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.
Phase:
Phase 2
Details
Lead Sponsor:
Fiona Thistlethwaite
Collaborators:
Erasmus Medical Center Karolinska University Hospital Ospedale San Raffaele The Christie NHS Foundation Trust The Netherlands Cancer Institute University College London Hospitals