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

Conditions

• Adult Cancer Patients
• Brain Tumor
• Brainstem Glioma
• CNS Tumor
• CNS Tumor, Adult
• CNS Tumor, Childhood
• Central Nervous System Tumor
• DIPG
• DMG
• Diffuse Intrinsic Pontine Glioma
• Diffuse Midline Glioma
• Pediatric Cancer

Eligibility Criteria

Sex

ALL

Age

1 Year - 26 Years

Healthy Volunteers

Not accepted

Interventions

• BCB-276 — 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. All eligible participants will receive up to 15 intraventricular administrations of BCB-276 every 2 weeks for an approximate total duration of 30 weeks.

Study Details

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.

Key Dates

Start date

Jul 31, 2026

Status verified

Jun 2026

Primary completion

Oct 31, 2028

Completion

Jul 31, 2030

Study Design

Enrollment

75 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: BCB-276 CAR-T therapy for newly diagnosed DIPG patients post-radiation therapy
  Participants will receive up to 15 intraventricular administrations of BCB-276 delivered every 14 days (+/- 2 days) for an approximate total duration of 30 weeks.

Primary Outcome Measure

Overall Survival [ Time Frame: 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). ]

Central Contacts

• BrainChild Bio Study Team
  425-569-8747
  [email protected]

Locations (6)

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