RecruitingPhase 1NCT06010862

Clinical Study of CEA-targeted CAR-T Therapy for CEA-positive Advanced/Metastatic Malignant Solid Tumors

A Safety and Efficacy Clinical Study of CEA-targeted CAR-T Therapy forCEA-positive Advanced/Metastatic Malignant Solid Tumors


Sponsor

Chongqing Precision Biotech Co., Ltd

Enrollment

36 participants

Start Date

Sep 30, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a phase I clinical study to evaluate the safety and tolerability of CAR-T in patients with CEA-positive advanced/metastatic solid tumors, and to obtain the maximum tolerated dose of CAR-T and phase II Recommended dose.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a CAR-T cell therapy that targets a protein called CEA (found on the surface of some cancer cells) for people with advanced digestive system cancers, particularly colorectal, stomach, esophageal, and pancreatic cancer. CAR-T is a cutting-edge treatment where a patient's own immune cells are engineered to attack cancer. **You may be eligible if...** - You are 18 or older - You have confirmed advanced, metastatic, or recurrent colorectal, esophageal, stomach, or pancreatic cancer - Your tumor tests positive for CEA protein (on at least 10% of cells) - You have already failed at least two lines of standard treatment - You are in reasonably good health (ECOG 0–2) - Your heart, kidney, liver, and blood counts are within acceptable ranges **You may NOT be eligible if...** - Your tumor does not express CEA - You have had only one prior line of treatment - You have serious mental illness - Your blood oxygen level is below 95% without extra oxygen - 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 CAR-T cells

After lymphodepletion with Fludarabine and Cyclophosphamide,CAR T cells were transfused intravenically

BIOLOGICALCEA CAR-T cells

After lymphodepletion with Fludarabine and Cyclophosphamide,CAR T cells were injected intraperitoneally


Locations(1)

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

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NCT06010862


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