[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"atypical-teratoidrhabdoid-tumor-atrt-of-the-cns\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:atypical-teratoidrhabdoid-tumor-atrt-of-the-cns":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,83],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100627318","phase-2-study-of-novel-therapies-for-young-people-with-recurrentprogressive-atypical-teratoid-rhabdoid-tumor-atrt-100627318",false,"NCT07447076","Study of Novel Therapies for Young People With Recurrent\u002FProgressive Atypical Teratoid Rhabdoid Tumor (ATRT)","A Platform Study of Novel Therapies for Children, Adolescents and Young Adults With Recurrent\u002FProgressive Atypical Teratoid Rhabdoid Tumor (ATRT)","Inclusion Criteria:\n\n* In addition to the below, investigators are to refer to arm-specific inclusion criteria in the appendix.\n\n  * Participants must have a pathologic diagnosis of central nervous system (CNS) ATRT, with confirmation of SWI\u002FSNF-related, matrix-associated, actin-dependent regulator of chromatin, subfamily b, member 1 (SMARCB1) (INI1) loss by immunohistochemistry (IHC) and\u002For biallelic loss of function of SMARCB1 by molecular report. Loss of SWI\u002FSNF Related, Matrix Associated, Actin Dependent Regulator of Chromatin, Subfamily A, Member 4 (SMARCA4) as confirmed by IHC or molecular report is also acceptable but requires study chair approval.\n  * Participants must have confirmation of methylation report, co-enrollment on PNOC-030 or sufficient tumor tissue available for methylation-based subgrouping\n  * Participants must have recurrent or progressive ATRT.\n  * Participants age must be ≥1 and ≤ 39 years at the time of study enrollment. Please refer to arm specific inclusion criteria for potential variations in lower age eligibility limit.\n  * Prior Therapy: Participants must have fully recovered from the acute effects of prior anti-cancer therapy, and the following wash-out periods need to be observed prior to enrollment:\n* Systemic myelosuppressive therapy: ≥ 21 days after the last dose (42 days for nitrosoureas or mitomycin C).\n* Intrathecal\u002Fintraventricular chemotherapy: \\> 7 days after the last dose.\n* Small molecule\u002Ftargeted\u002Fbiologic agent: ≥ 7 days after the last dose.\n* Monoclonal antibodies: ≥ 21 days after the last dose. Other non-myelosuppressive anti-cancer agents: ≥ 3 drug half-lives after the last dose.\n* CAR-T cell therapy (systemic or intraventricular): \\> 21 days.\n\n  • Previous radiotherapy. Participants will be eligible following radiotherapy, if they meet the following criteria:\n* Previous craniospinal or total body radiotherapy: Participants must have received their last fraction ≥ 12 weeks prior to enrollment and have evidence of progressive\u002Frecurrent evaluable disease post radiation.\n* Previous focal radiotherapy to target lesions: Participants must have received their last fraction to target lesions ≥12 weeks prior to enrollment and have evidence of progressive\u002Frecurrent evaluable disease post radiation; investigators are reminded to review potentially eligible cases to avoid confusion with pseudo-progression.\n* Focal radiotherapy to non-target lesions: Participants may have received radiotherapy to nontarget lesions as long as the last fraction was \\> 14 days prior to enrollment. Participants must have at least one non-irradiated lesion that is evaluable for response.\n\n  * Performance Score: Karnofsky ≥ 50 for participants \\> 16 years of age and Lansky ≥ 50 for participants ≤ 16 years of age. Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.\n  * Corticosteroids: Participants who are receiving corticosteroids must be on a stable or decreasing dose for at least 1 week prior to enrollment. Please also refer to arm-specific inclusion criteria for potential variations in steroid limitations.\n  * Organ Function Requirements.\n\nAdequate Bone Marrow Function Defined as:\n\n* Peripheral absolute neutrophil count (ANC) ≥ 750\u002Fmm3\n* Platelet count ≥ 75,000\u002Fcubic millimeters (mm3) (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment).\n\nAdequate Renal Function Defined as:\n\n* Serum creatinine ≤ 1.5 Upper Limit Normal (ULN) based on age and gender\n\nAdequate Liver Function Defined as:\n\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age; in presence of Gilbert's syndrome, total bilirubin \\\u003C 3 x ULN or direct bilirubin \\\u003C 1.5 x ULN\n* Alanine aminotransferase (ALT) ≤ 3 x ULN\n* Aspartate aminotransferase (AST) ≤ 3 x ULN\n\nAdequate Neurologic Function Defined as:\n\n* Participants with seizure disorder may be enrolled if well controlled. See arm-specific recommendations for potential interactions between anticonvulsant agent(s) with study drug.