RecruitingPhase 1NCT06043466

A Clinical Trial Targeting CEA Chimeric Antigen Receptor T (CAR-T) for CEA Positive Advanced Malignant Solid Tumors

Phase I Clinical Study of Chimeric Antigen Receptor T Cells (C-13-60) in the Treatment of Carcinoembryonic Antigen (CEA) Positive Advanced Malignant Solid Tumors


Sponsor

Chongqing Precision Biotech Co., Ltd

Enrollment

30 participants

Start Date

Aug 11, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a single-arm, open, dose-increasing phase I clinical study to explore the safety, tolerability and pharmacokinetic characteristics of the drug C-13-60 cells, and preliminarily observe the efficacy of the drug in CEA positive late malignant solid tumors, and explore the applicable dose regimen for phase II clinical trials.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a type of immune cell therapy called CAR-T cells that are engineered to target a protein called CEA, which is found on the surface of several types of advanced solid tumors. The goal is to see if this therapy is safe and effective for patients whose cancer has progressed. **You may be eligible if...** - You are 18 or older - You have advanced colorectal, esophageal, gastric, pancreatic, non-small cell lung, breast, or bile duct cancer confirmed by biopsy or pathology - Your tumor tests positive for the CEA protein - Prior standard treatments have not worked **You may NOT be eligible if...** - You have uncontrolled active infections or serious organ problems - You have brain metastases that are unstable or untreated - 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.


Locations(2)

The First Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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NCT06043466


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