[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"diffuse-midline-glioma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:diffuse-midline-glioma":37},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,6,0,[8,66,106,137,176,197],{"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":39,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":5},"100645242","phase-2-illuminate-a-clinical-study-evaluating-car-t-immune-cell-therapy-bcb-276-for-patients-with-diffuse-intrinsic-pontine-glioma-dipg-100645242",false,"NCT07680439","Illuminate: A Clinical Study Evaluating CAR T Immune Cell Therapy (BCB-276) for Patients With Diffuse Intrinsic Pontine Glioma (DIPG).","A Phase 2 Pivotal Study of BCB-276, a B7-H3-Specific CAR T Cell Locoregional Immunotherapy for Diffuse Intrinsic Pontine Glioma","Inclusion Criteria:\n\n* Participants must be aged 1 and ≤ 26 years and weigh ≥10kg.\n* Diagnosis of Diffuse Intrinsic Pontine Glioma (DIPG) based on imaging, with or without biopsy confirmation consistent with high-grade glioma or diffuse midline glioma\n* Able to tolerate leukapheresis and other study procedures in the opinion of the Investigator.\n* Central Nervous System (CNS) reservoir catheter present prior to first dose of study drug.\n* Participant must have completed standard radiation therapy within 6 weeks of enrollment for participation.\n* Performance Status of ≥ 60; mild to moderate restriction or better. Lansky (under 16 years of age) or Karnofsky (16 years of age or older).\n* Adequate organ function and overall clinical status to participate, including stable or improving neurologic symptoms.\n* Participants of childbearing\u002Ffathering potential must agree to use highly effective contraception from the time of enrollment through 12 months following the last T cell infusion.\n* Participants with ventriculoperitoneal (VP) shunts need to have a programable system and be able to tolerate temporary adjustment of the shunt required for study treatment.\n* Participant must meet all other health and safety criteria defined in the study protocol.\n* Participant and\u002For authorized legal representative willing to provide consent\u002Fassent for study participation, including participation in the 15-year long term follow up period.\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Previous tumor-directed therapy or treatment-directed clinical study other than standard radiation with or without temozolamide.\n* Evidence of metastatic disease.\n* Requirement of high or increasing doses of corticosteroids prior to participation.\n* Severe swallowing difficulties or other significant clinical conditions that may interfere with participation.\n* Presence of an active malignancy other than DIPG.\n* Active or uncontrolled human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection based on protocol-required laboratory testing.\n* Pregnant or breastfeeding.\n* Presence of any condition that, in the Investigator's opinion, would prohibit the participant from undergoing treatment under this protocol.","ALL","1 Year","26 Years",{"count":20,"type":21},75,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This study will evaluate BCB-276, an investigational B7-H3-targeted Chimeric Antigen Receptor (CAR) T cell therapy, in children and young adults with diffuse intrinsic pontine glioma (DIPG). DIPG is a rare and aggressive brain tumor with limited treatment options. CAR T cell therapy uses a patient's own immune cells that are changed in a laboratory to recognize and attack cancer cells. The purpose of this study is to determine whether BCB-276, when given after completion of standard radiation therapy, is safe and can improve survival for patients with DIPG.\n\nTo participate, individuals must be between 1 and 26 years of age when they join the study, have a diagnosis of DIPG, and enroll for treatment within 6 weeks of completing initial radiation therapy. Participants must not have received prior anti-cancer therapy beyond radiation with or without temozolomide prior to joining this study.\n\nBCB-276 is administered intraventricularly (into the fluid around the brain), which requires placement of a catheter for treatment. BCB-276 is given every 2 weeks at a research center over a period of several months (approximately 7-8 months). Participation includes travel to a study site, procedures to support treatment administration, sample collection, and ongoing monitoring for safety and effectiveness, with follow-up visits lasting up to about 2 years.",[27,28,29,30,31,32,33,34,35,36,37,38],"Diffuse Intrinsic Pontine Glioma","DIPG","Brain Tumor","CNS Tumor","Central Nervous System Tumor","Pediatric Cancer","Adult Cancer Patients","CNS Tumor, Childhood","CNS Tumor, Adult","Brainstem Glioma","Diffuse Midline Glioma","DMG",[40,41,42,43,44,45,46,47,48,49,50,51,52,53],"BCB-276","B7-H3-specific Chimeric Antigen Receptor [CAR] T cell therapy","B7-H3","B7-H3 CAR T","B7-H3 