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

Overview

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.

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. This 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. To 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. BCB-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.