RecruitingPhase 1NCT06946615

Exploratory Clinical Study of Claudin18.2-Targeted CAR-DC and CAR-T Therapy in Advanced Colorectal Cancer

Exploratory Clinical Study of Combined Claudin18.2-Targeted CAR-DC and CAR-T Therapy in Patients With Advanced Colorectal Cancer


Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

18 participants

Start Date

Apr 8, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is an open-label, single-arm clinical study designed to evaluate the safety and preliminary efficacy of Claudin18.2-targeted CAR-DC combined with CAR-T cell therapy in patients with advanced colorectal cancer.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an experimental combination of two immune cell therapies — CAR-DC (dendritic cell) and CAR-T cell therapy — both engineered to target a protein called Claudin18.2 found on certain cancer cells, in people with advanced colorectal cancer that has stopped responding to standard treatments. **You may be eligible if...** - You have been diagnosed with advanced colon or rectal cancer confirmed by biopsy, with at least one measurable tumor on imaging - Your tumor tests positive for the Claudin18.2 protein - You have already received standard chemotherapy regimens (fluoropyrimidine, irinotecan, and oxaliplatin) and your cancer has progressed - You are in reasonably good physical condition **You may NOT be eligible if...** - Your tumor does not express Claudin18.2 - You have not yet tried standard chemotherapy options - Your organs are not functioning well enough for this therapy - You have active infections, uncontrolled autoimmune diseases, or brain metastases 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALClaudin18.2-targeted CAR-T Cells

Autologous T cells genetically modified to express a chimeric antigen receptor (CAR) targeting Claudin18.2.

BIOLOGICALClaudin18.2-targeted CAR-DCs

Autologous dendritic cells (DCs) genetically modified to express a chimeric antigen receptor (CAR) targeting Claudin18.2.


Locations(1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06946615


Related Trials