[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-malignant-glioma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-malignant-glioma":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,45,85,113],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100590232","phase-1-anti-garp-chimeric-antigen-receptor-t-cell-therapy-for-the-treatment-of-recurrent-grade-iii-or-iv-gliomas-100590232",false,"NCT06964737","Anti-GARP Chimeric Antigen Receptor T Cell Therapy for the Treatment of Recurrent Grade III or IV Gliomas","A Phase I, Dose-Escalation Trial of Anti-GARP Chimeric Antigen Receptor-T Cell Therapy in Patients With Recurrent High-Grade Glioma Treated at a Single Medical Center","Inclusion Criteria:\n\n* Patients are ≥ 18 years old\n* Capacity to understand and willingness to provide written informed consent\n* Diagnosis or clinical suspicion of recurrent malignant glioma, including:\n\n  * History of high-grade glioma (World Health Organization \\[WHO\\] grade III or IV), or\n  * Prior, histologically-confirmed diagnosis of grade II glioma with new radiographic findings consistent with a high-grade glioma\n* Imaging and\u002For histopathological confirmation of recurrent disease, or verification of \"high risk\" histology confirmed by a biopsy with measurable disease by the Radiologic Assessment in Neuro-Oncology (RANO) criteria\n* Patient has unifocal disease in one hemisphere and is supratentorial. Lesion and edema can not be located in eloquent locations (e.g., brainstem, pre-\u002Fpost-central gyrus, visual cortex) or within 2 gyri of motor strip.\n* If on steroids such as dexamethasone, must be on a low dose (≤ 4mg per day) at the time of treatment, and not at an ascending dosage schedule at time of enrollment\u002Fleukapheresis\n\n  * Prior to apheresis and treatment 1 a 2- week washout should be observed\n* Subjects must not have received bevacizumab therapy and are not planned to start such therapy\n* Karnofsky performance score (KPS) ≥ 60\n* Subject is a surgical candidate for surgery for malignant glioma with the intent of resecting \\>80-90% of the tumor as the ideal treatment option\n* White blood cells (WBC) \\> 4,000 cells\u002FuL\n* Hemoglobin (Hgb) \\> 7 gm\u002FdL\n* Platelets (Plt) \\> 100\u002FdL\n* Serum creatinine ≤ 1.5 x institutional upper limit of normal\n* Liver function tests within 1.5 x institutional upper limit of normal\n* Women of reproductive potential must have a negative pregnancy test within 7 days of study start. All patients of reproductive potential must use a physician-approved contraceptive and refrain from sperm donation for at least two weeks prior, during, and six months after final T cell infusion. Women must refrain from breastfeeding for six months after final T cell infusion\n* Sufficient venous access, to be confirmed prior to apheresis\n* Life expectancy of greater than 12 weeks\n* PI clinical judgement of patients who will likely complete the trial and are able to maintain stable neurologic symptoms during intervention period\n\nExclusion Criteria:\n\n* Patients who have a history of malignancy other than the glioma under investigation in this study, except patients with the following malignancies\u002Ftreatment characteristics, who are eligible at the investigator's discretion:\n\n  * Patients with a history of malignancy that has been treated with curative intent at least 2 years prior to screening and with no evidence of relapse, if no concurrent anti-cancer therapy (except hormonal therapy) is being given\n  * Patients with a history of malignancy with a negligible risk of metastasis or death (e.g., 5-year OS rate \\> 90%) such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or stage I uterine cancer\n  * Patients who have prostate cancer with no evidence of metastatic disease and are not on active therapy, except anti-androgen therapy\n* History of autoimmune disease, or other diseases require long-term administration of high-dose steroids \\[\\> 10 mgs\u002Fday\\] or immunosuppressive therapies\n\n  * Research participants who received steroids must have either received their last dose of steroids 7 days or more prior to apheresis or have dosage tapered to \\\u003C 2mg\u002Fkg\u002Fday\n* Patients being treated concurrently (within 14 days prior to study enrollment) with any other investigational agent\n\n  * Examples of other investigational agents that would be exclusionary include supportive care agents\n* Patients receiving anti-cancer agents such as chemotherapy (e.g., temozolomide) must stop treatment 14 days prior to undergoing apheresis and remain off therapy throughout the duration of CAR T therapeutic intervention\n* Patients with active fungal, bacterial, viral, or other infection that requires intravenous antimicrobials\n\n  * Prophylactic antimicrobials are allowed\n  * Patients with active invasive fungal infection should be excluded even if the treatment is oral antimicrobials\n* History of allergy to study products\u002Fdiluents\u002Femulsions\n* Recent history (within last 3 months) of uncontrolled seizures","ALL","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","This phase I trial tests the safety, side effects, and best dose of anti-glycoprotein-A repetitions predominant (GARP) chimeric antigen receptor (CAR) T cell therapy and how well it works in treating patients with grade III or IV gliomas that have come back after a period of improvement (recurrent). CAR T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack tumor cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein, such as GARP, on the patient's tumor cells is added to the T cells in the laboratory. The special receptor is called a CAR. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain tumors. Giving anti-GARP CAR T cell therapy may be safe, tolerable, and\u002For effective in treating patients with recurrent grade III or IV gliomas.",[26,27,28,29,30,31],"Recurrent Malignant Glioma","Recurrent WHO Grade 3 Glioma","Recurrent WHO Grade 4 Glioma","WHO Grade 2 Glioma","WHO Grade 3 Glioma","WHO Grade 4 Glioma","RECRUITING","2026-05-04",{"date":35,"type":36},"2026-05-08","ACTUAL",{"date":38,"type":36},"2025-05-21",{"date":40,"type":20},"2027-05-31",{"name":42,"class":43},"Ohio State University Comprehensive Cancer Center","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":58,"conditions":59,"keywords":72,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":5},"100460636","phase-1-lutathera-for-treatment-of-recurrent-or-progressive-high-grade-cns-tumors-100460636","NCT05278208","Lutathera for Treatment of Recurrent or Progressive High-Grade CNS Tumors","Phase I\u002FII Study of Lutathera in Patients With Recurrent and\u002For Progressive High-Grade Central Nervous System Tumors and Meningiomas That Demonstrate Uptake on DOTATATE PET","All participants must meet the following inclusion and exclusion criteria. No exceptions will be given. Imaging studies to establish eligibility must be done within three weeks prior to enrollment. All other clinical evaluations to establish eligibility (except for \\[68Ga\\]Ga-DOTATATE PET) must be done within 7 days prior to enrollment.\n\n1. Screening Criteria\n\n   1.1 Diagnosis Patient must have a diagnosis of primary high-grade CNS tumor (any histopathologic diagnosis that is WHO grade III-IV) or meningioma (any histologic grade) that is recurrent, progressive, or refractory. Note that patients with DIPG (based on radiographic\u002Fclinical diagnosis) who have undergone biopsy will be eligible with histologic diagnosis of grade II-IV infiltrating glioma. All tumors must have histologic verification either at the time of diagnosis or recurrence, except for patients meningioma who have not previously undergone biopsy or resection.\n\n   Note: Refractory disease is defined as the presence of persistent abnormality on conventional MRI that is further distinguished by histology (biopsy or sample of lesion) or advanced imaging, OR as determined by the treating physician and discussed with the primary investigator prior to enrollment.\n\n   1.2 Prior Therapy Patients must have recurred\u002Fprogressed following prior standard therapy for their tumor. Note: Patients with meningioma, atypical meningioma, or anaplastic meningioma must have received at least surgical resection or radiation.\n\n   1.3 Screening Consent Participant\u002Flegal guardian is willing to sign a screening consent for \\[68Ga\\]Ga-DOTATATE PET imaging. The screening consent is to be obtained according to institutional guidelines. Assent, when appropriate, will be obtained according to institutional guidelines.