RecruitingNot ApplicableNCT06658951

Anti-HER2 CAR-T Cell Injection in Patients With HER2-positive Advanced Malignant Solid Tumors

Exploratory Study to Evaluate the Safety and Preliminary Efficacy of Anti-HER2 CAR-T Cell Injection in Patients With HER2-positive Advanced Malignant Solid Tumors


Sponsor

UTC Therapeutics Inc.

Enrollment

30 participants

Start Date

Apr 3, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a single-arm, open-label, exploratory clinical study to evaluate the safety and preliminary efficacy of Anti-HER2 CAR-T cell injection in patients with HER2-positive advanced malignant solid tumors.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study tests a type of immune cell therapy called CAR-T cells, which are the patient's own immune cells engineered to target a protein called HER2 found on many solid tumors. The treatment is for people whose cancer has not responded to standard therapies. **You may be eligible if...** - You are between 18 and 70 years old with a HER2-positive solid tumor (such as stomach, ovarian, breast, bladder, colon, lung, or other cancer) - Your cancer has stopped responding to standard treatment - You have at least one measurable tumor on imaging - You are generally well enough to carry out daily activities - Your life expectancy is at least 3 months **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have active hepatitis B infection - You have certain serious infections or immune conditions - You have untreated 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.

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Interventions

BIOLOGICALAnti-HER2 CAR-T cells

All eligible participants will receive a conditioning chemotherapy regimen of fludarabine, cyclophosphamide and ABRAXANE followed by Anti-HER2 CAR-T cell injection.


Locations(1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

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NCT06658951