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RECRUITING
NCT07250386
PHASE1

A Study of CEA-Targeted CAR-T Therapy in Patients With CEA-Positive Advanced Solid Tumors

Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

View on ClinicalTrials.gov

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.

Official title: A Clinical Study to Evaluate the Safety and Efficacy of CEA-Targeted Chimeric Antigen Receptor T (CAR-T) Cells in Patients With CEA-Positive Advanced Malignant Solid Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2025-10-13

Completion Date

2028-09-30

Last Updated

2025-11-26

Healthy Volunteers

No

Interventions

BIOLOGICAL

CEA-targeted CAR-T (Intravenous)

Administration method: intravenous infusion. Subjects will receive conditioning therapy by Fludarabine and Cyclophosphamide before cell infusion

BIOLOGICAL

CEA-targeted CAR-T (Intrapleural)

Administration method: intrapleural infusion. Subjects will receive conditioning therapy by Fludarabine and Cyclophosphamide before cell infusion

Locations (1)

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China