\n\n  * Effect on the developing human fetus Recommendations on the potential effect of interventional agents on the developing human fetus will be specified in each study arm's details of therapeutic agents. Unless otherwise specified, the effects of study interventions should be considered potentially teratogenic. Thus, 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 treatment and four months after its completion. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, or should a male participant's partners become pregnant during study participation, they should inform the treating physician immediately.\n  * A legal parent\u002Fguardian or patient must be able to understand, and willing to sign, a written informed consent and assent document, as appropriate.\n  * Participants must enroll on Pediatric Neuro-oncology Consortium (PNOC) COMP if PNOC COMP is open to accrual at the enrolling institution.\n\nExclusion Criteria:\n\n* Evidence of synchronous tumors or other extra-CNS malignancy\n* Participants who are receiving any other investigational agents\n* Participants who are currently receiving other anti-cancer agents\n* Participants with uncontrolled infection or other uncontrolled systemic illness\n* Female participants of childbearing potential who are pregnant or breast-feeding. Female participants of childbearing potential must have a negative serum or urine pregnancy test prior to the start of therapy and throughout study treatment.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition as the intended treatment regimen, as detailed in that arm's treatment description.\n\nArm A\n\nInclusion Criteria:\n\n* Subjects must meet all inclusion criteria for the overall study.\n* Patients must be evaluable per Response Assessment in Pediatric Neuro-Oncology (RAPNO) criteria for medulloblastoma and other leptomeningeal seeding tumors to be evaluated for the primary endpoint (Warren et al. 2018); patients with evaluable but non-measurable disease, including leptomeningeal disease or positive CSF cytology only are eligible.\n\nPatients with recurrent or progressive ATRT who receive surgery only for their disease progression and do not have evaluable disease may be eligible for study treatment but would not be included towards the primary efficacy endpoint (to be discussed with study chairs).\n\n* Subjects must be able to swallow intact capsules.\n* Adequate Metabolic Function Defined as:\n\n  * Non-fasting glucose ≤ 140 milligrams per deciliter (mg\u002FdL) without the use of antihyperglycemic agents.\n  * If non-fasting glucose \\> 140 mg\u002FdL, a fasting glucose should be done. If fasting glucose ≤ 125 mg\u002FdL without the use of antihyperglycemic agents, participant will meet adequate metabolic function criteria.\n  * Triglycerides of \\\u003C 300 mg\u002Fdl and total cholesterol of \\\u003C 300 mg\u002Fdl - can be on lipid lowering medications as needed to achieve.\n* Adequate Cardiac Function Defined as:\n\n  * Electrocardiogram (ECG) must be obtained to verify the Corrected QT Interval (QTC). If an abnormal reading is obtained, the ECG should be repeated in triplicate.\n  * QTC \\\u003C 470 millisecond (msec)\n\nArm A\n\nExclusion Criteria:\n\nIn addition to not meeting any of the exclusion criteria of the overall study, participation on arm A will also require that subjects do not meet any of the following:\n\n* Previous exposure to gemcitabine or paxalisib\n* Concomitant use of an antihyperglycemic agent (e.g. metformin)\n* Chronic diarrhea greater than Grade 2","ALL","1 Year","39 Years",{"count":20,"type":21},29,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a multi-treatment arm study that will be conducted through the Pacific Pediatric Neuro-oncology Consortium (PNOC).The study will assess the safety and efficacy of novel therapies and combinatorial strategies for participants with recurrent or progressive ATRT.",[27,28],"Recurrent Atypical Teratoid\u002FRhabdoid Tumor","Atypical Teratoid\u002FRhabdoid Tumor (ATRT) of the CNS",[30],"Novel therapies","RECRUITING","2026-06-18",{"date":34,"type":35},"2026-06-23","ACTUAL",{"date":37,"type":35},"2026-06-17",{"date":39,"type":21},"2036-12-31",{"name":41,"class":42},"Sabine Mueller, MD, PhD","OTHER",2,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":64,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"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.","3 Years","25 Years",{"count":54,"type":21},30,[56],"PHASE1","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.",[59,60,61,62,28,63],"Diffuse