Title: Phase I Trial: T4 Immunotherapy of Head and Neck Cancer1
Principal Investigators: John Maher, MD PhD, King’s College London
Description: For this single-arm, phase 1 study (ClinicalTrials.gov Identifier: NCT01818323), researchers are evaluating whether patients with squamous cell cancer of the head and neck will respond to autologous T4+ positive T cells administered directly into the disease site.
The T4+ T cells will express T1E28z, a chimeric antigen receptor (CAR).
To qualify patients must have locally advanced or recurrent/metastatic disease not suitable for further standard treatment.
The primary outcomes are dose-limiting toxicities and determination of an optimal dose for a phase 2 trial. Secondary outcomes include serum cytokine levels post-treatment, persistence of T4+ T cells at disease site, and preliminary assessment of drug efficacy.
For more study information, including inclusion and exclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT01818323.
Status: This study is open and recruiting participants as of May 9, 2017.
This study is sponsored by King’s College London in collaboration with Guy’s and St Thomas’ National Health Service (NHS) Trust.
- Clinicaltrials.gov. Phase I trial: T4 immunotherapy of head and neck cancer. NCT01818323. https://clinicaltrials.gov/ct2/show/NCT01818323. Accessed May 9, 2017.