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

June 25, 2026 updated by: BrainChild Bio, Inc

A Phase 2 Pivotal Study of BCB-276, a B7-H3-Specific CAR T Cell Locoregional Immunotherapy for Diffuse Intrinsic Pontine Glioma

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90027
        • Children's Hospital Los Angeles
        • Principal Investigator:
          • Tom Davidson, MD
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30329
    • Illinois
    • Ohio
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia
        • Contact:
        • Principal Investigator:
          • Jessica Foster, MD
    • Washington
      • Seattle, Washington, United States, 98105
        • Seattle Children's Hospital
        • Principal Investigator:
          • Sarah Leary, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Biological: BCB-276

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Tolerability of BCB-276
Time Frame: Up to 35 weeks from enrollment (28 days after last dose of BCB-276).
Incidence of adverse events, including serious adverse events, and adverse events leading to discontinuation of study treatment.
Up to 35 weeks from enrollment (28 days after last dose of BCB-276).
Radiographic Response to BCB-276
Time Frame: Up to 24 months from date of enrollment.
Measure the frequency of disease response (progressive disease, stable disease, partial response, complete response) based on MRI assessment per RANO criteria.
Up to 24 months from date of enrollment.
Presence of BCB-276 in Cerebrospinal Fluid (CSF)
Time Frame: Up to approximately 30 weeks from first dose of BCB-276.
Quantify the presence and amount of BCB-276 in CSF.
Up to approximately 30 weeks from first dose of BCB-276.
Progression-Free Survival (PFS)
Time Frame: Up to approximately 24 months from date of enrollment.
PFS as measured by time in months, from date of diagnosis to first incidence of clinical or radiographically confirmed progression.
Up to approximately 24 months from date of enrollment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

BrainChild Bio, Inc

Investigators

  • Study Director: Cori Abikoff, MD, BrainChild Bio, Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

July 1, 2030

Study Registration Dates

First Submitted

June 22, 2026

First Submitted That Met QC Criteria

June 25, 2026

First Posted (Actual)

July 2, 2026

Study Record Updates

Last Update Posted (Actual)

July 2, 2026

Last Update Submitted That Met QC Criteria

June 25, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BCB276-PRT-0001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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