\n2. Eligibility Criteria\n\n   * Phase I Age Patient must be ≥ 4 and \\\u003C12 years of age at the time of enrollment. Disease Status: Patients who participate in the efficacy expansion cohort must have bi-dimensionally measurable disease, defined as at least one lesion that can be accurately measured in at least two dimensions Patients with measurable extraneural disease only are also eligible.\n   * Phase II Age Patient must be 12 to \\\u003C\u002F=39 years at the time of enrollment.\n3. Inclusion Criteria\n\n   3.1 Uptake on \\[68Ga\\]Ga-DOTATATE PET Patients must have uptake on DOTATATE PET\u002FCT in at least one tumor lesion (corresponding to known disease) equivalent to a Krenning score ≥2 (confirmed by central radiology review).\n\n   3.2 Prior Therapy Patients must have recovered from the acute treatment related toxicities (defined as ≤ grade 1 if not defined in eligibility criteria) of all prior chemotherapy, immunotherapy, radiotherapy, or any other treatment modality prior to entering this study.\n\n   3.3 Chemotherapy Patients must have received their last dose of known myelosuppressive anticancer therapy at least 21 days prior to enrollment or at least 42 days if nitrosourea.\n\n   3.4 Investigational\u002FBiologic Agent\n\n   ●Biologic or investigational agent (anti-neoplastic): Patient must have recovered from any acute toxicity potentially related to the agent and received their last dose of the investigational or biologic agent ≥ 7 days prior to study enrollment.\n\n   For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur.\n\n   ●Monoclonal Antibodies and agents with known prolonged half-lives: Patient must have recovered from any acute toxicity potentially related to the agent and received their last dose of the agent ≥ 28 days prior to study enrollment.\n\n   3.5 Radiation\n\n   Patients must have had their last fraction of:\n   * Craniospinal irradiation or total body irradiation or radiation to \\> 50% of pelvis \\> 3 months prior to enrollment.\n   * Focal irradiation \\> 4 weeks prior to enrollment\n\n   3.6 Stem Cell Transplant\n\n   Patient must be:\n   * ≥ 6 months since allogeneic stem cell transplant prior to enrollment with no evidence of active graft vs. host disease\n   * ≥ 3 months since autologous stem cell transplant prior to enrollment\n\n   3.7 Growth Factors Patients must be off all colony-forming growth factor(s) for at least 1 week prior to enrollment (e.g. filgrastim, sargramostim or erythropoietin). Two weeks must have elapsed if patients received long-acting formulations.\n\n   3.8 Somatostatin analogs Patients must be off long-acting somatostatin analogs for at least 4 weeks and off short-acting somastatin analogs (i.e., octreotide) for at least 24 hours.\n\n   3.9 Neurologic Status\n   * Patients with neurological deficits should have deficits that are stable for a minimum of 1 week prior to enrollment, documented by a detailed neurological exam.\n   * Patients with seizure disorders may be enrolled if seizures are well controlled.\n\n   3.10 Performance Status Karnofsky Performance Scale (KPS for \\> 16 years of age) or Lansky Performance Score (LPS for ≤ 16 years of age) assessed within two weeks of enrollment must be ≥ 50. Patients who are unable to walk because of neurologic deficits, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score\n\n   3.11 Organ Function\n\n   Patients must have adequate organ and marrow function, both for eligibility for enrollment, and to begin each subsequent cycle of Lutathera, as defined below:\n   * Adequate Bone Marrow Function as defined as:\n\n     * Absolute neutrophil count ≥ 1.0 x 109 cells\u002F L\n     * Platelets ≥100 x 109 cells\u002F L (unsupported, defined as no platelet transfusion within 7 days)\n     * Hemoglobin ≥8 g\u002Fdl (may receive transfusions)\n   * Adequate Renal Function as defined as:\n\n     * Creatinine clearance or radioisotope GFR \\>70mL\u002Fmin\u002F1.73m2 OR\n     * A serum creatinine based on (Schwartz et al. J. Peds, 106:522, 1985) age\u002Fgender as follows:\n\n       1 to \\\u003C 2 years: maximum serum creatinine 0.6 mg\u002FdL for males and females. 2 to \\\u003C 6 years: maximum serum creatinine 0.8 mg\u002FdL for males and females. 6 to \\\u003C 10 years: maximum serum creatinine 1.0 mg\u002FdL for males and females. 10 to \\\u003C 13 years: maximum serum creatinine 1.2 mg\u002FdL for males and females. 