Autologous CAR-T Cells Targeting CSPG4 in Relapsed/Refractory HNSCC

Launched by UNC LINEBERGER COMPREHENSIVE CANCER CENTER · Oct 18, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment for patients with head and neck cancer that has returned after standard treatments. The study focuses on using modified immune cells, called iC9.CAR-CSPG4 T cells, which are designed to target cancer cells more effectively. The main goal is to determine how safe this treatment is and to find out the highest dose that patients can tolerate without experiencing serious side effects. This research is important because it could lead to better treatment options for cancer patients in the future.

To participate in the trial, individuals must be at least 18 years old and have a confirmed diagnosis of recurrent or metastatic squamous cell carcinoma of the head and neck. Participants will receive a type of chemotherapy to prepare their bodies before being infused with the modified T cells. Throughout the study, doctors will monitor participants closely to assess their response to the treatment and any side effects. It's essential for potential participants to review the inclusion and exclusion criteria carefully, especially if they have certain medical conditions that might affect their eligibility.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Unless otherwise noted, subjects must meet all of the following criteria to participate in all phases of the study:
• • 1. Written informed consent and HIPAA authorization for release of personal health information explained to, understood by and signed by the subject; subject given a copy of the informed consent form.
• • 2. Age ≥ 18 years at the time of consent.
• • 3. Karnofsky score of \> 60%
• • 4. Histologically or cytologically confirmed stage recurrent/metastatic squamous cell carcinoma of the head and neck as defined by American Joint Committee on Cancer (AJCC). This includes squamous cancer of: oral cavity, oropharynx, hypopharynx and larynx.
• Exclusion Criteria:
• • 1. Subject with a history or current severe progressive heart disease (congestive heart failure, coronary artery disease, uncontrolled arterial hypertension, uncontrolled arrhythmia, or myocardial infarction in the past 6 months.
• • 2. Subject with a history of stroke or transient ischemic attack (TIA) within 12 months before procurement.
• • 3. Subject with a history of severe immediate hypersensitivity reaction to cyclophosphamide or fludarabine.