Phase I Trial: T4 Immunotherapy of Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT01818323|
Recruitment Status : Recruiting
First Posted : March 26, 2013
Last Update Posted : August 18, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Other: Intra-tumoral T4 immunotherapy||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Open label|
|Official Title:||Phase I Trial: T4 Immunotherapy of Head and Neck Cancer|
|Study Start Date :||June 2015|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||December 2019|
|Experimental: Intra-tumoral T4 immunotherapy||
Other: Intra-tumoral T4 immunotherapy
Intra-tumoral administration of T4-positive patient-derived T-cells contained within 1 mL.
Other Name: 4ab T1E28z positive T-cells
- Dose limiting toxicities for T4 immunotherapy in SCCHN and determine a safe and feasible recommended dose for phase II testing of intra-tumoral T4 immunotherapy. [ Time Frame: Up to 6 weeks post T4 administration ]Patients will be monitored intensely for the first 24 hours post T4 administration. Patients will the be assessed for signs of toxicity on days 3-4, 5-7, 8, 15, 29 and 43.
- To investigate serum cytokine levels after administration of T4 immunotherapy [ Time Frame: up to 6 weeks post T4 administration ]
- To investigate persistence of T4+ T-cells at the site of administration and in the peripheral circulation [ Time Frame: up to 6 weeks post T4 administration ]
- To achieve preliminary assessment of anti-tumour activity, using cross-sectional imaging to quantify objective responses [ Time Frame: up to 6 weeks post T4 administration ]
- To investigate tumour ErbB receptor phenotype, before and after administration of T4 immunotherapy [ Time Frame: up to 6 weeks post T4 administration ]
- To investigate immunomodulatory effects of metronomic cyclophosphamide on T4 immunotherapy [ Time Frame: up to 6 weeks post T4 administration ]Pre- and post-treatment absolute number of circulating T-regulatory cells will be compared.
- To investigate effect of T4 immunotherapy upon immune reactivity against endogenous tumour antigens [ Time Frame: up to 6 weeks post T4 administration ]ELISPOT will be performed on blood samples taken 3 days prior and 29 days after T4 administration to measure for MAGE-reactive T-cells.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01818323
|Contact: John Maher, MD PhD||(+44) 02071881468 ext firstname.lastname@example.org|
|Clinical Research Facility, Guy's Hospital||Recruiting|
|London, United Kingdom, SE1 9RT|
|Principal Investigator: John Maher|
|Principal Investigator:||John Maher, MD PhD||King's College London|