CAR T Cells","Chimeric antigen receptor T cells","CAR T Cell","Immunotherapy","Cell Therapy","Pediatric","Children","Adolescent","Young Adult","Adult","NOT_YET_RECRUITING","2026-06-25",{"date":57,"type":58},"2026-07-02","ACTUAL",{"date":60,"type":21},"2026-07",{"date":62,"type":21},"2030-07",{"name":64,"class":65},"BrainChild Bio, Inc","INDUSTRY",{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":78,"briefSummary":80,"conditions":81,"keywords":85,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":105},"100565240","phase-1-pep-cmv--nivolumab-for-newly-diagnosed-diffuse-midline-gliomahigh-grade-glioma-and-recurrent-diffuse-midline-gliomahigh-grade-glioma-medulloblastoma-and-ependymoma-100565240","NCT06639607","PEP-CMV + Nivolumab for Newly Diagnosed Diffuse Midline Glioma\u002FHigh-grade Glioma and Recurrent Diffuse Midline Glioma\u002FHigh-grade Glioma, Medulloblastoma, and Ependymoma","Phase 1\u002F2 Trial of PEP-CMV + Nivolumab for Newly Diagnosed Diffuse Midline Glioma\u002FHigh-grade Glioma and Recurrent Diffuse Midline Glioma\u002FHigh-grade Glioma, Medulloblastoma, and Ependymoma (PRiME II)","PRiME II","Inclusion Criteria for All Patients:\n\n* Patients must be ≥4 and ≤25 years of age (inclusive) at the time of study enrollment\n* Metastatic Disease: Patients with M+ disease are eligible.\n* Adequate bone marrow function defined as:\n\n  * ANC (Absolute neutrophil count) ≥ 1000\u002Fµl.\n  * Platelets ≥ 75,000\u002Fµl.\n  * Hemoglobin \\> 8 g\u002FdL. (may be supported)\n* Adequate renal function defined as:\n\n  * Creatinine clearance or radioisotope GFR ≥ 70ml\u002Fmin\u002F1.73 m\\^2 OR A serum creatinine based on age\u002Fgender as listed in the protocol. Note: The threshold creatinine values in this table were derived from the Schwartz formula for estimating GFR utilizing child length and stature data published by the CDC.\n* Adequate liver function defined as:\n\n  * Total bilirubin ≤1.5 times institutional ULN\n  * AST(SGOT) ≤3 × institutional upper limit of normal\n  * ALT(SGPT) ≤3 × institutional upper limit of normal\n* The effects of PEP-CMV and nivolumab on the developing human fetus are unknown. For this reason, female participants of childbearing potential and male participants who are sexually active must agree to use adequate contraception prior to study entry, for the duration of study participation, and for at least 6 months after completion of study participation. Pregnancy tests must be obtained in girls and women who are post-menarchal at screening, at least 24 hours prior to the first dose of nivolumab and every 4 weeks (+\u002F- 1 week) regardless of dosing schedule. An extension up to 72 hours prior to the start of study treatment is permissible in situations where results cannot be obtained within the standard 24 hour window. Should a female participant become pregnant or suspect she is pregnant while participating in this study, or should a male participant suspect he has fathered a child, s\u002Fhe must inform the treating physician immediately.\n* Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants. All patients and\u002For their parents or legal guardians must sign an IRB approved written informed consent document.\n\nInclusion Criteria for Patients with Newly-Diagnosed High-Grade Gliomas (HGG) and Newly-Diagnosed (DMG) (Stratum I):\n\n* Stratum I patients must have histologically confirmed, newly-diagnosed HGG (such as anaplastic astrocytoma, glioblastoma) or newly-diagnosed DMG (such H3K27M mutant diffuse midline glioma).\n\n  * Patients with a newly-diagnosed HGG\u002FDMG must enroll within 6 weeks of their final dose of standard radiation therapy with or without chemotherapy.\n  * Patients with primary spinal cord tumors are eligible\n  * Patients with a radiographically typical diffuse intrinsic pontine glioma (DIPG), a subset of DMG, defined as a tumor with a pontine epicenter and diffuse involvement of more than 2\u002F3 of the pons, are eligible without histologic confirmation.\n  * Patients with brainstem lesions that do not meet these radiographic criteria will be eligible if there is histologic confirmation of an infiltrating astrocytoma WHO grades II-IV (excluding grade II BRAF altered gliomas).\n* Karnofsky \\>50 for patients \\> 16 years of age or Lansky \\>50 for patients \\\u003C16 years of age. Patients 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* Patients must have adequate neurologic function defined as:\n\n  * Patients with neurological deficits should have deficits that are stable for a minimum of 1 week prior to enrollment.\n* Patients must have received no prior therapy other than surgery, radiation, chemotherapy during radiotherapy and\u002For steroids (dexamethasone with goal to wean dexamethasone throughout protocol therapy), with the following qualifications:\n\n  * Patients with a newly diagnosed high-grade glioma or DMG must enroll within 42 days after their final dose of standard of care radiation therapy with or without chemotherapy.