BCB-276 CAR T therapy for DIPG in children and young adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 trial evaluates BCB-276, a B7-H3-targeted CAR T cell therapy, in children and young adults with DIPG after radiotherapy. Participants undergo leukapheresis to collect immune cells, which are engineered to target B7-H3 and then delivered intraventricularly via a CNS reservoir. The treatment is given roughly every two weeks for up to 15 doses over about 7–8 months, with regular safety checks, MRIs, and labs. Outcomes include safety, tumor response, and survival compared with registry data from similar DIPG patients.

Why it matters

Who can join: the full rules

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.

Where it's running

• Children's Healthcare of Atlanta
  Atlanta, Georgia, United States Recruiting
• Children's Hospital of Philadelphia
  Philadelphia, Pennsylvania, United States Recruiting
• Seattle Children's Hospital
  Seattle, Washington, United States Recruiting
• Children's Hospital Los Angeles
  Los Angeles, California, United States Not yet recruiting
• Lurie Children's Hospital
  Chicago, Illinois, United States Not yet recruiting
• Nationwide Children's Hospital
  Columbus, Ohio, United States Not yet recruiting

Study contacts

• Study coordinator: BrainChild Bio Study Team
• Email: clinicaltrials@brainchildbio.com
• Phone: 425-569-8747

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.