NCT07680439RecruitingPhase 2
Illuminate: A Clinical Study Evaluating CAR T Immune Cell Therapy (BCB-276) for Patients With Diffuse Intrinsic Pontine Glioma (DIPG).
A Phase 2 Pivotal Study of BCB-276, a B7-H3-Specific CAR T Cell Locoregional Immunotherapy for Diffuse Intrinsic Pontine Glioma
Source: ClinicalTrials.gov · Last updated 28 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 75 (estimated)
- First submitted
- 22 Jun 2026
- Start date
- 4 Sept 2026
- Primary completion date
- Oct 2028
- Lead sponsor
- BrainChild Bio, Inc
- Diseases
- Childhood cancers
- NCT number
- NCT07680439
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 75
- From 4 Sept 2026 to the primary completion date, Oct 2028
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous tumor-directed therapy or treatment-directed clinical study other than standard radiation with or without temozolamide.
- Requirement of high or increasing doses of corticosteroids prior to participation.
Other illness
- Evidence of metastatic disease.
- Severe swallowing difficulties or other significant clinical conditions that may interfere with participation.
- Presence of an active malignancy other than DIPG.
- Presence of any condition that, in the Investigator's opinion, would prohibit the participant from undergoing treatment under this protocol.
Lab values
- Active or uncontrolled human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection based on protocol-required laboratory testing.
Other
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Pregnant or breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 1 year to 26 years · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children's Healthcare of Atlanta Coordinator of this site? Confirm its status | Atlanta | United States | Recruiting |
| Lurie Children's Hospital Coordinator of this site? Confirm its status | Chicago | United States | Not yet recruiting |
| Nationwide Children's Hospital Coordinator of this site? Confirm its status | Columbus | United States | Not yet recruiting |
| Children's Hospital Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Not yet recruiting |
| Children's Hospital of Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
| Seattle Children's Hospital Coordinator of this site? Confirm its status | Seattle | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.