\n  * Patients with HGG or DMG are permitted, but not required, to have received chemotherapy during radiation. Bevacizumab is permitted prior to enrollment in patients with DMG or HGG. Patients must have received their last dose of bevacizumab at least 14 days prior to enrollment.\n  * For HGG patients, Patients must have received radiotherapy at a standard dose of \\~54 Gy in \\~1.8 Gy fractions for approximately 6 weeks with an acceptable variance of 10%. Radiation therapy must have begun no later than 30 days after the date of definitive surgery.\n  * For patients with DIPG, Patients must have received radiotherapy at a standard dose of radiotherapy of \\~54 Gy in \\~1.8 Gy daily fractions for approximately 6 weeks with an acceptable variance rate of 10%. Radiation therapy must have begun no later than 30 days after the date of radiographic diagnosis or biopsy.\n  * For patients with spinal cord HGG\u002FDMG: Patients must have received radiotherapy at a standard dose of \\~54 Gy in \\~1.8 Gy fractions for approximately 6-7 weeks with an acceptable variance rate of 10%.\n  * For patients with metastatic disease: Patients may have received standard dose craniospinal therapy.\n\nInclusion Criteria for patients with recurrent\u002Fprogressive HGG\u002FDMG (stratum II) or recurrent \u002Fprogressive MB or EPN (stratum III):\n\n* Recurrent MB, EPN, DMG or HGG: Patients must have a diagnosis of medulloblastoma that is recurrent, progressive or refractory. All patients must have histological verification of a MB, EPN, DMG or HGG at either original diagnosis or relapse.\n\n  * Patients must have adequate pretrial tumor material available (except DMG).\n  * Patients must have measurable disease defined as a lesion that can be measured in two perpendicular diameters on MRI.\n* Karnofsky ≥ 50% for patients \\>16 years of age or Lansky ≥ 50 for patients ≤ 16 years of age. Patients 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* Adequate neurologic function defined as:\n\n  * Patients with neurological deficits should have deficits that are stable for a minimum of 2 weeks prior to enrollment.\n  * Patients with current seizure disorders may be enrolled if seizures are well-controlled on antiepileptic therapies.\n* Previous enrollment and treatment on an interventional clinical trial(s) is allowed.\n* Patients must have received prior disease-directed therapy including radiotherapy for their initial diagnosis of MB, EPN, HGG, or DMG, unless the patient had a supratentorial EPN with GTR and radiation was not deemed necessary by the treating team.\n* Patients must have had their last fraction of:\n\n  * Craniospinal irradiation (if completed), total body irradiation or radiation to ≥ 50% of pelvis \\> 3 months prior to enrollment.\n  * Focal irradiation \\> 4 weeks prior to enrollment.\n* Patients must have received their last dose of myelosuppressive anticancer therapy at least 21 days prior to enrollment. Patients who have received nitrosoureas must have their last dose at least 42 days prior to enrollment.\n* Patients must have received their last dose of any immunotherapy agents at least 30 days prior to enrollment.\n* Patients must have received their last dose of non-myelosuppressive anticancer agents at least 7 days prior to study enrollment.\n* Patients must have received their last dose of any antibodies at least 21 days prior to enrollment.\n* Patients must have received their last dose of hematopoietic growth factors at least 14 days prior to enrollment for a long-acting growth factor (e.g. pegfilgrastim) or 7 days prior to enrollment for short-acting growth factor.\n* At least 90 days must have elapsed after an autologous stem cell infusion.\n\nExclusion Criteria - All Patients:\n\n* Pregnant or breast-feeding women will not be entered on this study due to known or unknown risks of fetal and teratogenic adverse events as seen in animal\u002Fhuman studies. Pregnancy tests must be obtained in girls and women who are post-menarchal at least 7 days prior to study enrollment. Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method.\n* Active infection requiring treatment.\n* Patients with malignancy related to HIV or solid organ transplant: known history of HIV, HBV surface antigen positivity or positive HCV antibody are not eligible. Viral testing is not required unless clinically indicated in patients without a known history\n* Known immunosuppressive disease.\n* Patients with active unrelated systemic illness including but not limited to renal, hepatic cardiac (congestive cardiac failure, myocardial infarction, myocarditis), or moderate to severe pulmonary problems generally defined by need for medical intervention (e.g., oxygen, medications) and\u002For limiting activities of daily living (generally CTCAE Grade 2 or higher) or shortness of breath with limited exertion are not eligible. Pulmonary conditions include (but are not limited to) COPD, asthma, and hemi-pneumectomy\n* Patients receiving concomitant immunosuppressive agents for medical conditions; inhaled corticosteroids for asthma are allowed.