[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diffuse-midline-glioma-or-diffuse-intrinsic-pontine-glioma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diffuse-midline-glioma-or-diffuse-intrinsic-pontine-glioma":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,50,86],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":32,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":4},"100651985","phase-1-targeted-lsam-cisplatin-infusion-in-gliomas-evaluation-of-response-100651985",false,"NCT07767110","Targeted LSAM-Cisplatin Infusion in Gliomas, Evaluation of Response","Phase 1\u002F2a Study to Determine the Safety of Intratumoral Infusion of Large Surface Area Microparticle (LSAM)-Cisplatin in Participants With Diffuse Midline Glioma (DMG), Including Diffuse Intrinsic Pontine Glioma (DIPG)","TIGER-1","Inclusion Criteria:\n\n* Aged 3 to ≤ 21 years.\n* Diagnosis of diffuse midline glioma (DMG), including diffuse intrinsic pontine glioma (DIPG), based on characteristic magnetic resonance imaging (MRI) findings and\u002For histopathologic confirmation.\n* Prior radiation treatment must have included focal radiation therapy per institutional standard of care and must have been initiated within 6 weeks of diagnosis.\n* At least 4 weeks, but no more than 12 weeks, post-completion of radiotherapy treatment.\n* A standard of care post-radiation magnetic resonance imaging (MRI) performed 4 to 6 weeks after radiation therapy is required for confirmation of eligibility.\n* Performance status \\[Karnofsky Performance Scale or Lansky Performance Score\\] within 14 days of Day 1 ≥ 60.\n* Absence of other significant medical condition.\n* A legal parent\u002Fguardian and\u002For participant must be able to understand and be willing to sign a written informed consent and\u002For assent document, as appropriate.\n\nExclusion Criteria:\n\n* Untreated symptomatic hydrocephalus at the time of consent, has metastatic or disseminated disease, or leptomeningeal disease.\n* Magnetic resonance imaging (MRI) findings that preclude stereotactic procedure.\n* Intercurrent illnesses or conditions which preclude participation: active systemic infections, autoimmune disease requiring systemic immunomodulation, active or uncontrolled seizure disorder, central nervous system (CNS) vasculopathy or aneurysms, Grade ≥3 cardiac dysfunction, Fridericia-corrected QT interval (QTcF) ≥470 ms.\n* Abnormal organ function:\n\n  * Renal insufficiency: glomerular filtration rate (GFR) ≤ 60 mL\u002Fmin\u002F1.73m² (with Schwartz equation)\n  * Hepatic dysfunction: aspartate aminotransferase (AST) \u002F alanine aminotransferase (ALT) ≤ 1.5 x upper limit of normal (ULN) and 3 x upper limit of normal (ULN) in the presence of liver metastases; or bilirubin ≤ 1.5 x upper limit of normal (ULN) and 3 x upper limit of normal (ULN) in the presence of Gilbert disease\n  * Bone marrow suppression:\n\n    * absolute neutrophil count (ANC) \\\u003C 1,000\u002FμL\n    * platelets \\\u003C 100,000\u002FμL\n  * Coagulopathy or international normalized ratio (INR) \\> 1.5\n* Receiving any anticoagulants or antiplatelet drugs; any drugs known to cause ototoxicity and nephrotoxicity; receiving any other tumor-directed therapy.\n* Known allergy or hypersensitivity to the study agent (including cisplatin and diluent components).\n* Female participants of childbearing potential must not be pregnant or breast-feeding.","ALL","3 Years","21 Years",{"count":21,"type":22},20,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","Open-label, dose-escalating, Phase 1\u002F2a trial of Large Surface Area Microparticle (LSAM)-Cisplatin to treat participants with diffuse midline glioma (DMG), including diffuse intrinsic pontine glioma (DIPG), via stereotactic infusion under intraoperative magnetic resonance imaging (MRI) guidance.",[29,30,31],"Diffuse Midline Glioma (DMG)","Diffuse Intrinsic Pontine Glioma (DIPG)","Diffuse Midline Glioma or Diffuse Intrinsic Pontine Glioma",[33,34,35,36,37],"Diffuse Midline Glioma","Diffuse Intrinsic Pontine Glioma","H3 K27 Mutation","Pediatric Brain Tumor","Convection-enhanced delivery","NOT_YET_RECRUITING","2026-08-14",{"date":41,"type":42},"2026-08-18","ACTUAL",{"date":44,"type":22},"2026-12",{"date":46,"type":22},"2029-12",{"name":48,"class":49},"NanOlogy, LLC","INDUSTRY",{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":23,"phases":60,"briefSummary":61,"conditions":62,"keywords":68,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":4},"100644286","phase-1-ngfus-nivo-neuronavigation-guided-focused-ultrasound-with-nivolumab-in-relapsed-and-progressive-dmg-and-other-high-grade-brain-tumors-100644286","NCT07664176","NgFUS NIVO: NeuroNavigation-Guided Focused Ultrasound With Nivolumab in Relapsed and Progressive DMG and Other High Grade Brain Tumors","A Safety and Feasibility Study of NeuroNavigation-Guided Low Intensity Focused Ultrasound With Microbubbles to Enhance Nivolumab Delivery for the Treatment of Relapsed and Progressive Diffuse Midline Glioma and Other High Grade Brain Tumors","Inclusion Criteria:\n\n* Age ≥ 3 and ≤ 25 years.