Illuminate: Study on CAR T Cell Therapy (BCB-276) for Patients with Diffuse Intrinsic Pontine Glioma (DIPG)
Sponsor: BrainChild Bio, Inc
ClinicalTrials ID:NCT07680439
This clinical trial is testing a new treatment called BCB-276, which uses a patient's own modified immune cells to target and attack DIPG, a rare and aggressive brain tumor in children and young adults. The study aims to see if this treatment is safe and can help improve survival after standard radiation therapy.
Patient Parameters
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Program Overview
This study is exploring a new treatment called BCB-276 for children and young adults with a rare brain tumor known as diffuse intrinsic pontine glioma (DIPG). BCB-276 is a type of CAR T cell therapy, which involves using a patient's own immune cells that are modified in a lab to recognize and attack cancer cells. The goal is to find out if BCB-276 is safe and can help patients live longer after they have completed standard radiation therapy. Participants must be between 1 and 26 years old, have a DIPG diagnosis, and join the study within 6 weeks of finishing radiation therapy. The treatment involves placing a catheter to deliver BCB-276 into the fluid around the brain every 2 weeks for about 7-8 months. The study includes travel to a research center, various procedures, and follow-up visits for up to 2 years to monitor safety and effectiveness.
Description
Diffuse intrinsic pontine glioma (DIPG) is a rare and aggressive brain tumor that mainly affects children and has limited treatment options. Radiation therapy is currently the standard treatment, but new approaches are needed. This study is testing BCB-276, a new CAR T cell therapy that targets a protein called B7-H3 on cancer cells. The study will look at how safe BCB-276 is and whether it can help patients live longer. Participants will have their white blood cells collected and modified to create BCB-276, which is then delivered directly into the brain's fluid spaces through a catheter. The treatment is given every 2 weeks for up to 15 doses over 7-8 months. Participants will have regular check-ups, including MRI scans and lab tests, to monitor their health and the treatment's effects. The study will follow participants for up to 2 years, with some follow-up visits possibly done remotely. Since BCB-276 is experimental, side effects may occur, and safety will be closely watched.
Eligibility Criteria
Inclusion Criteria
- Be between 1 and 26 years old and weigh at least 10 kg.
- Have a diagnosis of DIPG based on imaging, with or without a biopsy confirming high-grade glioma or diffuse midline glioma.
- Be able to undergo leukapheresis and other study procedures.
- Have a CNS reservoir catheter in place before the first dose of the study drug.
- Have completed standard radiation therapy within 6 weeks of joining the study.
- Have a performance status score of 60 or higher, indicating mild to moderate restriction or better.
- Have adequate organ function and stable or improving neurological symptoms.
- Agree to use effective contraception from enrollment through 12 months after the last T cell infusion if of childbearing or fathering potential.
- Have a programmable ventriculoperitoneal (VP) shunt if applicable and be able to tolerate temporary adjustments for the study.
- Meet all other health and safety criteria in the study protocol.
- Provide consent/assent for study participation, including a 15-year long-term follow-up period.
Exclusion Criteria
- Have received any tumor-directed therapy other than standard radiation with or without temozolomide.
- Have evidence of cancer spread beyond the brain.
- Require high or increasing doses of corticosteroids before joining the study.
- Have severe swallowing difficulties or other significant health issues that may interfere with participation.
- Have another active cancer besides DIPG.
- Have active or uncontrolled HIV, hepatitis B, or hepatitis C infection.
- Be pregnant or breastfeeding.
- Have any condition that the study doctor believes would prevent safe participation in the study.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Children's Hospital Los Angeles | 90027 | Los Angeles | California |
| Children's Healthcare of Atlanta | 30329 | Atlanta | Georgia |
| Lurie Children's Hospital | 60611 | Chicago | Illinois |
| Nationwide Children's Hospital | 43205 | Columbus | Ohio |
| Children's Hospital of Philadelphia | 19104 | Philadelphia | Pennsylvania |
| Seattle Children's Hospital | 98105 | Seattle | Washington |
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