13 to \\\u003C 16 years: maximum serum creatinine 1.5 mg\u002FdL for males and 1.4 mg\u002FdL for females.\n\n       ≥ 16 years: maximum serum creatinine 1.7 mg\u002FdL for males and 1.4 mg\u002FdL for females.\n   * Adequate Liver Function as defined as:\n\n     * Total bilirubin ≤ 3 times institutional upper limit of normal (ULN) for age\n     * AST(SGOT)\u002FALT(SGPT) ≤ 3 times institutional ULN\n     * Serum albumin ≥ 2g\u002FdL\n     * Coagulation parameters: INR \\\u003C1.5 times ULN and aPTT \\\u003C1.5 times ULN unless patients are receiving therapeutic anticoagulation which affects these parameters\n   * Adequate Cardiac Function as defined as:\n\n     * Ejection fraction of ≥ 55% by echocardiogram\n     * Serum electrolytes (Sodium, Potassium, Chloride) within institutional limits of normal (patients can be on enteral supplementation)\n\n   3.12 Corticosteroids Patients who are receiving dexamethasone must be on a stable or decreasing dose for at least 1 week prior to enrollment, with a maximum dexamethasone dose of 2.5mg\u002Fm2\u002Fday.\n\n   3.13 Pregnancy Status Female patients of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n\n   3.14 Pregnancy Prevention Patients of childbearing or child fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study and for at least 7 months after drug cessation in females of childbearing potential and for at least 4 months after drug cessation in males of child fathering potential.\n\n   3.15 Informed Consent The patient or parent\u002Fguardian is able to understand the consent and is willing to sign a written informed consent document according to institutional guidelines.\n4. Exclusion Criteria\n\n   4.1 Confirmed bone marrow metastatic disease Patients with confirmed metastatic disease to bone marrow are ineligible.\n\n   4.2 Presence of bulky disease Patients with bulky disease on imaging as described below are ineligible. Treating physicians are encouraged to request a rapid central imaging review to confirm fulfillment of these criteria if there are questions or concerns.\n\n   Bulky disease is defined as:\n   * Tumor with evidence of clinically significant uncal herniation or midline shift.\n   * Tumor with diameter of \\>5cm in one dimension on T2\u002FFLAIR.\n   * Tumor that in the opinion of the site investigator shows significant mass effect in either the brain or spine.\n\n   Note that patients with metastatic or multi-focal disease (with exception of bone marrow) are eligible as long as no sites of disease meet above criteria for bulky disease.\n\n   4.3 Breast-feeding Nursing mothers are excluded from this study. There is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with Lutathera.\n\n   4.4 Concurrent Illness\n   * Patients with a history of any other malignancy, except patients with a secondary brain tumor if the patient's prior malignancy has been in remission for at least 5 years from the end of treatment.\n   * Patients with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic or other organ dysfunction), that in the opinion of the investigator would compromise the patient's ability to tolerate protocol therapy, put them at additional risk for toxicity or would interfere with the study procedures or results.\n   * Patients with type I diabetes.\n\n   4.5 Concomitant Medications\n   * Patients who are receiving any other anti-cancer or investigational drug therapy are ineligible.\n   * Prior or current treatment with 177Lu-DOTATATE\u002FTOC or 90Y-DOTATATE\u002FTOC.\n\n   4.6 Prisoners will be excluded from this study.\n\n   4.7 Inability to participate: Patients who in the opinion of the investigator are unwilling or unable to return for required follow-up visits, obtain follow-up studies required to assess toxicity to therapy, or adhere to drug administration plan, other study procedures, and study restrictions.\n5. Inclusion of Women and Minorities Both males and females of all races and ethnic groups are eligible for this study.","4 Years","39 Years",{"count":55,"type":20},65,[23,57],"PHASE2","This study will evaluate the safety and efficacy of Lutathera (177Lu-DOTATATE) in patients with progressive or recurrent High-Grade Central Nervous System (CNS) tumors and meningiomas that demonstrate uptake on DOTATATE PET. The drug will be given intravenously once every 8 weeks for a total of up to 4 doses over 8 months in patients aged 4 to \\\u003C12 years (Phase I) or 12 to \\\u003C\u002F=39 years (Phase II) to test its safety and efficacy, respectively.