Phase 1 Trial of GPC2-Directed Chimeric Antigen Receptor Autologous T Cells (GPC2 CAR T) for Relapsed or Refractory Neuroblastoma
This is a first in human dose escalation trial to determine the safety of administering GPC2 CAR T cells in patients with advanced neuroblastoma.
• Signed Informed Consent Form
• ≥ 1 year of age
• Disease status
‣ Patients must have high-risk neuroblastoma according to Children's Oncology Group risk classification at the time of study enrollment.
⁃ Histologically confirmed diagnosis of neuroblastoma that is recurrent/relapsed/persistent according to International Neuroblastoma Response Criteria
⁃ Patients must have evaluable or measurable disease at enrollment
• Adequate organ function
• Adequate performance status defined as Lanksy or Karnofsky performance score ≥60.
• Subjects of reproductive potential must agree to use acceptable birth control methods.