RecruitingPhase 1NCT07179692

CEA-Targeted CAR-T Therapy in CEA-Positive Advanced Solid Tumors

Clinical Study of CEA-Targeted Chimeric Antigen Receptor T Lymphocytes (CAR-T) in Advanced CEA-Positive Malignant Solid Tumors


Sponsor

Chongqing Precision Biotech Co., Ltd

Enrollment

108 participants

Start Date

Sep 12, 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 is testing a new type of immune cell therapy called CAR-T, which uses your own immune cells that are re-engineered to target a protein called CEA found on certain cancer cells. It is aimed at people with advanced solid tumors such as colorectal, stomach, esophageal, pancreatic, lung, or bile duct cancer that have not responded to standard treatments. **You may be eligible if...** - You are 18 or older - You have been diagnosed with advanced or metastatic cancer of the colon, stomach, esophagus, pancreas, lungs, or bile ducts - Your cancer has not responded to at least two prior lines of treatment - Your tumor tests positive for the CEA protein - You have at least one measurable area of cancer on imaging **You may NOT be eligible if...** - Your cancer does not test positive for CEA - You have active brain metastases or serious infections - You have severe heart, liver, or kidney problems - 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: intravenous infusion. Subjects will receive conditioning therapy by Fludarabine and Cyclophosphamide before cell infusion.

BIOLOGICALCEA-targeted CAR-T cells

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

BIOLOGICALCEA-targeted CAR-T cells

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


Locations(1)

The 901 Hospital of Joint Logistics Support Force of People Liberation Army

Hefei, Anhui, China

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NCT07179692


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