (ALP) ≤ 3 × ULN and\u002For Gamma glutamyltransferase (GGT) ≤ 1.5 × ULN\n   9. Aspartate aminotransferase (AST)\u002Fserum glutamic oxaloacetic transaminase (SGOT) and\u002For Alanine aminotransferase (ALT)\u002Fserum glutamic pyruvic transaminase (SGPT) ≤ 3 x ULN\n   10. eGFR ≥ 30 mL\u002Fmin (MDRD formula)\n   11. QTc interval: msec ≤ 450 (males) or 470 (females) (Fridericia's formula: QTc=QT\u002FRR(1\u002F3); RR=RR interval)\n\nExclusion Criteria, subjects with any of the following will be excluded:\n\n1. Histological confirmation of oligodendroglioma or mixed glioma\n2. Presence of IDH or H3K27M mutation, or 1p19q co-deletion\n3. MRI-identified lesion meeting any criteria:\n\n   1. Multi-focal (defined as 2 non-contiguous contrast enhancement areas \\> 1 cm in 2 planes on fluid-attenuated inversion recovery, FLAIR or T2-weighted sequences)\n   2. Presence of diffuse subependymal or leptomeningeal dissemination\n   3. Contrast-enhancing lesion \\> 6 cm in any dimension\n4. Tumor location unsuitable for surgical resection and Cerebraca Wafer implantation in the brain areas where surgical intervention would cause significant neurological deficits\n5. Prior bevacizumab treatment with uncontrollable tumor progression\n6. History of other malignancy within past 5 years\n7. Immunocompromised status or autoimmune conditions requiring systemic immunosuppressive therapy, with the following exceptions:\n\n   1. Patients with autoimmune conditions may be eligible after individual assessment of the condition, its severity, and potential interaction with the Cerebraca Wafer.\n   2. Patients with HIV infection are eligible if they:\n\n   i. Have CD4+ T-cell counts ≥350 cells\u002FμL ii. Are on stable anti-retroviral therapy iii. Have HIV viral load below the limit of quantification c. Patients with HBV infection are eligible if they: i. Are on appropriate suppressive anti-viral therapy prior to study enrollment ii. Have no evidence of hepatic decompensation d. Patients with history of HCV infection are eligible if they: i. Have completed curative anti-viral treatment with HCV viral load below the limit of quantification\n8. Active, uncontrolled infection or medical condition that could compromise safety and efficacy assessment",{"count":270,"type":20},175,[158,272],"PHASE3","This study is designed as a multi-center, randomized, open-label trial to evaluate the efficacy of Cerebraca Wafer in patients with recurrent glioblastoma. Cerebraca Wafer is intended for use in recurrent glioblastoma as an adjunct to surgery (followed by standard-of-care temozolomide), demonstrating potential to improve outcomes in this serious and life-threatening condition",[32],"2026-01-15",{"date":277,"type":37},"2026-01-20",{"date":279,"type":20},"2026-11-01",{"date":281,"type":20},"2030-12-01",{"name":283,"class":260},"Everfront Biotech Co., Ltd.",{"id":285,"slug":286,"hasResults":11,"nctId":287,"briefTitle":288,"officialTitle":289,"acronym":4,"eligibilityCriteria":290,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":291,"targetDuration":4,"studyType":21,"phases":293,"briefSummary":294,"conditions":295,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":147},"100475057","phase-2-efineptakin-alfa-and-pembrolizumab-for-the-treatment-of-recurrent-glioblastoma-100475057","NCT05465954","Efineptakin Alfa and Pembrolizumab for the Treatment of Recurrent Glioblastoma","Efficacy and Safety Study of Neoadjuvant Efineptakin Alfa (NT-I7) and Pembrolizumab in Recurrent Glioblastoma","Inclusion Criteria:\n\n* Age \\>= 18 years\n* Disease characteristics:\n\n  * Tissue-confirmed progressive or recurrent World Health Organization (WHO) Grade IV IDH wildtype glioblastoma (including molecular glioblastoma and gliosarcoma)\n  * Previously treated with maximum feasible resection or biopsy, radiation, and temozolomide\n* Have an enhancing mass on magnetic resonance imaging (MRI) amenable to resection or biopsy of the tumor (as determined by the neurosurgeon pre-operatively) and histological diagnosis of glioblastoma from a prior biopsy or surgery\n* Willing to undergo clinically indicated biopsy and\u002For resection of their glioblastoma at Mayo Clinic in Rochester, Minnesota (MN).