\n* Diagnosis of brainstem DMG\u002FDIPG or any high-grade brain tumor.\n\n  * Group A: Relapsed or progressive brainstem DMG.\n  * Group B: Relapsed or progressive high-grade intracranial brain tumor requiring surgical resection.\n* Lansky\u002FKarnofsky rating ≥ 60.\n* Patients must have received at least one line of prior therapy upfront for their disease.\n* At least four weeks from radiation therapy, prior immunotherapy, or monoclonal antibody therapy.\n* At least 2 weeks from prior myelosuppressive chemotherapy and post nadir meeting organ function criteria.\n* At least 1 week or 5 half-lives (whichever is longer) from last targeted therapy.\n* If on steroids, stable or decreasing dose for at least 7 days prior to study entry and ≤ 0.4 mg\u002Fm2\u002Fday of dexamethasone or equivalent.\n* Stable or improving neurological status for 7 days prior to study entry.\n* Organ function:\n\n  * Absolute Neutrophil Count (ANC) ≥750\u002FμL.\n  * Absolute Lymphocyte Count (ALC) \\>500\u002FμL.\n  * Platelets ≥75K, unsupported.\n  * Coagulation studies: PT and PTT \\\u003C1.5 ULN and INR (\\\u003C1.5).\n  * Bilirubin ≤1.5x upper limit of normal (ULN).\n  * AST\u002FALT ≤5x ULN.\n  * Serum creatinine within normal limits for age.\n  * Pulse oximetry \\>93% on room air.\n  * Ejection Fraction (EF) above institutional lower limit of normal (LLN).\n* For females of childbearing potential (FOCBP): negative pregnancy test within 7 days of study entry.\n* Patients of childbearing or child-fathering potential must agree to use contraceptive measures for at least 5 months following nivolumab infusion.\n* Patient or parent\u002Fguardian capable of providing informed consent.\n\nExclusion Criteria:\n\n* Symptoms and signs of increased intracranial pressure.\n* Patients with metallic ventricular peritoneal shunts. Subjects with nonmetallic VP shunts or similar will have a technical evaluation of the screening non-contrast CT scan of the head. During the mapping of the target area, if the technical NaviFUS specialist determines that the patient cannot be treated within the safety limits of the system, the patient will not be eligible and will be considered a screen failure.\n* Tumor presenting with the following imaging characteristics:\n\n  * Evidence of uncal herniation.\n  * Edema and\u002For mass effect that causes hydrocephalus.\n  * Significant areas of necrosis within the tumor that the neurosurgeon feels cannot be avoided during the ultrasound sonication.\n  * Evidence of a significant new hemorrhage. Area of microhemorrhage (defined as less than 5 mm in diameter) in the treatment area can be acceptable but requires the review of the neurosurgeon.\n  * Containing calcifications in the focused ultrasound sonication beam path and system tools cannot tailor the treatment around these calcification spots.\n  * Patients who are deemed to have overly bulky tumor by the PI of the study.\n* The sonication pathway to the tumor involves:\n\n  * More than 30% of the skull area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp.\n  * Clips, or other non-MRI compatible metallic implanted objects in the skull or the brain, except for shunts.\n* Patients receiving anti-coagulant therapy, or medications known to increase risk of hemorrhage, (e.g., ASA, non-steroidal anti-inflammatory drugs \\[NSAIDs\\], statins). There is no required washout for eligibility assessment, but patients should be off agents for at least 3 days at the time of procedure or until 5 half-lives of the agent, whichever is longer.\n* History of a bleeding disorder, coagulopathy or with a history of clinically significant spontaneous tumor hemorrhage.\n* Cerebral or systemic vasculopathy, including intracranial thrombosis, vascular malformation, cerebral aneurysm, or vasculitis.\n* Immunosuppression (corticosteroids to prevent\u002Ftreat brain edema are permitted).\n* Patients with uncontrolled HIV.\n* Active seizure disorder or epilepsy (clinically significant seizures despite medical treatment) within four weeks prior to first cycle\u002FNaviFUS BBBO procedure captured by history.\n* Known sensitivity to gadolinium-based contrast agents.\n* Known sensitivity to Lumason® ultrasound contrast agent or known hypersensitivity to sulphur hexafluoride microsphere or its components, e.g., polyethylene glycol.\n* Patients unable to fit comfortably into the MRI scanner (generally \\>250 lbs.).