\n* Patients receiving concomitant tumor-directed therapy.\n* Patients receiving any other investigational drug therapy.\n* Previous enrollment and treatment on an interventional clinical trial (Stratum 1 only).\n* Patients on dexamethasone \\> 0.1 mg\u002FKg\u002Fday up to maximum dose of 4 mg\u002Fday or equivalent.\n* Patients with inability to return for follow-up visits or obtain follow-up studies required to assess toxicity to therapy.\n* Patients at high risk for imminent neurologic decline due to extensive bulk disease, midline shift, or herniation on MRI. These patients should be discussed with the Study Chair.","4 Years","25 Years",{"count":77,"type":21},68,[79,24],"PHASE1","This is a multisite, phase I\u002FII clinical trial in children and young adults with newly-diagnosed high-grade glioma (HGG), diffuse midline glioma (DMG) and recurrent HGG\u002FDMG, Medulloblastoma (MB), or ependymoma (EPN) to determine the safety, immunogenicity, and efficacy of a CMV-directed peptide vaccine plus checkpoint blockade.",[37,82,83,84],"Diffuse Midline High-grade Glioma","Medulloblastoma","Ependymoma",[86,87,47,88,28,89,90,91,92,93],"PEP-CMV","Peptide vaccine","Nivolumab","Vaccine therapy","Pp65","Recurrent","Newly diagnosed","Diffuse intrinsic pontine glioma","RECRUITING","2026-06-15",{"date":97,"type":58},"2026-06-17",{"date":99,"type":21},"2026-06-30",{"date":101,"type":21},"2051-06-30",{"name":103,"class":104},"Washington University School of Medicine","OTHER",3,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":113,"targetDuration":4,"studyType":22,"phases":115,"briefSummary":116,"conditions":117,"keywords":125,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":136},"100376708","phase-1-study-of-b7-h3-specific-car-t-cell-locoregional-immunotherapy-for-diffuse-intrinsic-pontine-gliomadiffuse-midline-glioma-and-recurrent-or-refractory-pediatric-central-nervous-system-tumors-100376708","NCT04185038","Study of B7-H3-Specific CAR T Cell Locoregional Immunotherapy for Diffuse Intrinsic Pontine Glioma\u002FDiffuse Midline Glioma and Recurrent or Refractory Pediatric Central Nervous System Tumors","Phase 1 Study of B7-H3-Specific CAR T Cell Locoregional Immunotherapy for Diffuse Intrinsic Pontine Glioma\u002FDiffuse Midline Glioma and Recurrent or Refractory Pediatric Central Nervous System Tumors","Inclusion Criteria:\n\n1. Age ≥ 1 and ≤ 26 years\n2. Diagnosis of refractory or recurrent CNS disease for which there is no standard therapy, or diagnosis of DIPG or DMG at any time point following completion of standard therapy\n3. Able to tolerate apheresis, or has apheresis product available for use in manufacturing\n4. CNS reservoir catheter, such as an Ommaya or Rickham catheter\n5. Life expectancy ≥ 8 weeks\n6. Lansky or Karnofsky score ≥ 60\n7. If patient does not have previously obtained apheresis product, patient must have discontinued, and recovered from acute toxic effects of, all prior chemotherapy, immunotherapy, and radiotherapy and discontinue the following prior to enrollment:\n\n   1. ≥ 7 days post last chemotherapy\u002Fbiologic therapy administration\n   2. 3 half lives or 30 days, whichever is shorter post last dose of anti-tumor antibody therapy\n   3. Must be at least 30 days from most recent cellular infusion\n   4. All systemically administered corticosteroid treatment therapy must be stable or decreasing within 1 week prior to enrollment with maximum dexamethasone dose of 2.5 mg\u002Fm2\u002Fday. Corticosteroid physiologic replacement therapy is allowed.\n8. Adequate organ function\n9. Adequate laboratory values\n10. Patients of childbearing\u002Ffathering potential must agree to use highly effective contraception\n\nExclusion Criteria:\n\n1. Presence of Grade ≥ 3 cardiac dysfunction or symptomatic arrhythmia requiring intervention\n2. Presence of primary immunodeficiency\u002Fbone marrow failure syndrome\n3. Presence of clinical and\u002For radiographic evidence of impending herniation\n4. Presence of \\>Grade 3 dysphagia\n5. Presence of active malignancy other than the primary CNS tumor under study\n6. Presence of active severe infection\n7. Receiving any anti-cancer agents or chemotherapy\n8. Pregnant or breastfeeding\n9. Subject and\u002For authorized legal representative unwilling or unable to provide consent\u002Fassent for participation in the 15 year follow up period\n10. Presence of any condition that, in the opinion of the investigator, would prohibit the patient from undergoing treatment under this protocol",{"count":114,"type":21},90,[79],"This is a Phase 1 study of central nervous system (CNS) locoregional adoptive therapy with autologous CD4+ and CD8+ T cells lentivirally transduced to express a B7H3-specific chimeric antigen receptor (CAR) and EGFRt. CAR T cells are delivered via an indwelling catheter into the tumor resection cavity or ventricular system in children and young adults with diffuse intrinsic pontine glioma (DIPG), diffuse midline glioma (DMG), and recurrent or refractory CNS tumors.