drugset / Trial / NCT01795976

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.

Timeline

Start
2014-10
Primary completion
2017-11
Completion
2017-11

Drugs

EvaluationDrugModalityDoseRoute
Subject NY-ESO-1 T cells Cell therapy
Background Cyclophosphamide Other / unclassified 60 mg/kg
Background Fludarabine Small molecule 25 mg/m2
Background aldesleukin Protein / enzyme biologic 100000 iu/kg Intravenous

Indications