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Phase I Trial: T4 Immunotherapy of Head and Neck Cancer

Head and Neck Cancer Clinical Trial

Official title:
Phase I Trial: T4 Immunotherapy of Head and Neck Cancer

Clinical Trial Summary

The overall goal of this study is to investigate the safety of T4 immunotherapy when administered to treat loco-regional disease in Squamous Cell Cancer of the Head and Neck (SCCHN) that is not suitable for conventional active therapy. The investigators propose to conduct an open-labelled, non-randomized, dose-escalation phase I trial in which autologous T4+ T-cells are administered to patients with SCCHN. T-cells will be engineered to express a second generation chimeric antigen receptor (CAR) named T1E28z. Engineered T-cells will be injected directly into the tumour site. Patients will not be lymphodepleted. A classical 3+3 design will be employed, with dose escalation from 10^7 through to 10^9 transduced T4+ T-cells, dependent upon toxicity monitoring. It is anticipated that up to 30 patients will be enrolled over the course of the study.

Clinical Trial Description

Further information is provided in van Schalkwyk MC, Papa SE, Jeannon JP, Guerrero Urbano T, Spicer JF, Maher J. Design of a phase I clinical trial to evaluate intratumoral delivery of ErbB-targeted chimeric antigen receptor T-cells in locally advanced or recurrent head and neck cancer. Hum Gene Ther Clin Dev. 2013 Sep;24(3):134-42. doi: 10.1089/humc.2013.144. PubMed ID: 24099518 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01818323
Study type Interventional
Source King's College London
Contact John Maher, MD PhD
Phone (+44) 02071881468
Email john.maher@kcl.ac.uk
Status Recruiting
Phase Phase 1
Start date June 2015
Completion date December 2023
View Details
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