NCT06972576

Clinical Study of Combined EphA2-targeted CAR-DC and CAR-T Cell Therapy for Non-small Cell Lung Cancer

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, single-arm clinical study designed to evaluate the safety and preliminary efficacy of EphA2-targeted CAR-DC combined with CAR-T cell therapy in patients with non-small cell lung cancer.

Detailed description

Main purpose: To evaluate the safety of EphA2-targeted CAR-T cells in combination with CAR-DCs in patients with advanced non-small cell lung cancer during the dose-escalation phase. To determine the maximum tolerated dose of EphA2-targeted CAR-DCs when administered in combination with CAR-T cells. Secondary purpose: To assess the overall response rate (ORR), including complete response (CR) and partial response (PR), as well as overall survival (OS) and disease-free survival (DFS) in patients receiving the combination therapy. To evaluate the in vivo persistence, immunophenotype, and functional activity of CAR-T cells and CAR-DCs following infusion.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	EphA2-targeted CAR-T Cells	Autologous T cells genetically modified to express a chimeric antigen receptor (CAR) targeting EphA2
BIOLOGICAL	EphA2-targeted CAR-DCs	Autologous dendritic cells (DCs) genetically modified to express a chimeric antigen receptor (CAR) targeting EphA2

Timeline

• Start date: 2025-05-09
• Primary completion: 2026-04-01
• Completion: 2027-04-01
• First posted: 2025-05-15
• Last updated: 2025-05-15

Locations

1 site across 1 country: China