Using modified T cells to treat relapsed head and neck cancer
Official title: Administration of T Cells Expressing Chondroitin-Sulfate-Proteoglycan-4 Specific Chimeric Antigen Receptors (CAR) in Subjects With Head and Neck Squamous Cell Carcinoma (HNSCC)
Run by UNC Lineberger Comprehensive Cancer Center · NCT06096038 · Data updated 2026-11-12
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 | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 33 (estimated) |
| Sponsor | UNC Lineberger Comprehensive Cancer Center Academic / other |
| Drugs / interventions | cyclophosphamide, fludarabine, chimeric antigen receptor, chemotherapy |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Status | Recruiting |
| Started | April 5, 2024 |
| Main results expected | December 30, 2028 |
| Study ends | November 30, 2030 |
| Registry record updated | November 5, 2026 |
| Trial ID | NCT06096038 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with recurrent or metastatic squamous cell carcinoma of the head and neck.
✕Probably not a fit
Patients with severe progressive heart disease or recent history of stroke may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Other studies using CAR-T cell therapies have shown promising results, indicating potential for success with this novel approach.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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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
- Email: UNCImmunotherapy@med.unc.edu
- Phone: +1 919-445-4208
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.