[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645242":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":31,"responsibleParty":140,"collaborators":20,"id":142,"slug":143,"hasResults":144,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":20,"eligibilityCriteria":148,"healthyVolunteers":144,"sex":149,"minAge":150,"maxAge":151,"enrollmentInfo":152,"targetDuration":20,"studyType":155,"phases":156,"briefSummary":158,"conditions":159,"keywords":172,"overallStatus":186,"whyStopped":20,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":196},{"fullName":5,"class":6},"BrainChild Bio, Inc","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"BCB-276 CAR-T therapy for newly diagnosed DIPG patients post-radiation therapy","EXPERIMENTAL","Participants will receive up to 15 intraventricular administrations of BCB-276 delivered every 14 days (+\u002F- 2 days) for an approximate total duration of 30 weeks.",[13],"Biological: BCB-276",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","BCB-276","Following completion of standard radiation therapy, eligible participants with DIPG will undergo leukapheresis, a procedure to collect white blood cells used to manufacture BCB-276, an autologous CAR T cell therapy made from the participant's own immune cells designed to target B7-H3.\n\nAll eligible participants will receive up to 15 intraventricular administrations of BCB-276 every 2 weeks for an approximate total duration of 30 weeks.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Cori Abikoff, MD","STUDY_DIRECTOR",[26],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"BrainChild Bio Study Team","CONTACT","425-569-8747","clinicaltrials@brainchildbio.com",[32,52,67,86,106,123],{"facility":33,"status":20,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Children's Hospital Los Angeles","Los Angeles","California","90027","United States","US",{"type":40,"coordinates":41},"Point",[42,43],-118.24368,34.05223,{"lat":43,"lon":42},[46,49],{"name":20,"role":28,"phone":47,"phoneExt":20,"email":48},"323-361-2121","neurooncresearch@chla.usc.edu",{"name":50,"role":51,"phone":20,"phoneExt":20,"email":20},"Tom Davidson, MD","PRINCIPAL_INVESTIGATOR",{"facility":53,"status":20,"city":54,"state":55,"zip":56,"country":37,"countryCode":38,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"Children's Healthcare of Atlanta","Atlanta","Georgia","30329",{"type":40,"coordinates":58},[59,60],-84.38798,33.749,{"lat":60,"lon":59},[63,65],{"name":20,"role":28,"phone":20,"phoneExt":20,"email":64},"aflacdevtreferral@choa.org",{"name":66,"role":51,"phone":20,"phoneExt":20,"email":20},"Sheila McThenia, MD",{"facility":68,"status":20,"city":69,"state":70,"zip":71,"country":37,"countryCode":38,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"Lurie Children's Hospital","Chicago","Illinois","60611",{"type":40,"coordinates":73},[74,75],-87.65005,41.85003,{"lat":75,"lon":74},[78,82,85],{"name":79,"role":28,"phone":80,"phoneExt":20,"email":81},"Alicia Lenzen, MD","312-227-4090","alenzen@luriechildrens.org",{"name":83,"role":28,"phone":20,"phoneExt":20,"email":84},"Arinchaya Limpanich, CRC","alimpanich@luriechildrens.org",{"name":79,"role":51,"phone":20,"phoneExt":20,"email":20},{"facility":87,"status":20,"city":88,"state":89,"zip":90,"country":37,"countryCode":38,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Nationwide Children's Hospital","Columbus","Ohio","43205",{"type":40,"coordinates":92},[93,94],-82.99879,39.96118,{"lat":94,"lon":93},[97,101,105],{"name":98,"role":28,"phone":99,"phoneExt":20,"email":100},"Ryuma Tanaka, MD","614-722-3250","Ryuma.Tanaka@nationwidechildrens.org",{"name":102,"role":28,"phone":103,"phoneExt":20,"email":104},"Joanna Weinbrecht-Acree","614-355-1232","Joanna.Weinbrecht-Acree@nationwidechildrens.org",{"name":98,"role":51,"phone":20,"phoneExt":20,"email":20},{"facility":107,"status":20,"city":108,"state":109,"zip":110,"country":37,"countryCode":38,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Children's Hospital of Philadelphia","Philadelphia","Pennsylvania","19104",{"type":40,"coordinates":112},[113,114],-75.16362,39.95238,{"lat":114,"lon":113},[117,121],{"name":118,"role":28,"phone":119,"phoneExt":20,"email":120},"CART Nurse Navigator","445-942-5981","CARTNurseNavigator@chop.edu",{"name":122,"role":51,"phone":20,"phoneExt":20,"email":20},"Jessica Foster, MD",{"facility":124,"status":20,"city":125,"state":126,"zip":127,"country":37,"countryCode":38,"cosmosGeoPoint":128,"geoPoint":132,"contacts":133},"Seattle Children's Hospital","Seattle","Washington","98105",{"type":40,"coordinates":129},[130,131],-122.33207,47.60621,{"lat":131,"lon":130},[134,138],{"name":135,"role":28,"phone":136,"phoneExt":20,"email":137},"HemOnc Clinic","206-987-2106","HemOncCRAs@seattlechildrens.org",{"name":139,"role":51,"phone":20,"phoneExt":20,"email":20},"Sarah Leary, MD",{"type":141,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","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":153,"type":154},75,"ESTIMATED","INTERVENTIONAL",[157],"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.",[160,161,162,163,164,165,166,167,168,169,170,171],"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",[17,173,174,175,176,177,178,179,180,181,182,183,184,185],"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":189,"type":190},"2026-07-02","ACTUAL",{"date":192,"type":154},"2026-07",{"date":194,"type":154},"2030-07",{"name":5,"class":6},6]