RecruitingPhase 1NCT07250386

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

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


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

48 participants

Start Date

Oct 13, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a type of immune cell therapy called CEA-targeted CAR-T cells in patients with advanced cancers (including lung and breast cancer) whose tumors express a protein called CEA (carcinoembryonic antigen). Patients' own immune cells are collected, engineered to recognize CEA, and then infused back to fight the cancer. **You may be eligible if...** - You are 18 or older - You have confirmed advanced, metastatic, or recurrent solid tumor (including non-small cell lung cancer or breast cancer) - Your tumor tests positive for CEA - Your cancer has progressed after at least two prior lines of standard treatment - You have at least one measurable tumor - Your general health (ECOG 0–2) and organ function meet study requirements - Your expected survival is at least 12 weeks **You may NOT be eligible if...** - You have active or uncontrolled cancer spread to the brain or spinal fluid - You have a serious heart condition (Class III–IV heart failure, recent heart attack) - You have an active autoimmune disease or are on long-term immune-suppressing medications - You have active HIV, hepatitis B or C, or syphilis - You are pregnant or breastfeeding - You received another clinical trial treatment within the past 4 weeks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALCEA-targeted CAR-T (Intravenous)

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

BIOLOGICALCEA-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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07250386


Related Trials