NCT07179692

CEA-Targeted CAR-T Therapy in CEA-Positive Advanced Solid Tumors

Clinical Study of CEA-Targeted Chimeric Antigen Receptor T Lymphocytes (CAR-T) in Advanced CEA-Positive Malignant Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Chongqing Precision Biotech Co., Ltd · Industry
• 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 three parallel subgroups: intravenous infusion, intrapleural infusion, and intraperitoneal 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

• Lung Cancer
• Gastric Cancer
• Colon Cancer
• Rectal Cancer
• Esophageal Cancer
• Pancreas Cancer

Interventions

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

Timeline

• Start date: 2025-09-12
• Primary completion: 2028-03-31
• Completion: 2028-05-31
• First posted: 2025-09-18
• Last updated: 2025-10-02

Locations

1 site across 1 country: China