[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100645242":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":31,"responsibleParty":139,"collaborators":20,"id":141,"slug":20,"hasResults":142,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":20,"eligibilityCriteria":146,"healthyVolunteers":142,"sex":147,"minAge":148,"maxAge":149,"enrollmentInfo":150,"targetDuration":20,"studyType":153,"phases":154,"briefSummary":156,"conditions":157,"keywords":170,"overallStatus":184,"whyStopped":20,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":194},{"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",[32,51,66,85,105,122],{"facility":33,"status":20,"city":34,"state":35,"zip":36,"country":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Children's Hospital Los Angeles","Los Angeles","California","90027","United States",{"type":39,"coordinates":40},"Point",[41,42],-118.24368,34.05223,{"lat":42,"lon":41},[45,48],{"name":20,"role":28,"phone":46,"phoneExt":20,"email":47},"323-361-2121","neurooncresearch@chla.usc.edu",{"name":49,"role":50,"phone":20,"phoneExt":20,"email":20},"Tom Davidson, MD","PRINCIPAL_INVESTIGATOR",{"facility":52,"status":20,"city":53,"state":54,"zip":55,"country":37,"cosmosGeoPoint":56,"geoPoint":60,"contacts":61},"Children's Healthcare of Atlanta","Atlanta","Georgia","30329",{"type":39,"coordinates":57},[58,59],-84.38798,33.749,{"lat":59,"lon":58},[62,64],{"name":20,"role":28,"phone":20,"phoneExt":20,"email":63},"aflacdevtreferral@choa.org",{"name":65,"role":50,"phone":20,"phoneExt":20,"email":20},"Sheila McThenia, MD",{"facility":67,"status":20,"city":68,"state":69,"zip":70,"country":37,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Lurie Children's Hospital","Chicago","Illinois","60611",{"type":39,"coordinates":72},[73,74],-87.65005,41.85003,{"lat":74,"lon":73},[77,81,84],{"name":78,"role":28,"phone":79,"phoneExt":20,"email":80},"Alicia Lenzen, MD","312-227-4090","alenzen@luriechildrens.org",{"name":82,"role":28,"phone":20,"phoneExt":20,"email":83},"Arinchaya Limpanich, CRC","alimpanich@luriechildrens.org",{"name":78,"role":50,"phone":20,"phoneExt":20,"email":20},{"facility":86,"status":20,"city":87,"state":88,"zip":89,"country":37,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"Nationwide Children's Hospital","Columbus","Ohio","43205",{"type":39,"coordinates":91},[92,93],-82.99879,39.96118,{"lat":93,"lon":92},[96,100,104],{"name":97,"role":28,"phone":98,"phoneExt":20,"email":99},"Ryuma Tanaka, MD","614-722-3250","Ryuma.Tanaka@nationwidechildrens.org",{"name":101,"role":28,"phone":102,"phoneExt":20,"email":103},"Joanna Weinbrecht-Acree","614-355-1232","Joanna.Weinbrecht-Acree@nationwidechildrens.org",{"name":97,"role":50,"phone":20,"phoneExt":20,"email":20},{"facility":106,"status":20,"city":107,"state":108,"zip":109,"country":37,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Children's Hospital of Philadelphia","Philadelphia","Pennsylvania","19104",{"type":39,"coordinates":111},[112,113],-75.16362,39.95238,{"lat":113,"lon":112},[116,120],{"name":117,"role":28,"phone":118,"phoneExt":20,"email":119},"CART Nurse Navigator","445-942-5981","CARTNurseNavigator@chop.edu",{"name":121,"role":50,"phone":20,"phoneExt":20,"email":20},"Jessica Foster, MD",{"facility":123,"status":20,"city":124,"state":125,"zip":126,"country":37,"cosmosGeoPoint":127,"geoPoint":131,"contacts":132},"Seattle Children's Hospital","Seattle","Washington","98105",{"type":39,"coordinates":128},[129,130],-122.33207,47.60621,{"lat":130,"lon":129},[133,137],{"name":134,"role":28,"phone":135,"phoneExt":20,"email":136},"HemOnc Clinic","206-987-2106","HemOncCRAs@seattlechildrens.org",{"name":138,"role":50,"phone":20,"phoneExt":20,"email":20},"Sarah Leary, MD",{"type":140,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","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":151,"type":152},75,"ESTIMATED","INTERVENTIONAL",[155],"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.",[158,159,160,161,162,163,164,165,166,167,168,169],"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",[17,171,172,173,174,175,176,177,178,179,180,181,182,183],"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":187,"type":188},"2026-07-02","ACTUAL",{"date":190,"type":152},"2026-07",{"date":192,"type":152},"2030-07",{"name":5,"class":6},6]