RecruitingPhase 1Phase 2NCT06006390

CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced 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

Sep 7, 2023

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 CAR-T cell therapy — a form of immune cell therapy engineered to target a protein called CEA — in patients with advanced solid tumors such as colorectal, esophageal, gastric, or pancreatic cancer. **You may be eligible if:** - You are 18 or older - You have an advanced, metastatic, or recurrent solid tumor (mainly colorectal, esophageal, gastric, or pancreatic cancer) - Your tumor tests positive for the CEA protein and your blood CEA level is above 10 - You have already tried at least two prior treatment regimens and they have not worked - You are in reasonably good health (ECOG 0–2) and your organs are functioning adequately **You may NOT be eligible if:** - You have a serious mental disorder - Your heart ejection fraction is below 50% - Your kidney, liver, or blood counts do not meet the required levels - You have poor blood oxygen levels 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: intraperitoneal injection;Subjects will receive conditioning therapy by Fludarabine and Cyclophosphamide before cell infusion.


Locations(3)

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

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NCT06006390


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