\n* Evidence of cranial or systemic infection.","25 Years",{"count":59,"type":22},30,[25],"This is an open-label phase 1 safety and feasibility study evaluating a novel combination therapy for progressive and relapsed diffuse midline glioma (DMG) and other progressive and relapsed high-grade brain tumors. This study combines intravenous nivolumab therapy infused following transient blood-brain barrier opening (BBBO) using low-intensity focused ultrasound with microbubble (LIFU-MB) treatment using NeuroNavigation-Guided Focused Ultrasound (NgFUS).\n\nThere are two groups in this study:\n\n* Group A: Patients with relapsed or progressive diffuse midline glioma in the brainstem\n* Group B: Patients with relapsed or progressive high grade brain tumor that clinically require surgical resection\n\nThe primary outcome is to evaluate the safety and feasibility of 3 cycles of nivolumab with BBB disruption using NgFUS with microbubbles in pediatric patients with progressive or relapsed brainstem DMG or with high grade brain tumors after surgery. Secondary outcomes include preliminary efficacy and immunological effects.",[31,63,64,65,66,67],"High Grade Gliomas","Medulloblastoma Recurrent","Ependymoma Recurrent","Atypical Teratoid\u002FRhabdoid Tumor (ATRT) of the CNS","Brain Tumor Recurrent",[69,70,33,71,34,72,73,74,75],"Focused Ultrasound","Pediatrics","DMG","DIPG","High Grade Glioma","HGG","Nivolumab","2026-07-22",{"date":78,"type":42},"2026-07-23",{"date":80,"type":22},"2026-08-24",{"date":82,"type":22},"2030-12",{"name":84,"class":85},"Children's National Research Institute","OTHER",{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":4,"eligibilityCriteria":92,"healthyVolunteers":11,"sex":17,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":4,"studyType":23,"phases":96,"briefSummary":97,"conditions":98,"keywords":99,"overallStatus":102,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":112},"100631475","phase-1-h3k27m-specific-immune-effector-cells-targeting-dmgdipg-100631475","NCT07501156","H3K27M-specific Immune Effector Cells Targeting DMG\u002FDIPG","H3K27M-specific Engineered Immune Effectors (EIE) Targeting Diffuse Midline Glioma\u002FDiffuse Intrinsic Pontine Glioma","Inclusion Criteria:\n\n1. Abilities to understand and the willingness to provide written informed consent;\n2. ≥ 2 and ≤ 70 years old;\n3. Recurrent or refractory diffuse midline glioma or diffuse intrinsic pontine glioma patients with confirmed H3K27M mutation and documented lesions. Patients have received standard care of medication, such as gross total resection with concurrent radio-chemotherapy (\\~54 - 60 Gy, TMZ). Patients must either not be receiving dexamethasone or receiving ≤ 4 mg\u002Fday at the time of leukopheresis;\n4. Karnofsky performance score (KPS) ≥ 60;\n5. Life expectancy \\>3 months;\n6. Satisfactory bone marrow, liver and kidney functions as defined by the following: absolute neutrophile count ≥ 1500\u002Fmm\\^3; hemoglobin \\> 10 g\u002FdL; platelets \\> 100000 \u002Fmm\\^3; Bilirubin \\\u003C 1.5×ULN; alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\\u003C 2.5×ULN; creatinine \\\u003C 1.5×ULN;\n7. Peripheral blood absolute lymphocyte count must be above 0.8×10\\^9\u002FL;\n8. Satisfactory heart functions;\n9. Must be willing to follow the instructions of doctors; Women of reproductive potential (between 15 and 49 years old) must have a negative pregnancy test within 7 days of study start. Male and female patients of reproductive potential must agree to use birth control during the study and 3 months post study.\n\nExclusion Criteria:\n\n1. A prior history of gliadel implantation 4 weeks before this study start or currently receiving antibody based therapies;\n2. HIV positive;\n3. Tuberculosis infection not under control;\n4. History of autoimmune disease, or other diseases require long-term administration of steroids or immunosuppressive therapies;\n5. History of allergic disease, or allergy to immune cells or study product;\n6. Patients already actively enrolled in other immune cell clinical study; Patients, in the opinion of investigators, may not be eligible or not able to comply with the study.","2 Years","70 Years",{"count":59,"type":22},[25,26],"The purpose of this study is to assess the feasibility, safety and efficacy of H3K27M-specific engineered immune effector (EIE) therapy in patients with high-risk, H3K27M-positive diffuse midline glioma\u002Fdiffuse intrinsic pontine glioma. Another goal of the study is to learn more about the function of the anti-H3K27M EIE cells and their persistency in patients.",[31],[100,72,101],"EIE","H3K27M","RECRUITING","2026-03-24",{"date":105,"type":42},"2026-03-30",{"date":107,"type":42},"2026-03-18",{"date":109,"type":22},"2030-04-30",{"name":111,"class":85},"Shenzhen Geno-Immune Medical Institute",1]