Using modified T cells to treat relapsed head and neck cancer

Administration of T Cells Expressing Chondroitin-Sulfate-Proteoglycan-4 Specific Chimeric Antigen Receptors (CAR) in Subjects With Head and Neck Squamous Cell Carcinoma (HNSCC)

This study is testing a new treatment using modified immune cells to see if it can help people with relapsed head and neck cancer feel better and improve their outcomes.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 33 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: UNC Lineberger Comprehensive Cancer Center (other)
• Drugs / interventions: cyclophosphamide, fludarabine, chimeric antigen receptor, chemotherapy
• Locations: 1 site (Chapel Hill, North Carolina)
• Trial ID: NCT06096038 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the safety and tolerability of a new treatment involving autologous T lymphocyte chimeric antigen receptor cells targeting the CSPG4 antigen in patients with relapsed or refractory head and neck cancer. The trial consists of two parts: first, blood will be collected to prepare the modified T cells, and second, these cells will be infused into patients following lymphodepletion chemotherapy. The goal is to determine the maximum safe dose of the iC9.CAR-CSPG4 T cells and gather data that could benefit future cancer patients.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with recurrent or metastatic squamous cell carcinoma of the head and neck.

Not a fit: Patients with severe progressive heart disease or recent history of stroke may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat head and neck cancers.

How similar studies have performed: Other studies using CAR-T cell therapies have shown promising results, indicating potential for success with this novel approach.

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.

Where this trial is running

Chapel Hill, North Carolina

• Lineberger Comprehensive Cancer Center at University of North Carolina Chapel Hill — Chapel Hill, North Carolina, United States (RECRUITING)

Study contacts

• Principal investigator: Jared Weiss, MD — UNC Lineberger Comprehensive Cancer Center
• Study coordinator: Catherine Cheng

Conditions: Head and Neck Cancer, Relapse, Recurrent, Refractory Cancer, cellular therapy