NCT06948994

A Clinical Trial on Autologous NK Cells Combined With GD2 Monoclonal Antibody in the Treatment of Children With Newly Diagnosed High-risk or Relapsed/Refractory Neuroblastoma

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Guangzhou Women and Children's Medical Center · Academic / Other
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, single-arm, open, single-center clinical trial to evaluate the safety and efficacy of autologous NK cells combined with chemotherapy and GD2 monoclonal antibody in the treatment of newly diagnosed high-risk or relapsed/refractory neuroblastoma in children. Fifteen eligible subjects are planned to be included. The objective is to evaluate the safety and efficacy of autologous NK cells combined with GD2 monoclonal antibody in the treatment of children with newly diagnosed high-risk or relapsed/refractory neuroblastoma, which is expected to be safe and effective in improving PFS and DCR in children with refractory/recurrent neuroblastoma.

Conditions

• Neuroblastoma
• GD2 Antibody
• Autologous NK Cell

Interventions

Type	Name	Description
COMBINATION_PRODUCT	autologous NK cell plus GD2 antibody	Combination of autologous NK cells and GD2 monoclonal antibody

Timeline

• Start date: 2025-05-01
• Primary completion: 2027-04-30
• Completion: 2028-04-30
• First posted: 2025-04-29
• Last updated: 2025-04-29