\n\nFunding Source - FDA OOPD (grant number FD-R-0532-01)",[60,61,62,63,64,65,26,66,67,68,69,70,71],"High Grade Glioma","Meningioma","Embryonal Tumor","Medulloblastoma","Anaplastic Ependymoma","Recurrent Diffuse Intrinsic Pontine Glioma","Recurrent Medulloblastoma","Recurrent Primary Central Nervous System Neoplasm","Refractory Diffuse Intrinsic Pontine Glioma","Refractory Malignant Glioma","Refractory Medulloblastoma","Refractory Primary Central Nervous System Neoplasm",[73,74,75],"Somatostatin Receptor","DOTATATE","Lutathera","2026-04-08",{"date":78,"type":36},"2026-04-13",{"date":80,"type":36},"2022-11-21",{"date":82,"type":20},"2033-11",{"name":84,"class":43},"Nationwide Children's Hospital",{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":21,"phases":95,"briefSummary":96,"conditions":97,"keywords":98,"overallStatus":103,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":44},"100629980","phase-1-il13r2-car-t-cells-secreting-anti-pd-l1-antibody-for-recurrent-malignant-glioma-100629980","NCT07481721","IL13Rα2 CAR-T Cells Secreting Anti-PD-L1 Antibody for Recurrent Malignant Glioma","A Multicenter, Open-Label, Non-Randomized, Single-Arm Investigator-Initiated Trial to Evaluate the Safety and Efficacy of IL13Rα2 CAR-T Cells Secreting Anti-PD-L1 Antibody in Patients With Recurrent Malignant Glioma","APIC-RG","Inclusion Criteria:\n\n* Recurrent malignant glioma (WHO grade IV)\n* Pathologically confirmed and imaging-defined recurrent glioma\n* ECOG score of 0-2\n* Age \\>=18 years\n* Male or female\n* Life expectancy \\>3 months\n\nExclusion Criteria:\n\n* Severe immune suppression or autoimmune diseases\n* Severe cardiac, liver, kidney, or other major organ dysfunction\n* Pregnant or breastfeeding women\n* Prior treatment with immune checkpoint inhibitors or other immunotherapies\n* Other conditions posing significant risk to the patient or preventing adherence to the study protocol",{"count":94,"type":20},24,[23],"This clinical study is designed to evaluate the safety and efficacy of IL13Rα2 CAR-T cells secreting anti-PD-L1 antibody in patients with recurrent malignant glioma. This trial is a multicenter, open-label, non-randomized, single-arm investigator-initiated trial (IIT). Patients who have recurrent malignant glioma will receive IL13Rα2 CAR-T cell therapy and will be monitored for safety, adverse events (AEs), and efficacy outcomes, including overall survival (OS) and progression-free survival (PFS). The study will help assess the potential of this innovative therapy in the treatment of glioma and its ability to control tumor growth by targeting both IL13Rα2 and PD-L1.",[26],[99,100,26,101,102],"IL13Rα2 CAR-T","PD-L1-secreting CAR-T","Cell Therapy","Immunotherapy","NOT_YET_RECRUITING","2026-03-13",{"date":106,"type":36},"2026-03-19",{"date":108,"type":20},"2026-05-01",{"date":110,"type":20},"2027-12-31",{"name":112,"class":43},"Ming Yang",{"id":114,"slug":115,"hasResults":11,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":21,"phases":122,"briefSummary":123,"conditions":124,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":44},"100354565","phase-1-msc-dnx-2401-in-treating-patients-with-recurrent-high-grade-glioma-100354565","NCT03896568","MSC-DNX-2401 in Treating Patients With Recurrent High-Grade Glioma","Phase I Clinical Trial of Allogeneic Bone Marrow Human Mesenchymal Stem Cells Loaded With A Tumor Selective Oncolytic Adenovirus, DNX-2401, Administered Via Intra-Arterial Injection in Patients With Recurrent High-Grade Glioma","Inclusion Criteria:\n\nSubjects must meet the following inclusion criteria to be eligible and enroll:\n\n1. Subjects must be willing and able to provide informed consent, undergo and comply with all study assessments, and adhere to the protocol schedule.\n2. Patients with recurrent malignant GBM or gliosarcoma will be eligible. Patients with recurrent anaplastic astrocytoma with wild-type IDH-1 gene will also be eligible if there is a significant enhancing mass on MRI (≥1.0 cm in diameter with upper limit of 5 cm maximal diameter) because their prognosis\u002Fbehavior is similar to GBM. Subjects with an initial diagnosis of an IDH-mutant grade 2 or 3 astrocytoma are also eligible at recurrence if a biopsy at recurrence is determined to be IDH-mutant grade 4 astrocytoma, and there is a significant enhancing mass on MRI (≥1.0 cm in diameter with upper limit of 5 cm maximal diameter). A pathology report constitutes adequate documentation of histology for study inclusion.