NCT05415475

Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced Malignant Solid Tumors

A Safety and Efficacy Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced Malignant Solid Tumors

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Chongqing Precision Biotech Co., Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial is an open-label, single-arm clinical study. The main purpose is to verify the safety and efficacy of CAR-T cell preparations in the treatment of CEA-positive advanced malignant tumors, and to obtain the recommended dose and infusion scheme of CAR-T cell preparations for the treatment of patients with CEA-positive advanced malignant tumors.

Detailed description

Carcinoembryonic antigen (CEA) is a classic tumor marker, which is positively expressed in a variety of digestive tract tumors. In normal tissue cells, only a small amount of CEA is expressed in the cell membrane of digestive tract cells. In the early clinical trials of CAR-T targeting CEA carried out by the technical partner, it was found that CAR-T cell preparations have a certain killing effect on CEA-positive tumor cells. At the same time, no serious CAR-T-related adverse events were found through dose-escalating infusion. In this study, through the optimization of the CAR structure and the improvement of the culture method, the killing ability and survival ability of the CAR-T cell preparation on tumor cells in vitro and in vivo were improved to further verify the safety and efficacy.

Conditions

• Colorectal Cancer
• Esophageal Cancer
• Stomach Cancer
• Pancreatic Cancer
• Metastatic Tumor
• Recurrent Cancer

Interventions

Type	Name	Description
BIOLOGICAL	CEA CAR-T cells	Administration method: intravenous infusion or intraperitoneal injection； Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion.

Timeline

• Start date: 2021-09-10
• Primary completion: 2024-09-15
• Completion: 2025-09-15
• First posted: 2022-06-13
• Last updated: 2024-01-05

Locations

1 site across 1 country: China