RecruitingPhase 1NCT07247396

CEA CAR-T Therapy After Cytoreduction in Colorectal Cancer Patients With Peritoneal Metastases

A Clinical Trial to Evaluate the Safety and Efficacy of CEA-Directed CAR-T Cell Immunotherapy in Patients With Advanced Colorectal Cancer and Peritoneal Metastases Following Cytoreductive Surgery


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

12 participants

Start Date

Nov 3, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This single-arm, open-label, dose-escalation trial aims to evaluate the safety and efficacy of CEA-targeted CAR-T cells and to obtain their pharmacokinetic profile in patients with advanced colorectal cancer and peritoneal metastases after cytoreductive surgery; the recommended dose will then be derived from these data.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests CEA-targeted CAR-T cell therapy (immune cells engineered to target the CEA protein found on colorectal cancer cells) given after cytoreductive surgery (surgery to remove as much cancer as possible) in people with colorectal cancer that has spread to the lining of the abdomen (peritoneal metastases). **You may be eligible if...** - You are 18 to 75 years old with confirmed colorectal cancer that has spread to the peritoneum - Standard treatments (oxaliplatin, irinotecan, fluorouracil, etc.) have failed or you have no effective treatment options - You have already undergone or are planned for cytoreductive surgery for your peritoneal metastases - Your tumor cells express the CEA protein **You may NOT be eligible if...** - Your cancer has spread to other distant organs beyond the peritoneum (e.g., liver, lungs) without control - You have serious organ dysfunction - You have active infections or autoimmune conditions - You are pregnant or breastfeeding 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.

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Interventions

BIOLOGICALCEA-targeted CAR-T cells

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


Locations(1)

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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NCT07247396


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