\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1 and Karnofsky Performance Scale (KPS) \\>= 70 NOTE: PS must be assessed (again) within 7 days prior to first dose of study drug\n* Hemoglobin \\>= 9.0 g\u002FdL (obtained =\\\u003C 15 days prior to registration) (without transfusion or erythropoietin \\[EPO\\] dependency =\\\u003C 7 days prior to assessment)\n* Absolute neutrophil count (ANC) \\>= 1500\u002Fmm\\^3 (obtained =\\\u003C 15 days prior to registration)\n* Platelet count \\>= 100,000\u002Fmm\\^3 (obtained =\\\u003C 15 days prior to registration)\n* Creatinine =\\\u003C 1.5 x upper limits of normal (ULN) OR measured or calculated creatinine clearance (per institutional standard) must be \\>= 45 ml\u002Fmin (obtained =\\\u003C 15 days prior to registration)\n* Total bilirubin =\\\u003C1.5 x ULN OR direct bilirubin =\\\u003C ULN for patients with total bilirubin levels \\>1.5 x ULN (obtained =\\\u003C 15 days prior to registration)\n* Aspartate transaminase (AST) AND alanine transaminase (ALT) =\\\u003C 2.5 x ULN (obtained =\\\u003C 15 days prior to registration)\n* Prothrombin time (PT)\u002Finternational normalized ratio (INR)\u002Factivated partial thromboplastin time (aPTT) =\\\u003C 1.5 x ULN OR if patient is receiving anticoagulant therapy then INR or aPTT is within target range of therapy (obtained =\\\u003C 15 days prior to registration)\n* Negative pregnancy test done =\\\u003C 7 days prior to registration, for persons of childbearing potential only (POCBP) Note: If testing done for eligibility is \\> 72 hours prior to first dose, then pregnancy testing must be repeated, and result must be negative for patient to receive treatment.\n* POCBP or able to father a child must be willing to use adequate contraception starting with first dose through 180 days after last dose\n* Provide written informed consent\n* Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study).\n* Willing to provide tissue and blood samples for correlative research purposes\n\nExclusion Criteria:\n\n* Any of the following because this study involves an investigational agent for which 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 or able to father a child who are unwilling to employ adequate contraception\n* Signs or symptoms of life-threatening raised intracranial pressure: as determined by the treating neurosurgeon, including severe headache, nausea, decreasing level of consciousness, precluding 4-7-day delay in scheduling neurosurgery (i.e., immediate surgery is indicated, and patient cannot wait).\n* Prior treatment\n\n  * Received bevacizumab (AVASTIN) =\\\u003C 4 months prior to registration\n\n    * Note: Bevacizumab is allowed for symptom control during the adjuvant phase of the study\n  * Received a live vaccine =\\\u003C 30 days prior to registration.\n  * Requirement for dexamethasone dose of \\> 2mg\u002Fday =\\\u003C 2 days prior to registration\n* Failure to recover from any adverse events related to any of the following therapies received prior to registration:\n\n  * Major surgery =\\\u003C 28 days prior to registration\n  * Radiation therapy =\\\u003C 14 days prior to registration\n* Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens\n* Known history of human immunodeficiency virus (HIV) infection\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations (e.g., drug addiction) that would limit compliance with study requirements\n* Receiving any other investigational agent\n* Other active malignancy requiring systemic treatment =\\\u003C 1 year prior to registration\n* History of myocardial infarction =\\\u003C 6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias\n* Active autoimmune disease that has required systemic treatment (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs) =\\\u003C 2 years prior to registration NOTE: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment\n* Concurrent known active Hepatitis B (i.e., known positive hepatitis B virus \\[HBV\\] surface antigen \\[HBsAg\\] reactive) AND known active Hepatitis C (i.e., hepatitis C virus \\[HCV\\] ribonucleic acid \\[RNA\\] \\[qualitative\\] detected by polymerase chain reaction \\[PCR\\])\n\n  * Note: No testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority\n  * NOTE: Patients with known Hepatitis B OR Hepatitis C may be enrolled if they meet the following criteria:\n\n    * Hepatitis B: Patients who are HBsAG positive are eligible if they have received HBV antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization. Patients should remain on anti-viral therapy throughout the treatment phase of the trial and should follow local guidelines for HBV anti-viral therapy after completing study treatment\n    * Hepatitis C: Patients with history of Hepatitis C infection are eligible if HCV viral load is undetectable at screening. Patients must have completed curative anti-viral therapy at least 4 weeks prior to registration\n* Known history of active TB (Bacillus Tuberculosis)\n* History of (non-infectious) pneumonitis or interstitial