Study Details

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Administration of T Cells Expressing CAR in Subjects with Head and Neck Squamous Cell Carcinoma

You have been asked to take part in this study because you have a type of cancer called Squamous Cell Carcinoma of the Head and Neck. This type of cancer usually starts in the squamous cells that line the moist surfaces inside the nose, mouth and throat. You have already received treatment for this cancer, however, the cancer came back or did not get better. This gene therapy study will use your own immune cells as treatment for your cancer. This treatment is experimental. It has not been approved by the Food and Drug Administration for treatment of your type of cancer. This study is done to investigate the safety, possible harms and side effects of administering modified immune cells in treating squamous cell carcinoma of the head and neck.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)

Location

North Carolina (Statewide)

What will be asked of you

The study involves blood draws, blood test,biopsies,procedures,imaging/scanning and follow -up visits. You will donate your blood so the study team can modify your cells to make the study treatment cells. The study treatment cells may be able to target cancerous cells better than the body's normal cells. The study team will do blood tests and other procedures to see if you are eligible to get the treatment cells. If you are eligible, you will complete three days of treatment that will prepare your body to accept the study treatment cells better. You will then return to the clinic for one day of study cell treatment. After treatment, you will have clinic visits for checkup tests and assessment including lab tests and imaging of your tumor. You will continue follow up visits based on how well you have responded to the study treatment. This study requires 3 mandatory biopsies, which will be obtained specifically for the purpose of this study. A biopsy is taking a sample of your tumor tissue. All biopsies are mandatory if accessible.

Incentives

In-person visits:
Minimum of 14 through first year of participation; likely more depending on side effects

Phone or online visits:
Visits all in person unless disease has worsened, then can be contacted by phone during follow up

Total length of participation:
Total participation up to 15 years total

Looking for Specific Volunteers

Able to participate:

Patient with diagnosis of sqauamous cell carcinoma with CNS involvement.
Patient with relapsed or refractory disease after at least 1/2 prior line of therapies.
Measurable disease within 90 days prior to cell collection and again within 7 days prior to chemotherapy.

Not eligible if:

Patients taking corticosteroids at doses of 10 mg or more of prednisone
Patients with HIV, HTLV, Hepatitis B or Hepatitis C infections
History of intolerance to fludarabine

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Lineberger clinical Research
cancerclinicaltrials@med.unc.edu
(919) 966-4432

Primary Visit Location

UNC Hospitals / UNC Medical Center
101 Manning Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Jared Weiss
LCCC - Clinical Trials

Study Type

Clinical or Medical
Interventional

Study Topics

Cancer (Head and Neck)

IRB Number

21-1294