NCT01795976

NY-ESO-1 T Cells in OG Cancer

A Phase II Trial to Assess the Activity of NY-ESO-1 Targeted T Cells in Advanced Oesophagogastric Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Fiona Thistlethwaite · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a trial of adoptive T cell therapy using the patient's own T cells, genetically engineered to target the tumour associated antigen NY-ESO-1 (New York esophageal squamous cell carcinoma 1). Eligible patients will undergo leukapheresis (a process to remove white blood cells) to retrieve sufficient T cells which will be gene modified and expanded in the laboratory. Patients will undergo preconditioning chemotherapy with cyclophosphamide (60mg/kg) day -7 and day -6, followed by fludarabine (25mg/m2) day -5 to day -1. The NY-ESO-1 gene modified cells will be re-infused on day 0 and the patients will receive up to 14 doses of intravenous Interleukin2 (100000 U/kg) from day 0 to day 4. The primary objective of response rate according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 criteria will be assessed by CT scans carried out at week 6, week 12 and at 12 weekly intervals thereafter.

Conditions

• Oesophageal Cancer

Interventions

Type	Name	Description
GENETIC	NY-ESO-1 T cells
DRUG	cyclophosphamide	cyclophosphamide 60mg/kg/day day -7 and day -6
DRUG	Fludarabine	Fludarabine given 25mg/m2 day -5 to day -1
BIOLOGICAL	Interleukin 2	Interleukin 2 (IL2) immunotherapy given day 0 to day 6

Timeline

• Start date: 2014-10-01
• Primary completion: 2017-11-01
• Completion: 2017-11-01
• First posted: 2013-02-21
• Last updated: 2018-08-07

Locations

1 site across 1 country: United Kingdom