NCT07504445

Clinical Study on the Efficacy and Safety of CAR-DC in the Treatment of Advanced Solid Tumors

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Peking University Shenzhen Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, open label, single arm clinical trial to evaluate the safety and the preliminary efficacy of chimeric antigen receptor-dendritic cell (CAR-DC) in the treatment of advanced solid tumors positive for one of the following antigens: ephrin type-A receptor 2 (EphA2), claudin-18 isoform 2 (CLDN18.2) , trophoblast cell surface antigen 2 (Trop2), human epidermal growth factor receptor 2 (HER2), guanylyl cyclase-C (GCC), glypican-3 (GPC3) and carcinoembryonic antigen (CEA).

Detailed description

Dendritic cell (DC) plays a vital role in T cell priming and anti-tumor immune activation. A novel kind of engineered DC, chimeric antigen receptor-dendritic cell (CAR-DC) can reverse the immune suppression in tumor-microenvironment (TME) to enhance anti-tumor therapy. This is a prospective, open label, single arm clinical trial to evaluate the safety and the preliminary efficacy of CAR-DC in the treatment of advanced solid tumors positive for one of the following antigens: ephrin type-A receptor 2 (EphA2), claudin-18 isoform 2 (CLDN18.2) , trophoblast cell surface antigen 2 (Trop2), human epidermal growth factor receptor 2 (HER2), guanylyl cyclase-C (GCC) , glypican-3 (GPC3) AND carcinoembryonic antigen (CEA). A total number of 10 patients will receive two rounds of intravenous infusions of 30 million CAR-DC at an interval of 14 days and receive follow-up visits after the second round of infusion up to 1 or 2 years.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
BIOLOGICAL	CAR-DC treatment	The patients will receive intravenous injection (iv) of 30 million CAR-DC for two rounds at an interval of 14 days.

Timeline

• Start date: 2026-04-03
• Primary completion: 2028-04-03
• Completion: 2028-04-03
• First posted: 2026-03-31
• Last updated: 2026-03-31

Locations

1 site across 1 country: China