\n3. Patients must show unequivocal evidence for tumor recurrence or progression by MRI scan after failing prior surgical resection, biopsy, chemotherapy or radiation. A baseline MRI must be performed within 24 days prior to registration. Biopsy is encouraged at the time of recurrence if it is unclear that there is recurrent tumor. However, biopsy is not required if the practicing physician thinks that there is adequate radiographic and clinical evidence for recurrence.\n4. Male or female patients ≥ 18 years of age.\n5. Patients must be able to undergo endovascular treatment based on Doppler studies showing ICA that is less than 50% occluded.\n6. For patients undergoing resection for biological endpoints, tumors must be surgically resectable at the time of baseline evaluation and craniotomy for tumor resection is indicated as part of their standard medical care.\n7. Tumors must be ≥1.0 cm in diameter with upper limit of 5 cm maximal diameter.\n8. Patients must have a Karnofsky performance score ≥ 70.\n9. Patients must have a life expectancy of at least 16 weeks.\n10. Patients must have adequate bone marrow function (absolute granulocyte count \\> 1,500 and platelet count of \\> 75,000), adequate liver function (SGPT and SGOT and bilirubin \\\u003C 2 times institutional normal ranges), and adequate renal function (creatinine \\\u003C 2.0 times institutional normal) prior to starting therapy.\n11. Prothrombin time\u002Finternational normalized ratio (PT\u002FINR) or partial thromboplastin time (PTT) ≤ 1.5x ULN.\n12. Subjects who have received the following chemotherapies must have completed them within the following time periods prior to Baseline\u002FDay 0 of hMSC-DNX2401 delivery with recovery from any drug-related toxic effects to Grade 1, or less, severity:\n\n    * Four weeks from cytotoxic agents (3 weeks from procarbazine or Temozolomide, 2 weeks from vincristine)\n    * 6 weeks from nitrosoureas (CCNU, BCNU)\n    * Four weeks from any targeted investigational agent\n    * One week from non-cytotoxic agents\n13. This study was designed to include women and minorities, but was not designed to measure differences of intervention effects. Males and females will be recruited with no preference to gender.\n14. No exclusion to this study will be based on race. Minorities will actively be recruited to participate. The malignant glioma patient population treated at MDACC over the past year is as follows:\n\n    * American Indian or Alaskan Native - 0\n    * Asian or Pacific Islander - \\\u003C2%\n    * Black, not of Hispanic Origin - 3%\n    * Hispanic - 6%\n    * White, not of Hispanic Origin - 88%\n    * Other or Unknown - 2%\n    * Total - 100%\n15. Patients must be 8 weeks from radiotherapy to minimize the potential for MRI changes related to radiation necrosis that might be misdiagnosed as progression of disease, or 4 weeks if a new lesion, relative to the pre-radiation MRI, develops that is outside the primary radiation field (beyond 80% isodose line). However, if a biopsy is undertaken prior to these times and this biopsy documents histological evidence for recurrent disease, then patients will be eligible regardless of the time after radiation.\n16. Patients must be willing to forego other cytotoxic and non-cytotoxic drug or radiation therapy against the tumor while enrolled in the study.\n17. Women of childbearing potential must have a negative urine or serum pregnancy test at screening.\n18. Subjects and their partners must be willing to use effective birth control during the study and for up to 6 months following administration of hMSC-DNX2401. Birth control that is acceptable to use in this study:\n\n    * Using twice the normal protection of birth control (i.e., double-barrier) by using a condom AND spermicidal jelly or foam, or a diaphragm AND spermicidal jelly or foam. A spermicidal jelly or foam must be used in addition to a barrier method (e.g., condom or diaphragm)\n    * Birth control pills (\"The Pill\")\n    * Depot or injectable birth control\n    * IUD (Intrauterine Device)\n    * Birth Control Patch (e.g., Othro Evra®)\n    * NuvaRing®\n    * Surgical sterilization (i.e., tubal ligation or hysterectomy for women or vasectomy for men)\n\nExclusion Criteria:\n\n1. Histology other than GBM, gliosarcoma, IDH wild-type astrocytoma grade III or IDH-mutant astrocytoma grade 4.