NCT07680439 Illuminate: A Clinical Study Evaluating CAR T Immune Cell Therapy (BCB-276) for Patients With Diffuse Intrinsic Pontine Glioma (DIPG).
| NCT ID | NCT07680439 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | BrainChild Bio, Inc |
| Condition | Diffuse Intrinsic Pontine Glioma |
| Study Type | INTERVENTIONAL |
| Enrollment | 75 participants |
| Start Date | 2026-09-04 |
| Primary Completion | 2028-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 75 participants in total. It began in 2026-09-04 with a primary completion date of 2028-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Cori Abikoff, MD
STUDY DIRECTOR
BrainChild Bio, Inc
Frequently Asked Questions
Who can join the NCT07680439 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 26 Years, studying Diffuse Intrinsic Pontine Glioma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07680439 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07680439 currently recruiting?
Yes, NCT07680439 is actively recruiting participants. Contact the research team at clinicaltrials@brainchildbio.com for enrollment information.
Where is the NCT07680439 trial being conducted?
This trial is being conducted at Los Angeles, United States, Atlanta, United States, Chicago, United States, Columbus, United States and 2 additional locations.
Who is sponsoring the NCT07680439 clinical trial?
NCT07680439 is sponsored by BrainChild Bio, Inc. The principal investigator is Cori Abikoff, MD at BrainChild Bio, Inc. The trial plans to enroll 75 participants.