\n\nA child or young adult meeting all eligibility criteria, including having a CNS catheter placed into the tumor resection cavity or into their ventricular system, and meeting none of the exclusion criteria, will have their T cells collected. The T cells will then be bioengineered into a second-generation CAR T cell that targets B7H3-expressing tumor cells. Patients will be assigned to one of 3 treatment arms based on location or type of their tumor. Patients with supratentorial tumors will be assigned to Arm A, and will receive their treatment into the tumor cavity. Patients with either infratentorial or metastatic\u002Fleptomeningeal tumors will be assigned to Arm B, and will have their treatment delivered into the ventricular system. The first 3 patients enrolled onto the study must be at least 15 years of age and assigned to Arm A or Arm B. Patients with DIPG will be assigned to Arm C and have their treatment delivered into the ventricular system. The patient's newly engineered T cells will be administered via the indwelling catheter for two courses. In the first course patients in Arms A and B will receive a weekly dose of CAR T cells for three weeks, followed by a week off, an examination period, and then another course of weekly doses for three weeks. Patients in Arm C will receive a dose of CAR T cells every other week for 3 weeks, followed by a week off, an examination period, and then dosing every other week for 3 weeks. Following the two courses, patients in all Arms will undergo a series of studies including MRI to evaluate the effect of the CAR T cells and may have the opportunity to continue receiving additional courses of CAR T cells if the patient has not had adverse effects and if more of their T cells are available.\n\nThe hypothesis is that an adequate amount of B7H3-specific CAR T cells can be manufactured to complete two courses of treatment with 3 or 2 doses given on a weekly schedule followed by one week off in each course. The other hypothesis is that B7H3-specific CAR T cells can safely be administered through an indwelling CNS catheter or delivered directly into the brain via indwelling catheter to allow the T cells to directly interact with the tumor cells for each patient enrolled on the study. Secondary aims of the study will include evaluating CAR T cell distribution with the cerebrospinal fluid (CSF), the extent to which CAR T cells egress or traffic into the peripheral circulation or blood stream, and, if tissues samples from multiple timepoints are available, also evaluate disease response to B7-H3 CAR T cell locoregional therapy.",[31,27,37,84,118,119,120,121,122,123,124],"Medulloblastoma, Childhood","Germ Cell Tumor","Atypical Teratoid\u002FRhabdoid Tumor","Primitive Neuroectodermal Tumor","Choroid Plexus Carcinoma","Pineoblastoma, Childhood","Glioma",[126],"CNS, CAR T cell, B7-H3, pediatric, young adult, brain tumor, DIPG, DMG","2026-04-07",{"date":129,"type":58},"2026-04-13",{"date":131,"type":58},"2019-12-11",{"date":133,"type":21},"2042-05",{"name":135,"class":104},"Seattle Children's Hospital",1,{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":143,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":16,"minAge":145,"maxAge":146,"enrollmentInfo":147,"targetDuration":4,"studyType":22,"phases":149,"briefSummary":150,"conditions":151,"keywords":155,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":4},"100618395","phase-1-gallium-maltolate-for-the-treatment-of-pediatric-patients-with-relapsed-or-refractory-pediatric-high-grade-glioma-and-atypical-teratoid-rhabdoid-tumor-100618395","NCT07331064","Gallium Maltolate for the Treatment of Pediatric Patients With Relapsed or Refractory Pediatric High-Grade Glioma and Atypical Teratoid Rhabdoid Tumor","A Phase 1 Clinical Trial of Gallium Maltolate for the Treatment of Pediatric Patients With Relapsed or Refractory Pediatric High-Grade Glioma and Atypical Teratoid Rhabdoid Tumor","GABRIEL","Inclusion Criteria:\n\n1. Voluntary written consent must be obtained before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.\n2. Patients must have a prior histological diagnosis of pediatric high-grade glioma (WHO Grade 3 or 4, including DMG\u002FDIPG) or ATRT (WHO Grade 4) or molecular features of such tumors (per the 6th volume of Central Nervous System Tumors in the 5th edition of the WHO Classification of Tumors).\n3. Patients are required to have received standard treatment for their tumor type which is considered to include at least:\n\n   a. pHGG (including DIPG\u002FDMG): maximum safe resection, focal radiotherapy. i. Addition of temozolomide, bevacizumab, or lomustine are considered of standard of care but not a requirement for inclusion.