\n2. Tumor foci detected below the tentorium or beyond the cranial vault.\n3. Tumor within the posterior fossa.\n4. Tumor with leptomeningeal spread.\n5. Difficulty in obtaining vascular access for percutaneous procedure.\n6. Ipsilateral carotid stenosis (\\>50%, by Doppler studies).\n7. Thrombophilias or primary hematological diseases.\n8. Transfusions or medications (G-CSF) to treat pancytopenia or other hematological conditions \\\u003C 28 days prior to Baseline\u002FDay 0\u002FhMSC-DNX2401 administration.\n9. Biologic\u002Fimmunotherapy within 2 weeks of baseline.\n10. Clinical or laboratory evidence of inflammatory and\u002For autoimmune disorders.\n11. Any contraindication for undergoing MRI such as: individuals with pacemakers, epicardial pacer wires, infusion pumps, surgical and\u002For aneurysm clips, shrapnel, metal prosthesis, implants with potential magnetic properties, metallic bodies in the eyes, etc. In addition, subjects must present with tumor that is evaluable by MRI.\n12. Pregnant or nursing females.\n13. Evidence of active uncontrolled infection or unstable or severe intercurrent medical conditions. All subjects must be afebrile (i.e., \\\u003C38.0° Celsius \\[C\\]).\n14. Any medical condition that precludes surgery or endovascular treatment\n15. Alcoholism (dependency), alcohol or substance abuse within twelve (12) months prior to screening that has caused health consequences.\n16. Immunocompromised subjects or those with autoimmune conditions, active hepatitis (Liver function tests \\> 2x normal) or human immunodeficiency virus (HIV) seropositivity.\n17. Evidence of bleeding diathesis or use of anticoagulant medication or any medication that may increase the risk of bleeding that cannot be stopped prior to surgery. If the medication can be discontinued prior to DNX-2401 injection then the subject may be eligible following consultation with the Study Chair. Low weight heparin and Lovenox (enoxaparin) administered on a temporary limited basis for post procedure DVT prophylaxis is permitted.\n18. History or current diagnosis of any medical or psychological condition that in the Investigator's opinion might interfere with the subject's ability to participate or inability to obtain informed consent because of psychiatric or complicating medical problems.\n19. Encephalitis, multiple sclerosis or other central nervous system (CNS) infection or primary CNS disease that would interfere with subject evaluation.\n20. Subjects with known Li-Fraumini Syndrome or with a known germ line deficit in the retinoblastoma gene or its related pathways.\n21. Subjects with significant systemic or major illnesses including but not limited to: congestive heart failure, ischemic heart disease, cerebrovascular disease (history of strokes or TIAs in large vessel or small vessel distribution), kidney disease or renal failure, active liver disease, organ transplantation, or significant psychiatric disorder.\n22. Enrollment in a concomitant therapeutic clinical study.\n23. Any condition that prevents compliance with the protocol or adherence to therapy.\n24. For patients enrolled in the biological endpoint phase of the study, patients will be excluded if in the assessment of the surgeon, after resecting the tumor, there is high likelihood of injecting BM-hMSC-DNX2401 into the ventricles.",{"count":121,"type":20},36,[23],"This phase I trial studies best dose and side effects of oncolytic adenovirus DNX-2401 in treating patients with high-grade glioma that has come back (recurrent). Oncolytic adenovirus DNX-2401 is made from the common cold virus that has been changed in the laboratory to make it less likely to cause an infection (such as a cold). The virus is also changed to target brain cancer cells and attack them.",[125,126,127,128,26],"IDH1 wt Allele","Recurrent Anaplastic Astrocytoma","Recurrent Glioblastoma","Recurrent Gliosarcoma","2026-03-03",{"date":131,"type":36},"2026-03-05",{"date":133,"type":36},"2019-02-12",{"date":135,"type":20},"2027-09-30",{"name":137,"class":43},"M.D. Anderson Cancer Center"]