Midline Glioma or Diffuse Intrinsic Pontine Glioma","High Grade Gliomas","Medulloblastoma Recurrent","Ependymoma Recurrent","Brain Tumor Recurrent",[65,66,67,68,69,70,71,72,73],"Focused Ultrasound","Pediatrics","Diffuse Midline Glioma","DMG","Diffuse Intrinsic Pontine Glioma","DIPG","High Grade Glioma","HGG","Nivolumab","NOT_YET_RECRUITING",{"date":76,"type":35},"2026-06-24",{"date":78,"type":21},"2026-06-01",{"date":80,"type":21},"2030-12",{"name":82,"class":42},"Children's National Research Institute",{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":22,"phases":93,"briefSummary":94,"conditions":95,"keywords":105,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":124},"100599631","phase-1-gpc2-car-t-cell-therapy-for-relapsed-or-refractory-medulloblastoma-in-children-and-young-adults-100599631","NCT07087002","GPC2-CAR T Cell Therapy for Relapsed or Refractory Medulloblastoma in Children and Young Adults","Phase I Clinical Trial of GPC2 Chimeric Antigen Receptor T (GPC2-CAR T) Cells for Relapsed or Refractory Medulloblastoma in Children and Young Adults","Inclusion Criteria:\n\n1. Diagnosis: Histologically confirmed diagnosis of medulloblastoma or other primary CNS embryonal tumor according to 2021 CNS WHO Classification (5th edition)\n\n   * Other acceptable CNS embryonal tumors include:\n   * Embryonal Tumor with Multilayered Rosettes (ETMR)\n   * Pineoblastoma\n   * Atypical Teratoid\u002FRhabdoid Tumor (ATRT) of the CNS\n   * CNS neuroblastoma, FOXR2-activated\n   * CNS Embryonal Tumor NOS\n2. Recurrent\u002FRefractory Disease: History of relapsed and\u002For recurrent disease defined as tumor progression or recurrence following initial diagnosis and upfront treatment with curative intent, or failure to achieve disease control with standard curative-intent therapy.\n3. GPC2 Positive: H-score ≥ 100 by IHC staining performed on the (Prescreening Protocol IRB-78780, PI: Katherine Ryan, DO) at Stanford Clinical Anatomic Pathology Lab for GPC2 from a tumor sample any time since initial diagnosis.\n4. Evaluable Disease: Evaluable disease as per radiographic findings and\u002For positive cerebrospinal fluid cytology within 28 days of enrollment.\n5. Patients with VP shunts: Patients with pre-existing ventriculo-peritoneal (VP) shunt devices must have a programmable shunt device to enroll on this study. A VP shunt is not a requirement for this study.\n6. Prior therapy: No limit to the number of prior treatment regimens. Toxicities due to prior therapy must be stable or recovered to ≤ Grade 1 (except for clinically non-significant toxicities such as alopecia, nutritional support measures, electrolyte abnormalities, or those not impacting the investigator's ability to assess treatment emergent toxicities).\n\n   At time of enrollment, subjects are on track to meet the required therapy wash out period(s) prior to apheresis.\n\n   a. At least 6 weeks following craniospinal radiation therapy. i. At least 14 days wash-out needed following small volume radiotherapy (i.e., Stereotactic Radiosurgery (SRS)).\n\n   b. At least 21 days or 5 half-lives (whichever is shorter) must have elapsed since any prior systemic therapy, except for systemic inhibitory\u002Fstimulatory immune checkpoint therapy, which requires 5 half-lives.\n\n   c. At least 28 days following bevacizumab treatment. d. At least 30 days following any investigational drug. e. At least 12 weeks following systemic inhibitory or stimulatory immune checkpoint therapy.\n7. Age: ≥ 12 months to ≤ 30 years of age at time of enrollment The first 3 subjects treated with GPC2-CAR T cells must be ≥ 3 years old at time of infusion\n8. Performance Status: Subjects ≥ 16 years of age must have Karnofsky ≥ 60%. Subjects \\\u003C 16 years of age must have Lansky scale 60%; or ECOG performance status ≤ 2 (see Section 11.3).\n9. Normal Organ and Marrow Function \\[supportive care is allowed per institutional standards, i.e., filgrastim, transfusion\\]\n\n   1. Hemoglobin ≥ 8 g\u002FdL\n   2. Absolute Neutrophil Count (ANC) ≥ 1,000\u002FμL\n   3. Platelet count ≥ 75,000\u002FμL, with no platelet transfusion within 96 hours prior to enrollment\n   4. Absolute lymphocyte count (ALC) ≥ 150\u002FμL\n   5. PT\u002FINR, PTT ≤ 1.5 x ULN for age\n\n      Adequate renal, hepatic, cardiac, and pulmonary function defined as:\n   6. Serum creatinine \\\u003C 1.5 x ULN for age and gender, OR creatinine clearance or GFR (radioisotope or iothalamate) ≥ 70 mL\u002Fmin\u002F1.73 m2\n   7. Serum ALT or AST ≤ 3x ULN\n   8. Total bilirubin ≤ 1.5 mg\u002FdL, unless subject has Gilbert's Syndrome\n   9. Cardiac ejection fraction ≥ 45%\n   10. No evidence of physiologically significant pericardial effusion as determined by an ECHO\n   11. No clinically significant ECG findings\n   12. No clinically significant pleural effusion\n   13. Pulse oximetry ≥ 92% on room air, OR forced vital capacity ≥ 50% of predicted value\n10. Not Pregnant: Females of childbearing potential must have a negative pregnancy test.