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Illuminate: A Clinical Study Evaluating CAR T Immune Cell Therapy (BCB-276) for Patients With Diffuse Intrinsic Pontine Glioma (DIPG).

RecruitingPhase 2Ages 1 Year - 26 YearsAllBrainChild Bio, Inc
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In plain words

What the trial is, and whether it could suit you

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. To 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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Participants must be aged 1 and โ‰ค 26 years and weigh โ‰ฅ10kg. * 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 โ‰ฅ 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/fathering 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/or authorized legal representative willing to provide consent/assent for study participation, including participation in the 15-year long term follow up period. Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: * 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.
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What it tests

  • BCB-276
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Where

6 sites
Children's Hospital Los Angeles
Los Angeles, United States
Children's Healthcare of Atlanta
Atlanta, United States
Lurie Children's Hospital
Chicago, United States
Nationwide Children's Hospital
Columbus, United States
Children's Hospital of Philadelphia
Philadelphia, United States
Seattle Children's Hospital
Seattle, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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