RecruitingPhase 1NCT06126406

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

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


Sponsor

Chongqing Precision Biotech Co., Ltd

Enrollment

60 participants

Start Date

Nov 6, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a open-label, dose-escalating + dose-expansion clinical study, aiming to evaluate the safety and efficacy of CEA-targeted CART cell preparations, and to reliminarily observe the study drug in CEA-positive advanced malignant tumors. The pharmacokinetic characteristics of CART 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 trial is testing a new CAR-T cell therapy that targets a protein called CEA, which is found on the surface of many solid tumors. It is being studied in patients with advanced colorectal, esophageal, gastric, or pancreatic cancer whose cancer tests positive for CEA. **You may be eligible if:** - You are 18 or older with advanced, recurrent, or metastatic colorectal, esophageal, gastric, or pancreatic cancer - Your tumor tests positive for CEA (at least 10% of cancer cells have CEA on their surface) - You have already tried at least two prior treatment regimens without success - You have at least one measurable tumor - You have good physical functioning (ECOG score 0–2) - Your blood counts, heart, liver, and kidney function meet the required levels **You may NOT be eligible if:** - Your cancer has spread to the brain or the lining of the brain - You have active autoimmune disease or require immunosuppressive therapy - You have an active, uncontrolled infection - You have active hepatitis B, hepatitis C, HIV, or syphilis - You are pregnant or breastfeeding - You have significant heart disease 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 ludarabine and Cyclophosphamide before cell infusion.

BIOLOGICALCEA-targeted CAR-T cells

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


Locations(1)

The First Affiliated Hospital of Wannan Medical College

Wuhu, Anhui, China

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NCT06126406


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