NCT05396300

A Clinical Study of CEA-targeted CAR-T in the Treatment of CEA-positive Advanced Malignant Solid Tumors

A Phase I Clinical Study of Anti-CEA CAR-T Therapy in the Treatment of CEA-positive Advanced Malignant Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Weijia Fang, MD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I clinical study to evaluate the safety and tolerability of CAR-T in patients with CEA-positive advanced malignant solid tumors, and to obtain the maximum tolerated dose of CAR-T and phase II Recommended dose.

Detailed description

This is a single-center, double-arm, open-label study. The study plans to set up 2 groups,Intravenous infusion group have 3 dose groups, adopting a dose-escalating 3+3 design, and plan to recruit about 9-18 subjects with CEA-positive advanced malignant solid tumors.Intraperitoneal injection group have 4 dose groups, adopting a dose-escalating 3+3 design, and plan to recruit about 12-24 subjects with CEA-positive advanced malignant solid tumors.

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: 2022-05-25
• Primary completion: 2024-06-30
• Completion: 2024-06-30
• First posted: 2022-05-31
• Last updated: 2025-04-22

Locations

1 site across 1 country: China