NCT06006390

CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced 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: Recruiting
• 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
• Pancreas Cancer
• Lung Cancer
• Breast 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: 2023-09-07
• Primary completion: 2025-12-31
• Completion: 2026-08-31
• First posted: 2023-08-23
• Last updated: 2024-08-09

Locations

3 sites across 1 country: China