NCT07250386

A Study of CEA-Targeted CAR-T Therapy in Patients With CEA-Positive Advanced Solid Tumors

A Clinical Study to Evaluate the Safety and Efficacy of CEA-Targeted Chimeric Antigen Receptor T (CAR-T) Cells in Patients With CEA-Positive Advanced Malignant Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a single-arm, open-label, dose-escalating + dose-expansion clinical study, aiming to evaluate the safety and efficacy of CEA-targeted CAR-T cell preparations, and to preliminarily observe the study drug in CEA-positive advanced malignant tumors. The pharmacokinetic characteristics of CAR-T cell preparations for the treatment of patients with CEA-positive advanced malignancies were obtained and the recommended dose and infusion schedule.

Detailed description

According to the different infusion methods, patients will be assigned to two parallel subgroups: intravenous infusion, intrapleural infusion. Within each subgroup, the study is conducted in two sequential parts: 1. .Part A (dose-escalation): escalation begins at the lowest dose level; 3-6 subjects are enrolled at each dose level; 2. .Part B (dose-expansion): additional subjects are treated at the recommended dose identified in Part A to further evaluate safety and preliminary efficacy.

Conditions

• NSCLC (Advanced Non-small Cell Lung Cancer)
• Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	CEA-targeted CAR-T (Intravenous)	Administration method: intravenous infusion. Subjects will receive conditioning therapy by Fludarabine and Cyclophosphamide before cell infusion
BIOLOGICAL	CEA-targeted CAR-T (Intrapleural)	Administration method: intrapleural infusion. Subjects will receive conditioning therapy by Fludarabine and Cyclophosphamide before cell infusion

Timeline

• Start date: 2025-10-13
• Primary completion: 2028-06-30
• Completion: 2028-09-30
• First posted: 2025-11-26
• Last updated: 2025-11-26

Locations

1 site across 1 country: China