\n11. Contraception: Subjects of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study and for four (4) months after receiving the preparative regimen or for as long as CAR T cells are detectable in peripheral blood.\n12. Must provide informed consent. All subjects ≥ 18 years of age must be able to give informed consent. For subjects \\\u003C18 years old or adults with limited decision-making capacity, their legal authorized representative (LAR) (i.e., parent or guardian) must give informed consent. Pediatric subjects will be included in age-appropriate discussion and assent will be obtained for those \\> 7 years of age, when appropriate. If a minor becomes of age during participation of this study, he\u002Fshe will be asked to reconsent as an adult.\n\nExclusion Criteria\n\n1. Any patient with metastatic disease OUTSIDE the CNS.\n2. Unwilling or unable, in the investigator's judgement, to have a CSF reservoir (Ommaya or Rickham) placed. Does not apply to subjects who have a pre-existing device suitable for ICV delivery of CAR T cells and ICP monitoring.\n3. Clinical evidence of active\u002Fon-going significant increased intracranial pressure (i.e., impending herniation) or uncontrolled seizures.\n4. Prior receipt of a chimeric antigen receptor (CAR)-based therapy.\n5. Currently receiving anticoagulation therapy.\n6. Known history of infection with HIV or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive).\n\n   EXCEPTION: A history of hepatitis B or hepatitis C is permitted if the viral load is undetectable per quantitative PCR and\u002For nucleic acid testing.\n7. Pregnancy or breastfeeding in a postpartum female.\n8. Known sensitivity or allergy to any agents\u002Freagents used in this study.\n9. History of prior other malignancy. EXCEPTION: Previously diagnosed and definitively treated more than 5 years prior to enrollment or whose prognosis is deemed good enough to not warrant surveillance.\n10. Primary immunodeficiency or history of autoimmune disease (e.g., Crohn's, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression\u002Fsystemic disease modifying agents within the last 2 years.\n11. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac disease within 12 months of enrollment.\n12. Significant medical diseases or poorly controlled conditions that, in the judgement of the investigator, put the subject at an unacceptable risk of complications, including but not limited to: uncontrolled diabetes mellitus, chronic obstructive pulmonary disease, pulmonary fibrosis, clinically significant inflammatory disorders, immunodeficiency (e.g., HIV infection), immunocompromised for reasons other than malignancy (e.g., chronic corticosteroid therapy or other immunosuppressive therapy), renal failure including patients requiring dialysis, or clinically significant liver dysfunction.\n13. In the Investigator's judgment, the subject or parents\u002Fcaregivers (as required) will not be able to comply with the study procedures outlined in the study protocol including follow-up visits.","30 Years",{"count":92,"type":21},18,[56],"This is a single-site, open-label Phase 1 clinical trial evaluating the feasibility, safety, and preliminary activity of autologous GPC2-targeted chimeric antigen receptor (CAR) T cells administered via intracerebroventricular (ICV) infusion in children and young adults with relapsed or refractory medulloblastoma or other eligible Central Nervous System (CNS) embryonal tumors.",[96,97,98,99,100,101,102,28,103,104],"Medulloblastoma","Central Nervous System Embryonal Tumor","Refractory Medulloblastoma","Recurrent Medulloblastoma","Pediatric Brain Tumor","Embryonal Tumor With Multilayered Rosettes (ETMR)","Pineoblastoma","CNS Neuroblastoma","FOXR2-activated",[106,107,108,109,110,96,111,112,113,102,28,114,104],"GPC2-CAR T cells","Chimeric Antigen Receptor T cells","Intracerebroventricular CAR T","Pediatric CNS tumors","Immunotherapy","Refractory brain tumors","T cell therapy","Embryonal Tumor with Multilayered Rosettes (ETMR)","CNS neuroblastoma","2026-01-26",{"date":117,"type":35},"2026-01-27",{"date":119,"type":35},"2025-08-28",{"date":121,"type":21},"2027-08",{"name":123,"class":42},"Stanford University",1]