lung disease that required steroids, or current pneumonitis or interstitial lung disease\n* Hypersensitivity to pembrolizumab or any of its excipients\n* Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent within \\\u003C 12 months prior to registration\n\n  * NOTE: If such therapy was given ≥ 12 months prior to registration, patient is eligible\n* History of allogenic tissue\u002Fsolid organ transplant",{"count":292,"type":20},54,[158],"This phase II trial tests the safety and side effects of efineptakin alfa and pembrolizumab in treating patients with glioblastoma that has come back (recurrent). Efineptakin alfa is an immunotherapy drug that works by helping the immune system fight tumor cells. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving efineptakin alfa and pembrolizumab may kill more tumor cells in patients with recurrent glioblastoma.",[296,32,117],"High Grade Astrocytic Tumor","2026-01-09",{"date":299,"type":37},"2026-01-12",{"date":301,"type":37},"2023-01-24",{"date":303,"type":20},"2028-10-15",{"name":217,"class":80},{"id":306,"slug":307,"hasResults":11,"nctId":308,"briefTitle":309,"officialTitle":310,"acronym":4,"eligibilityCriteria":311,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":312,"targetDuration":4,"studyType":21,"phases":314,"briefSummary":315,"conditions":316,"keywords":317,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":328,"startDateStruct":330,"completionDateStruct":332,"leadSponsor":334,"locationsCount":147},"100551093","phase-1-d2c7-it--2141-v11-combination-post-resection-in-rgbm-100551093","NCT06455605","D2C7-IT + 2141-V11 Combination Post-resection in rGBM","Clinical Trial of D2C7-IT + 2141-V11 Combination Immunotherapy Administered Via Convection Enhanced Delivery in Non-enhancing Tumor Post-resection of Recurrent Glioblastoma, Followed by Cervical Perilymphatic Subcutaneous Injections of 2141-V11","Inclusion Criteria:\n\n1. Age ≥ 18 years old at the time of entry into the study\n2. Histopathologically confirmed WHO grade 4 IDHwt GBM (high grade glioma with molecular features of glioblastoma will be eligible)\n3. Karnofsky Performance Score (KPS) ≥ 70%\n4. Hemoglobin ≥ 9 g\u002Fdl prior to biopsy\n5. Platelet count ≥ 100,000\u002Fµl unsupported is necessary for eligibility on the study; however, because of risks of intracranial hemorrhage with catheter placement, platelet count ≥ 125,000\u002Fµl is required for the patient to undergo biopsy and catheter insertion, which can be attained with the help of platelet transfusion.\n6. Neutrophil count ≥ 1000 prior to biopsy\n7. Creatinine ≤ 1.5 x normal range prior to biopsy\n8. Total bilirubin ≤ 1.5 x ULN prior to biopsy (Exception: Participant has known or suspected Gilbert's Syndrome for which additional lab testing of direct and\u002For indirect bilirubin supports this diagnosis. In these instances, a total bilirubin of ≤ 3.0 x ULN is acceptable.)\n9. AST\u002FALT ≤ 2.5 x ULN\n10. Prothrombin and Partial Thromboplastin Times ≤ 1.2 x normal prior to biopsy. Patients with prior history of thrombosis\u002Fembolism are allowed to be on anticoagulation, understanding that anticoagulation will be held in the perioperative period per the neurosurgical team's recommendations. Low molecular weight heparin (LMWH) is preferred. If a patient is on warfarin, the international normalized ratio (INR) is to be obtained and value should be below 2.0 prior to surgical resection and biopsy.\n11. Patient must have undergone resection per the recommendation of their treating physician 3-5 weeks prior to administration of D2C7-IT, and the presence of recurrent tumor must have been confirmed by histopathological analysis.\n12. Able to undergo brain MRI with and without contrast\n\n    a. Post-surgery MRI must demonstrate a residual area of non-enhancing disease that is amenable to CED infusion (no larger than 3 x 3 cm of residual enhancing disease per screening MRI)\n13. Patient or partner(s) meets one of the following criteria:\n\n    1. Non-childbearing potential (i.e. not sexually active, physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile, or any male who has had a vasectomy). Surgically sterile females are defined as those with a documented hysterectomy and\u002For bilateral oophorectomy or tubal ligation. Postmenopausal for purposes of this study is defined as 1 year without menses.; or\n    2. Childbearing potential and agrees to use one of the following methods of birth control: approved hormonal contraceptives (e.g. birth control pills, patches, implants, or infusions), an intrauterine device, or a barrier method of contraception (e.g. a condom or diaphragm) used with spermicide.