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

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age1-26
SponsorBrainChild Bio, Inc

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • BCB-276

Treatment groups

75 Participants
are divided into 1 treatment group

Sponsors and collaborators