[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07680439":3,"trial-entities:NCT07680439":219,"trial-summary:NCT07680439":223},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":31,"study_type":46,"primary_purpose":47,"phases":48,"enrollment_info":50,"interventions":53,"primary_outcomes":59,"secondary_outcomes":64,"sex":81,"minimum_age":82,"maximum_age":83,"healthy_volunteers":84,"eligibility_criteria":85,"std_ages":108,"locations":111,"central_contacts":208,"overall_officials":213,"references":217,"see_also_links":218},"NCT07680439","BCB276-PRT-0001","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","RECRUITING","2030-07","2026-07","2026-08-04","2026-08","BrainChild Bio, Inc","INDUSTRY",true,"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.","Diffuse intrinsic pontine glioma (DIPG) is a rare and aggressive brainstem tumor that primarily affects children and has limited treatment options. Radiation therapy is the current standard of care and may provide temporary benefit, but new treatment approaches are needed.\n\nThis Phase 2 study will evaluate BCB-276, an investigational B7-H3-targeted Chimeric Antigen Receptor (CAR) T cell therapy, in children and young adults with DIPG after completion of initial standard radiation therapy. The study will assess survival, safety, and tumor response. All eligible participants will receive BCB-276, and outcomes will be compared with information from similar individuals with DIPG whose data have been collected in a registry.\n\nTo take part in this study, eligible patients must begin participation within 6 weeks after completing radiation therapy and must not have received prior anti-cancer therapy other than radiation with or without temozolomide. Participation includes collection of participant's white blood cells by leukapheresis, manufacturing of BCB-276 from the participant's own immune cells, and placement of a catheter or reservoir to deliver treatment directly into the fluid-filled spaces of the brain.\n\nBCB-276 is given at participating research centers approximately every 2 weeks for a planned course of up to 15 doses over approximately 7-8 months. Study visits include treatment, safety monitoring, MRI scans, laboratory tests, and other assessments. Participants may be followed for up to approximately 2 years from the first BCB-276 treatment, and some follow-up visits may be conducted remotely. Because BCB-276 is investigational, side effects may occur and safety will be closely monitored.",[19,20,21,22,23,24,25,26,27,28,29,30],"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",[32,33,34,35,36,37,38,39,40,41,42,43,44,45],"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","INTERVENTIONAL","TREATMENT",[49],"PHASE2",{"count":51,"type":52},75,"ESTIMATED",[54],{"type":55,"name":32,"description":56,"armGroupLabels":57},"BIOLOGICAL","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.",[58],"BCB-276 CAR-T therapy for newly diagnosed DIPG patients post-radiation therapy",[60],{"measure":61,"description":62,"timeFrame":63},"Overall Survival","Up to 24 months from date of enrollment","Overall Survival (OS) as defined as time from the date of enrollment to death from any cause (up to 24 months from date of enrollment).",[65,69,73,77],{"measure":66,"description":67,"timeFrame":68},"Safety and Tolerability of BCB-276","Incidence of adverse events, including serious adverse events, and adverse events leading to discontinuation of study treatment.","Up to 35 weeks from enrollment (28 days after last dose of BCB-276).",{"measure":70,"description":71,"timeFrame":72},"Radiographic Response to BCB-276","Measure the frequency of disease response (progressive disease, stable disease, partial response, complete response) based on MRI assessment per RANO criteria.","Up to 24 months from date of enrollment.",{"measure":74,"description":75,"timeFrame":76},"Presence of BCB-276 in Cerebrospinal Fluid (CSF)","Quantify the presence and amount of BCB-276 in CSF.","Up to approximately 30 weeks from first dose of BCB-276.",{"measure":78,"description":79,"timeFrame":80},"Progression-Free Survival (PFS)","PFS as measured by time in months, from date of diagnosis to first incidence of clinical or radiographically confirmed progression.","Up to approximately 24 months from date of enrollment.","ALL","1 Year","26 Years",false,{"inclusion":86,"exclusion":98,"raw_text":107},[87,88,89,90,91,92,93,94,95,96,97],"Participants must be aged 1 and ≤ 26 years and weigh ≥10kg.","Diagnosis of Diffuse Intrinsic Pontine Glioma (DIPG) based on imaging, with or without biopsy confirmation consistent with high-grade glioma or diffuse midline glioma","Able to tolerate leukapheresis and other study procedures in the opinion of the Investigator.","Central Nervous System (CNS) reservoir catheter present prior to first dose of study drug.","Participant must have completed standard radiation therapy within 6 weeks of enrollment for participation.","Performance Status of ≥ 60; mild to moderate restriction or better. Lansky (under 16 years of age) or Karnofsky (16 years of age or older).","Adequate organ function and overall clinical status to participate, including stable or improving neurologic symptoms.","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.","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.","Participant