\n\n   ii. Addition of sites of radiotherapy to include all areas of disease as needed are considered standard of care but not a requirement for inclusion.\n\n   b. ATRT: maximum safe resection, radiotherapy (focal or craniospinal), and combination chemotherapy per a nationally-accepted ATRT regimen (such as DFCI-ATRT, COG ACNS0334, or MUV-ATRT).\n4. Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment; if after the required timeframe, the numerical eligibility criteria are met, e.g., blood count criteria, the patient is considered to have recovered adequately.\n\n   1. Cytotoxic chemotherapy (given systemically or intraventricular\u002Fintrathecal) or other anti-cancer agents known to be myelosuppressive ≥21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea).\n   2. Anti-cancer agents not known to be myelosuppressive (e.g., not associated with reduced platelet or absolute neutrophil count \\[ANC\\] counts): ≥7 days after the last dose of agent.\n   3. Antibodies: ≥ 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade ≤1 (for purposes of this study, bevacizumab is considered an antibody).\n   4. Corticosteroids:\n\n   i. If used to modify immune adverse events related to prior therapy, ≥14 days must have elapsed since last dose of corticosteroid.\n\n   ii. If used for symptom management related to tumor edema or elevated ICP, patient should be on a stable dose of corticosteroid for ≥7 days.\n\n   e. Hematopoietic growth factors: ≥14 days after the last dose of a long-acting growth factor (e.g., pegfilgrastim) or ≥ 7 days for short-acting growth factor.\n\n   f. Autologous stem cell infusion, including boost infusion: ≥42 days g. Cellular therapy: ≥42 days after the completion of any type of cellular therapy (e.g., modified T cells, natural killer \\[NK\\] cells, dendritic cells) h. h. Radiation therapy (XRT)\u002Fexternal beam irradiation including protons: ≥14 days after local XRT; ≥30 days after whole brain or craniospinal XRT.\n5. Patients must have measurable disease that can be assessed for response to treatment as defined by RAPNO for high-grade gliomas (59), RAPNO for DIPG (60), or RAPNO for medulloblastoma and other leptomeningeal seeding tumors (for ATRT) (61) that incorporates MRI assessment and clinical factors. In the absence of measurable disease, pathologic confirmation of recurrent disease is required (i.e., positive cerebrospinal fluid cytology).\n6. Male or female subjects must be 0-17 years of age.\n7. Lanksy\u002FKarnofsky performance status ≥50 (refer to Appendix 1). Subjects who are wheelchair-bound because of paralysis will be considered \"ambulatory\" when they are up in their wheelchair.\n8. Patients must have adequate bone marrow function as evidenced by:\n\n   1. An absolute neutrophil count (ANC) of \\>1,000\u002FµL (stable off any growth factor within one week of study drug administration.\n   2. Hemoglobin \\>8 g\u002FdL.\n   3. Platelet count \\>100,000\u002FµL without transfusion within one week.\n9. Patients must have adequate hepatic and renal function based on the following laboratory tests:\n\n   1. ALT ≤ 2 x ULN\n   2. AST ≤ 2 x ULN\n   3. Alkaline phosphatase ≤ 2 x ULN\n   4. Total bilirubin ≤ 2 x ULN\n   5. Adequate kidney function (as defined by eGFR \\>60 mL\u002Fmin\u002F1.72m2 as calculated by the Bedside Schwartz equation)\n10. Patients must be able to swallow liquid (suspension) medication, or have nasogastric or gastric tube present to give medication.\n11. Female subjects must meet one of the following:\n\n    1. Premenstrual OR\n    2. If subject is of childbearing potential, agree to practice two acceptable methods of contraception (combination methods require use of two of the following: diaphragm with spermicide, cervical cap with spermicide, contraceptive sponge, male or female condom, hormonal contraceptive) from the time of signing of the informed consent form through 21 days after the last dose of study agent, OR\n    3. Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \\[e.g., calendar, ovulation, symptothermal, postovulation methods\\] and withdrawal are not acceptable contraception methods.)\n12. Male subjects of child-fathering potential must agree to one of the following:\n\n    1. Practice effective barrier contraception during the entire study period and through 60 calendar days after the last dose of study agent, OR\n    2. Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence \\[e.g., calendar, ovulation, symptothermal, post-ovulation methods\\] and withdrawal are not acceptable methods of contraception.)\n13. Patients taking oral iron supplements or iron chelators must discontinue these medications at least one week prior to starting GaM since these agents may impact on the efficacy of GaM. Drug-drug interactions between GaM and other concomitant medications have not been reported.