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

NCT07680439 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: BCB276-PRT-0001
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 6

Brief Summary

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.

Conditions

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

Keywords

BCB-276; B7-H3-specific Chimeric Antigen Receptor [CAR] T cell therapy; B7-H3; B7-H3 CAR T; B7-H3 CAR T Cells; Chimeric antigen receptor T cells; CAR T Cell; Immunotherapy; Cell Therapy; Pediatric; Children; Adolescent; Young Adult; Adult

Outcome Measures

Primary Outcomes (1)

• Overall Survival

  Up to 24 months from date of enrollment

  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).

Secondary Outcomes (4)

• Safety and Tolerability of BCB-276

  Up to 35 weeks from enrollment (28 days after last dose of BCB-276).

• Radiographic Response to BCB-276

  Up to 24 months from date of enrollment.

• Presence of BCB-276 in Cerebrospinal Fluid (CSF)

  Up to approximately 30 weeks from first dose of BCB-276.

• Progression-Free Survival (PFS)

  Up to approximately 24 months from date of enrollment.

Study Arms (1)

BCB-276 CAR-T therapy for newly diagnosed DIPG patients post-radiation therapy

EXPERIMENTAL

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.

Biological: BCB-276

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.

BCB-276 CAR-T therapy for newly diagnosed DIPG patients post-radiation therapy

Eligibility Criteria

• Age: 1 Year - 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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.
• 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.

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.
• Presence of any condition that, in the Investigator's opinion, would prohibit the participant from undergoing treatment under this protocol.

Sponsors & Collaborators

• BrainChild Bio, Inc: lead

Study Sites (6)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Children's Healthcare of Atlanta

Atlanta, Georgia, 30329, United States

Location

Lurie Children's Hospital

Chicago, Illinois, 60611, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Diffuse Intrinsic Pontine Glioma; Brain Neoplasms; Central Nervous System Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Brain Stem Neoplasms; Infratentorial Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Cori Abikoff, MD

  BrainChild Bio, Inc

  STUDY DIRECTOR

Central Study Contacts

BrainChild Bio Study Team

CONTACT

425-569-8747; clinicaltrials@brainchildbio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-arm, externally controlled phase 2 clinical study. All eligible participants will receive BCB-276 by repeated intraventricular administrations for a planned course of up to 15 doses. The primary endpoint for the study is overall survival which will be compared to outcomes from a registry of similar individuals with DIPG treated with standard therapy. The starting point for outcome measurement will be aligned between study participants and registry patients. All enrolled participants will be considered evaluable for the primary endpoint regardless of whether they received BCB-276.

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: July 2, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): July 1, 2030
• Last Updated: July 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)