NCT06866873

CD-19 CAR-T Cell for Pediatric ALL or Lymphoma

Safety and Feasibility Study of CD19 Chimeric Antigen Receptor (CAR) T Cells in Children with Relapsed or Refractory CD19 Positive Acute Lymphoblastic Leukemia or Lymphoma

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Hong Kong Children's Hospital · Academic / Other
• Sex: All
• Age: 1 Year – 17 Years
• Healthy volunteers: Not accepted

Summary

This study seeks to examine the efficacy and safety of the administration of autologous T cells that have been modified through the introduction of a chimeric antigen receptor (CAR) targeting the B cell surface antigen CD19 following administration of chemotherapy lymphodepletion regimen in children with relapsed or refractory acute lymphoblastic leukemia (ALL) or lymphoma. The overall goal of this study is to validate the safety profile of administration CD19-CAR T cells and describe the response rate in children with relapsed/refractory ALL or lymphoma.

Conditions

• Lymphoma, B-Cell
• Acute Lymphoblastic Leukemia, Pediatric

Interventions

Type	Name	Description
BIOLOGICAL	CAR-T	CAR-T cell (CHXCART01) infusion intravenously once at a dose of 0.2-2 million cells/kg recipient body weight

Timeline

• Start date: 2024-05-01
• Primary completion: 2037-12-31
• Completion: 2037-12-31
• First posted: 2025-03-10
• Last updated: 2025-03-10

Locations

1 site across 1 country: Hong Kong