NCT06010862

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

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

• Status: Recruiting
• 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 is a phase I clinical study to evaluate the safety and tolerability of CAR-T in patients with CEA-positive advanced/metastatic 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 4 dose groups, adopting a dose-escalating 3+3 design, and plan to recruit about 12 subjects with CEA-positive advanced/metastatic solid tumors.Intraperitoneal injection group have 4 dose groups, adopting a dose-escalating 3+3 design, and plan to recruit about 12 subjects with CD70-positive advanced/metastatic solid tumors.

Conditions

• Gastric Cancer
• Colon Cancer
• Pancreas Cancer
• Esophagus Cancer
• Cholangiocarcinoma
• Lung Cancer
• Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	CEA CAR-T cells	After lymphodepletion with Fludarabine and Cyclophosphamide,CAR T cells were transfused intravenically
BIOLOGICAL	CEA CAR-T cells	After lymphodepletion with Fludarabine and Cyclophosphamide,CAR T cells were injected intraperitoneally

Timeline

• Start date: 2023-09-30
• Primary completion: 2025-12-31
• Completion: 2026-09-30
• First posted: 2023-08-25
• Last updated: 2023-11-08

Locations

1 site across 1 country: China