NCT05538195

Safety and Efficacy of CEA-targeted CAR-T for CEA-positive Advanced Malignant Solid Tumors

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (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, it is divided into two subgroups: intravenous infusion and local infusion through the peritoneal cavity. Each subgroup includes a dose exploration stage (Part A) and a dose expansion stage (Part B). 3 patients were explored, starting from the low-dose group, and in the dose expansion phase, the safety and efficacy were further verified according to the safe recommended dose obtained in the dose exploration phase.

Conditions

• Gastric Cancer
• Colon Cancer
• Rectal Cancer
• Esophageal Cancer
• Pancreatic 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: intraperitoneal injection；Subjects will receive conditioning therapy by Fludarabine and Cyclophosphamide before cell infusion.

Timeline

• Start date: 2022-06-07
• Primary completion: 2024-12-30
• Completion: 2025-06-07
• First posted: 2022-09-13
• Last updated: 2022-09-13

Locations

1 site across 1 country: China