must meet all other health and safety criteria defined in the study protocol.","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.",[99,100,101,102,103,104,105,106],"Previous tumor-directed therapy or treatment-directed clinical study other than standard radiation with or without temozolamide.","Evidence of metastatic disease.","Requirement of high or increasing doses of corticosteroids prior to participation.","Severe swallowing difficulties or other significant clinical conditions that may interfere with participation.","Presence of an active malignancy other than DIPG.","Active or uncontrolled human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection based on protocol-required laboratory testing.","Pregnant or breastfeeding.","Presence of any condition that, in the Investigator's opinion, would prohibit the participant from undergoing treatment under this protocol.","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.",[109,110],"CHILD","ADULT",[112,130,143,160,178,193],{"facility":113,"status":114,"city":115,"state":116,"zip":117,"country":118,"contacts":119,"geoPoint":127},"Children's Hospital Los Angeles","NOT_YET_RECRUITING","Los Angeles","California","90027","United States",[120,124],{"role":121,"phone":122,"email":123},"CONTACT","323-361-2121","neurooncresearch@chla.usc.edu",{"name":125,"role":126},"Tom Davidson, MD","PRINCIPAL_INVESTIGATOR",{"lat":128,"lon":129},34.05223,-118.24368,{"facility":131,"status":114,"city":132,"state":133,"zip":134,"country":118,"contacts":135,"geoPoint":140},"Children's Healthcare of Atlanta","Atlanta","Georgia","30329",[136,138],{"role":121,"email":137},"aflacdevtreferral@choa.org",{"name":139,"role":126},"Sheila McThenia, MD",{"lat":141,"lon":142},33.749,-84.38798,{"facility":144,"status":114,"city":145,"state":146,"zip":147,"country":118,"contacts":148,"geoPoint":157},"Lurie Children's Hospital","Chicago","Illinois","60611",[149,153,156],{"name":150,"role":121,"phone":151,"email":152},"Alicia Lenzen, MD","312-227-4090","alenzen@luriechildrens.org",{"name":154,"role":121,"email":155},"Arinchaya Limpanich, CRC","alimpanich@luriechildrens.org",{"name":150,"role":126},{"lat":158,"lon":159},41.85003,-87.65005,{"facility":161,"status":114,"city":162,"state":163,"zip":164,"country":118,"contacts":165,"geoPoint":175},"Nationwide Children's Hospital","Columbus","Ohio","43205",[166,170,174],{"name":167,"role":121,"phone":168,"email":169},"Ryuma Tanaka, MD","614-722-3250","Ryuma.Tanaka@nationwidechildrens.org",{"name":171,"role":121,"phone":172,"email":173},"Joanna Weinbrecht-Acree","614-355-1232","Joanna.Weinbrecht-Acree@nationwidechildrens.org",{"name":167,"role":126},{"lat":176,"lon":177},39.96118,-82.99879,{"facility":179,"status":114,"city":180,"state":181,"zip":182,"country":118,"contacts":183,"geoPoint":190},"Children's Hospital of Philadelphia","Philadelphia","Pennsylvania","19104",[184,188],{"name":185,"role":121,"phone":186,"email":187},"CART Nurse Navigator","445-942-5981","CARTNurseNavigator@chop.edu",{"name":189,"role":126},"Jessica Foster, MD",{"lat":191,"lon":192},39.95238,-75.16362,{"facility":194,"status":8,"city":195,"state":196,"zip":197,"country":118,"contacts":198,"geoPoint":205},"Seattle Children's Hospital","Seattle","Washington","98105",[199,203],{"name":200,"role":121,"phone":201,"email":202},"HemOnc Clinic","206-987-2106","HemOncCRAs@seattlechildrens.org",{"name":204,"role":126},"Sarah Leary, MD",{"lat":206,"lon":207},47.60621,-122.33207,[209],{"name":210,"role":121,"phone":211,"email":212},"BrainChild Bio Study Team","425-569-8747","clinicaltrials@brainchildbio.com",[214],{"name":215,"affiliation":13,"role":216},"Cori Abikoff, MD","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":220,"biomarkers":221},[19],[222],"CD276 wt Allele",{"nct_id":4,"found":15,"summary":224,"prompt_version":234},{"design":225,"status":226,"heading":227,"summary":228,"follow_up":229,"word_count":230,"commitments":231,"compensation":232,"drugs_mentioned":233},"This is an interventional study planning to enroll 75 participants. All eligible participants will receive BCB-276, and outcomes will be compared to information from similar individuals with DIPG whose data have been collected in a registry.","completed","Illuminate: CAR T-cell Therapy (BCB-276) for DIPG","This study, called Illuminate, is testing an investigational treatment called BCB-276 for children and young adults with Diffuse Intrinsic Pontine Glioma (DIPG), an aggressive brain tumor. BCB-276 is a CAR T-cell therapy, which means it uses your own immune cells that are specially trained to find and fight cancer. To join, you must be between 1 and 26 years old, have DIPG, and enroll within 6 weeks of finishing standard radiation therapy. The main goal is to see if BCB-276 can improve how long patients live (overall survival) after treatment. This study is currently recruiting 75 participants.","Overall survival will be measured for up to 24 months from the date of enrollment.",97,"You would undergo a procedure called leukapheresis to collect your white blood cells, have BCB-276 manufactured, and receive treatment directly into the fluid-filled spaces of your brain approximately every 2 weeks for up to 15 doses over about 7-8 months.","Not stated in the trial record.",[32],"v2"]