RecruitingNot ApplicableNCT07152210

Clinical Study on the Safety and Preliminary Efficacy of CDH17/GUCY2C CAR-T in the Treatment of Patients With Advanced Colorectal Cancer

Clinical Study Evaluating the Safety and Preliminary Efficacy of CDH17/GUCY2C CAR-T in the Treatment of Patients With Advanced Colorectal Cancer


Sponsor

Guangzhou Bio-gene Technology Co., Ltd

Enrollment

20 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study is a single-arm, single-center investigator-initiated trial (IIT) designed to evaluate the safety and preliminary efficacy of CDH17/GUCY2C CAR-T cell therapy in patients with advanced colorectal cancer, as well as to assess its pharmacodynamic (PD) and pharmacokinetic (PK) profiles.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of immunotherapy called CAR-T cell therapy — where a patient's own immune cells are engineered to attack cancer — in people with advanced colorectal cancer. The CAR-T cells are designed to target two proteins (CDH17 and GUCY2C) found on colorectal cancer cells. **You may be eligible if...** - You have advanced colorectal cancer that has not responded to standard treatments or where standard treatments are not suitable - Your tumor has been tested and shows the CDH17 or GUCY2C proteins (by IHC test within the last 2 years) - You have at least one measurable tumor outside the brain - You are reasonably functional (ECOG score 0–1) with an expected survival of at least 3 months - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - You have brain cancer spread - You have had another cancer in the past 5 years - You have serious heart, liver, kidney, or lung disease - You have an autoimmune or inflammatory condition - You are pregnant or breastfeeding - You have had an organ transplant - You have an active infection requiring IV antibiotics 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

BIOLOGICALCAR-T

Eligible subjects who successfully passed screening will receive CAR-T cell infusion on Day 0 after lymphodepleting preconditioning chemotherapy.


Locations(1)

Dongguan Taixin Hospital

Dongguan, Guangdong, China

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NCT07152210


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