By Tim Cortese – CancerNetwork –
The FDA has granted regenerative medicine advance therapy (RMAT) designation to BCB-276, an investigational B7-H3 autologous chimeric antigen receptor (CAR) T-cell therapy, for the treatment of diffuse intrinsic pontine glioma (DIPG), an incurable pediatric brain tumor, according to a press release from the developer, BrainChild Bio, Inc.1 The company also announced that they are advancing BCB-276 toward a biologics license application submission via a single, pivotal phase 2 trial planned for the fourth quarter of 2025.
The BCB-276 approach of locoregionally delivering targeted CAR T cells directly into the cerebrospinal fluid using an indwelling reservoir-catheter device was successfully implemented and tested in the phase 1 BrainChild-03 trial (NCT04185038). Results from arm C of the trial were recently published in Nature Medicine
