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Phase 1 Study of B7-H3-Specific CAR T Cell Locoregional Immunotherapy for Diffuse Intrinsic Pontine Glioma/Diffuse Midline Glioma and Recurrent or Refractory Pediatric Central Nervous System Tumors

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Trial Profile

Phase 1 Study of B7-H3-Specific CAR T Cell Locoregional Immunotherapy for Diffuse Intrinsic Pontine Glioma/Diffuse Midline Glioma and Recurrent or Refractory Pediatric Central Nervous System Tumors

Status: Recruiting
Phase of Trial: Phase I

Latest Information Update: 27 Apr 2025

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At a glance

  • Drugs BCB 276 (Primary)
  • Indications CNS cancer
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Acronyms BrainChild03

Most Recent Events

  • 22 Apr 2025 According to BrainChild Bio media release, company announced that the investigational B7-H3 targeting autologous CAR T-cell therapy has been granted Breakthrough Therapy designation (BTD) by the U.S Food and Drug Administration (FDA) for the treatment of diffuse intrinsic pontine glioma (DIPG). This FDA designation was based on the promising overall survival benefit in patients with brain tumors treated with an autologous B7-H3 CAR T-cell therapy observed in the BrainChild-03 Phase 1 trial.
  • 07 Jan 2025 Preliminary safety and efficacy results presented in the BrainChild Bio Media Release.
  • 07 Jan 2025 According to BrainChild Bio media release, company plans to advance BCB-276 in a single pivotal registration trial designed to accelerate the path to submit a Biologics License Application for the treatment of children and young adults with DIPG. This clinical plan is based on alignment with the FDA at a Type B meeting. This potentially accelerated clinical path for BCB-276 is supported by the preliminary data for BCB-276 from this Phase 1 clinical trial conducted by Seattle Children.

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