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

  • PhasePhase 2
  • StatusRecruiting
  • Planned enrollment75 people
  • Recruiting US sites3
  • SponsorBrainChild Bio, Inc
  • RegistryNCT07680439

Recruitment re-checked on ClinicalTrials.gov Oct 30, 2026. Public record; not medical advice.

Illuminate: A Clinical Study Evaluating CAR T Immune Cell Therapy (BCB-276) for Patients With Diffuse Intrinsic Pontine Glioma (DIPG).: a one-minute explainerNCT076804391 min

Eligibility

Who can join

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

  • Age1 Year to 26 Years
  • SexAll
  • Healthy volunteersNo

You may be able to join 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 cannot join 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.

The treatment

How it is intended to work

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

Treatments listed in the registry

  • 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.

The study

Treatment groups

Na · Single Group · masking: None

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.

What it involves

Procedures

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

  • MRI: Part of the study plan
  • radiation: Part of the study plan
  • leukapheresis: Part of the study plan

Goals

What the study measures

Main goals

  • Overall Survival (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).)

Other goals

  • Safety and Tolerability of BCB-276
  • Radiographic Response to BCB-276
  • Presence of BCB-276 in Cerebrospinal Fluid (CSF)
  • Progression-Free Survival (PFS)

Planned enrollment: 75 (estimated).

Where

Recruiting US sites

  • Children's Healthcare of Atlanta, Atlanta, Georgia
  • Children's Hospital of Philadelphia, Philadelphia, Pennsylvania
  • Seattle Children's Hospital, Seattle, Washington

Site status as of Oct 30, 2026. Check the live record before contacting a site.

Sources

Where this comes from

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Oct 27, 2026. Public record; not medical advice.

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