Study on Using CAR-T Cells Targeting CSPG4 for Treating Relapsed or Hard-to-Treat Head and Neck Cancer

Sponsor: UNC Lineberger Comprehensive Cancer Center

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06096038

Provider View

This clinical trial is testing a new treatment using modified immune cells called CAR-T cells to target a specific protein in head and neck cancer that has returned or not responded to standard treatments. The study aims to find a safe dose that can be tolerated by patients.

Patient Parameters

Program Overview

The goal of this study is to test the safety and effectiveness of a new treatment using CAR-T cells, which are specially modified immune cells designed to target a protein called CSPG4 in head and neck cancer. This treatment is experimental and not yet approved by the FDA. The study will determine how much of the CAR-T cells can be safely given to patients without causing too many side effects. The study is divided into two parts: first, blood is collected to create the CAR-T cells, and then these cells are given to patients after they receive chemotherapy to prepare their bodies. The results will help decide the best dose for future studies and could benefit cancer patients in the future.

Eligibility Criteria

Inclusion Criteria

  • Must provide written consent and agree to share personal health information.
  • Must be 18 years or older.
  • Must have a Karnofsky performance score greater than 60%, indicating the ability to carry out most daily activities.
  • Must have a confirmed diagnosis of recurrent or metastatic squamous cell carcinoma of the head and neck, including cancers of the oral cavity, oropharynx, hypopharynx, and larynx.

Exclusion Criteria

  • History or current severe heart disease, such as heart failure, coronary artery disease, uncontrolled high blood pressure, irregular heartbeats, or a heart attack in the past 6 months.
  • History of stroke or mini-stroke (TIA) within the past 12 months.
  • History of severe allergic reactions to the chemotherapy drugs cyclophosphamide or fludarabine.

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