\n14. A signed ICF approved by the IRB will be required for patient enrollment into the study. Patients must be able to read and understand the ICF and must sign the ICF indicating that they are aware of the investigational nature of this study\n\nExclusion Criteria:\n\n1. Females who are pregnant (negative pregnancy test at screening visit) or breast- feeding\n2. Patients with an impending, life-threatening cerebral herniation syndrome, based on the assessment of the study neurosurgeons or their designate\n3. Patients with severe, active co-morbidity, defined as follow:\n\n   1. Patients with an active infection requiring intravenous treatment or having an unexplained febrile illness (Tmax \\> 99.5°F\u002F37.5°C)\n   2. Patients with known immunosuppressive disease or known human immunodeficiency virus infection\n   3. Patients with unstable or severe intercurrent medical conditions such as severe heart disease (New York Heart Association Class 3 or 4)\n   4. Patients with known lung (forced expiratory volume in the first second of expiration (FEV1) \\\u003C 50%) disease or uncontrolled diabetes mellitus\n   5. Patients with albumin allergy\n4. Patients may not have received chemotherapy or bevacizumab ≤ 4 weeks \\[except for nitrosourea (6 weeks), or metronomic dosed chemotherapy such as daily etoposide or cyclophosphamide (1 week)\\] prior to starting the study drug unless patients have recovered from side effects of such therapy\n5. Patients may not have received immunotherapy ≤ 4 weeks prior to starting the study drug unless patients have recovered from side effects of such therapy\n6. Patients may not have received treatment with tumor treating fields (e.g., Optune®)\n\n   * 1 week prior to starting the study drug\n7. Patients may not be less than 12 weeks from radiation therapy, unless progressive disease outside of the radiation field or 2 progressive scans at least 4 weeks apart or histopathologic confirmation\n8. Patients who have not completed all standard of care treatments, including surgical procedure and radiation therapy (Please note: For patients under 65 years old, standard radiation therapy is typically at least 59 Gy in 30 fractions over 6 weeks. For patients 65 years or older, standard RT is often reduced to a minimum 40 Gy in 15 fractions over 3 weeks.)\n\n   1. If the MGMT promoter in their tumor is known to be unmethylated, patients are not mandated to have received chemotherapy prior to participating in this trial\n   2. If the MGMT promoter in their tumor is known to be methylated or the MGMT promoter methylation status is unknown at time of screening, patients must have received at least one chemotherapy regimen prior to participating in this trial\n9. Patients with neoplastic lesions in the brainstem, cerebellum, or spinal cord; radiological evidence of active (growing) disease (active multifocal disease); extensive subependymal disease (tumor touching subependymal space is allowed); tumor crossing the midline or leptomeningeal disease\n10. Patients on greater than 4 mg per day of dexamethasone within the 2 weeks prior to the D2C7-IT infusion\n11. Patients with worsening steroid myopathy (history of gradual progression of bilateral proximal muscle weakness, and atrophy of proximal muscle groups)\n12. Patients with prior, unrelated malignancy requiring current active treatment with the exception of cervical carcinoma in situ and adequately treated basal cell or squamous cell carcinoma of the skin\n13. Patients with active autoimmune disease requiring systemic immunomodulatory treatment within the past 3 months\n14. Patients who cannot undergo MRI due to obesity or to having certain metal in their bodies (i.e. pacemakers, infusion pumps, metal aneurysm clips, metal prostheses, joints, rods, or plates)",{"count":313,"type":20},46,[23],"The purpose of this study is to assess the safety and efficacy of the combination of D2C7-IT+2141-V11 administered in the non-enhancing tumor of patients with resected recurrent glioblastoma (rGBM) via convection enhanced delivery (CED), followed by subcutaneous cervical perilymphatic injections (CPLIs) of 2141-V11 2 and 4 weeks post infusion, then every 3 weeks for a year, and every 4-6 weeks thereafter if patients benefit from therapy.",[63],[318,319,320,321,322,323,324,325,326],"D2C7","D2C7-IT","2141-V11","Pro00115800","GBM","Glioblastoma","convection-enhanced delivery","CED","IDHwt","2025-10-21",{"date":329,"type":37},"2025-10-23",{"date":331,"type":37},"2025-03-17",{"date":333,"type":20},"2030-01-31",{"name":335,"class":80},"Darell Bigner"]