\n\nExclusion Criteria:\n\n1. Presence of other active malignant disease diagnosed within 12 months.\n2. Not appropriately recovered from prior therapy as defined by time frames listed in the inclusion criteria (Section 4.5.2.1).\n3. Known hypersensitivity to or intolerance to gallium-based medications.\n4. Concurrent use of cytotoxic chemotherapy is not permitted.\n5. Unstable or severe concurrent medical conditions such as severe heart disease, renal failure, uncontrolled diabetes mellitus, or severe lung disease.\n6. History of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis, or symptomatic pleural effusion.\n7. Patients who have not completed all standard-of-care treatments including surgical procedures and radiation therapy.\n8. Inability to tolerate an oral medication.\n9. Patients who are pregnant or nursing.\n10. Patients with any condition which, in the investigator's opinion, makes the patient unsuitable for study participation.","0 Months","17 Years",{"count":148,"type":21},15,[79],"In this study, we want to find out more about the side effects of an investigational drug for relapsed or refractory atypical teratoid rhabdoid tumor and high-grade glioma, Gallium Maltolate (GaM) and what doses of GaM are safe for people to take. Everyone in this study will receive GaM which is still experimental and is not approved by the U.S. Food and Drug Administration. We do not know all the ways that this drug may affect people. We hope the information from this study will help us develop a better treatment for relapsed or refractory atypical teratoid rhabdoid tumor and high-grade glioma in the future.",[152,153,37,28,154],"High Grade Gliomas","Atypical Teratoid Rhabdoid Tumors (ATRT)","Diffuse Intrinsic Pontine Gliomas (DIPG)",[28,156,157,38,158,159,160,161,162,163,164,165,166],"HGG","ATRT","relapse","refractory","progressive","high grade glioma","diffuse midline glioma","diffuse intrinsic pontine glioma","atypical teratoid rhabdoid tumor","brain tumor","pediatric","2025-12-29",{"date":169,"type":58},"2026-01-09",{"date":171,"type":21},"2026-05-15",{"date":173,"type":21},"2031-05-15",{"name":175,"class":104},"Sarah Rumler",{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":180,"acronym":4,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":182,"targetDuration":4,"studyType":184,"phases":4,"briefSummary":185,"conditions":186,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":136},"100293588","international-diffuse-intrinsic-pontine-glioma-dipgdiffuse-midline-glioma-dmg-registry-and-repository-100293588","NCT03101813","International Diffuse Intrinsic Pontine Glioma (DIPG)\u002FDiffuse Midline Glioma (DMG) Registry and Repository","Inclusion Criteria:\n\n* All patients of any age (living or deceased) with a diagnosis (either current or past) of a DIPG\u002FDMG tumor\n* Unless the patient is deceased, all patients and\u002For one parent or legal guardian must provide written informed consent as well as HIPAA\u002Frelease of information consent.",{"count":183,"type":21},1500,"OBSERVATIONAL","Doctors and other medical scientists want learn about the biology of DIPG\u002FDMG and to develop better ways to diagnose and treat patients with DIPG\u002FDMG. To do this, they need more information about the characteristics of DIPG\u002FDMG tumors. Therefore, they want to establish a central location for clinical information and tumor tissue collected from DIPG\u002FDMG patients.\n\nThe purposes of this study are:\n\n* To enroll patients diagnosed with DIPG\u002FDMG in the International DIPG\u002FDMG Registry and Repository.\n* To provide a central location for clinical information, scans, and tissue samples from patients with DIPG\u002FDMG enrolled in the registry.\n* To collect tissue samples in order to study how DIPG\u002FDMG works on the molecular level. Researchers may use the tissue samples to study molecules such as proteins and DNA. Proteins are needed for the body to function properly and DNA is the molecule that carries our genetic information. Other researchers will be able to use the stored samples in the future to learn more about DIPG\u002FDMG. The information researchers get from the research studies will be kept in the registry along with the clinical information.