Illuminate: A Clinical Study Evaluating CAR T Immune Cell Therapy (BCB-276) for Patients With Diffuse Intrinsic Pontine Glioma (DIPG).
Eligible age
1–26 yrs
Accepts
All genders
Locations
6 states
Healthy volunteers
No
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About this study
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. BCB-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.
Sponsor: BrainChild Bio, Inc
You may qualify if…
- ✓ 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/fathering potential must agree to use highly effective contraception from the time of enrollment through 12 months following the last T cell infusion.
You may not qualify if…
- ✕ 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.
Where it's recruiting
Los Angeles
Atlanta
Chicago
Columbus
Philadelphia
Seattle
Source: ClinicalTrials.gov · NCT07680439 · last updated 2026-08-04