\n* To help investigators around the world to work together to make more consistent diagnosis and better design of future research studies. We hope this will lead to better treatments for DIPG\u002FDMG in the future.",[27,187,37],"Diffuse Midline Glioma, H3 K27M-Mutant","2025-10-16",{"date":190,"type":58},"2025-10-20",{"date":192,"type":58},"2012-06",{"date":194,"type":21},"2047-06",{"name":196,"class":104},"Children's Hospital Medical Center, Cincinnati",{"id":198,"slug":199,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":11,"sex":16,"minAge":204,"maxAge":205,"enrollmentInfo":206,"targetDuration":4,"studyType":22,"phases":208,"briefSummary":209,"conditions":210,"keywords":215,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":136},"100462233","phase-1-gd2-car-t-cells-for-pediatric-brain-tumours-100462233","NCT05298995","GD2-CAR T Cells for Pediatric Brain Tumours","Phase I Study of Anti-GD2 Chimeric Antigen Receptor-Expressing T Cells in Pediatric and Young Adult Patients Affected by Relapsed\u002FRefractory Central Nervous System Tumors","Inclusion Criteria:\n\n1. Imaging assessments performed within 14 days of start of treatment\n2. Age: 6months-30years\n3. Measurable or evaluable disease on at least 2 dimensions on MRI at the time of treatment enrollment\n4. Karnofsky\u002FLansky≥60\n5. Recoverfromthetoxiceffectsofpreviousradiationandchemotherapies:grade4and or 3 non-hematologic toxicities must have resolved to grade ≤ 2; in presence of chronic complications (i.e. treatment-associated thrombocytopenia), patient must be clinically stable, according to the opinion of the treating physicians, and meet all other eligibility criteria\n6. Positioning of an implantable intraventricular access device (CodmanHolterRickham reservoir, Integra LifeSciences, NJ, U.S.A) and a microdialysis probe (71 high cutoff microdialysis bolt catheter, M Dialysis AB, Stockholm Sweden)\n7. Written and signed informed consent from patients, parents or legal guardians. For subjects \\\u003C 18 year-old their legal guardian must give informed consent. In addition, pediatric subjects will be included in age-appropriate discussion and written informed assent will be obtained for those greater than or equal to 7 years of age, when appropriate\n8. Patients of childbearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study and for four months after receiving the preparative regimen\n9. Females of childbearing potential must have a negative pregnancy test because of the potentially dangerous effects on the fetus\n\nExclusion Criteria:\n\n1. Pregnant or lactating women\n2. Severe,uncontrolledactiveinfections\n3. HIV or active HCV and\u002For HBV infection\n4. Rapidly progressive disease with life expectancy \\\u003C 6 weeks\n5. Historyofgrade3or4hypersensitivitytomurineprotein-containingproducts\n6. Hepatic function: inadequate liver function defined as total bilirubin \\> 4x upper limit of normal (ULN) or transaminase (ALT and AST) \\> 6 x ULN based on age and laboratory specific normal ranges\n7. Renal function: serum creatinine \\> 3x ULN for age\n8. Blood oxygen saturation \\\u003C 90%\n9. Cardiac function: left ventricular ejection fraction lower than 45% by ECHO\n10. Marrow function: absolute neutrophils count (ANC) lower than 500\u002Fmm3 and\u002For platelets lower than 20.000 (not reached by transfusion)\n11. Congestive heart failure, cardiac arrhythmia, psychiatric illness, or social situations that would limit compliance with study requirements or in the opinion of the principal investigator (PI) would pose an unacceptable risk to the subject. 12.Concurrent or recent prior therapies, before infusion:\n\n    1. If receiving glucocorticoids, patient must be on a stable or weaning dose for at least 7 days prior to infusion. Recent or current use of inhaled\u002Ftopical\u002Fnon- absorbable steroids is not exclusionary. Subjects receiving steroid therapy at physiologic replacement doses only are allowed provided there has been no increase in dose for at least 2 weeks prior to starting apheresis\n    2. Systemic chemotherapy in the 3 weeks preceding infusion\n    3. Immunosuppressive agents less than or equal to 30 days\n    4. Radiation therapy must have been completed at least 6 weeks prior to enrollment\n    5. Otheranti-neoplasticinvestigationalagentscurrentlyorwithin30dayspriorto start of protocol therapy\n\n13.Patient-derived GD2-CART01 production failure: vitality \\\u003C80%, CD3+ cells \\\u003C80%, CD3+ CAR+ cells \\\u003C20%, CD3+ CAR+ antitumor activity \\\u003C60% in functional co-culture assay at an Effector: Target ratio 1:1, viable CAR+ cells upon AP1903 exposition \\>20%, RCR positivity, Vector Copy Number \\>10, non-sterility, endotoxin contamination (\\> 1 EU\u002Fml)","6 Months","30 Years",{"count":207,"type":21},54,[79],"The purpose of this study is to test the safety and efficacy of iC9-GD2-CAR T-cells, a third generation (4.1BB-CD28) CAR T cell treatment targeting GD2 in paediatric or young adult patients affected by relapsed\u002Frefractory malignant central nervous system (CNS) tumors. In order to improve the safety of the approach, the suicide gene inducible Caspase 9 (iC9) has been included.",[211,118,212,213,37,27,214],"Brain Tumor, Pediatric","Embryonal Tumor","High Grade Glioma","Brain Tumor Adult",[216,161,217,37,27,218,219,47,220,221],"Brain tumors","medulloblastoma","CAR T cell","GD2-antigen","Pediatric Central Nervous System tumours","Central nervous system tumour young adults","2025-02-03",{"date":224,"type":58},"2025-02-05",{"date":226,"type":58},"2023-11-09",{"date":228,"type":21},"2038-11",{"name":230,"class":104},"Bambino Gesù Hospital and Research Institute"]