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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
cyclophosphamide 60mg/kg/day day -7 and day -6
Fludarabine given 25mg/m2 day -5 to day -1
Interleukin 2 (IL2) immunotherapy given day 0 to day 6
The Christie NHS Foundation Trust
Manchester, United Kingdom
Response rate to New York esophageal squamous cell carcinoma (NYESO) T cells
To evaluate the response rate in Oesophagogastric cancer patients who are New York esophageal squamous cell carcinoma 1 (NY-ESO-1)and Human Leukocyte Antigen serotype "A" serotype group (HLA-A2) positive to adoptive cell therapy targeted to NY-ESO-1.
Time frame: 6 weeks post treatment
Response rate to NYESO T cells
To evaluate the response rate in Oesophagogastric cancer patients who are NY-ESO-1 and HLA-A2 positive to adoptive cell therapy targeted to NY-ESO-1.
Time frame: 12 weeks post treatment
Response rate to NYESO T cells
To evaluate the response rate in Oesophagogastric cancer patients who are NY-ESO-1 and HLA-A2 positive to adoptive cell therapy targeted to NY-ESO-1.
Time frame: 24 weeks post treatment
Response rate to NYESO T cells
To evaluate the response rate in Oesophagogastric cancer patients who are NY-ESO-1 and HLA-A2 positive to adoptive cell therapy targeted to NY-ESO-1.
Time frame: 36 weeks post treatment
Response rate to NYESO T cells
To evaluate the response rate in Oesophagogastric cancer patients who are NY-ESO-1 and HLA-A2 positive to adoptive cell therapy targeted to NY-ESO-1.
Time frame: 48 weeks post treatment
Feasibility and tolerability of NY-ESO-1 targeted cell therapy
Evaluation of feasibility and tolerability of adoptive cell therapy targeted to NY-ESO-1 in Oesophagogastric cancer patients who are NY-ESO-1 and HLA-A2 positive.
Time frame: Feasibility will be assessed proceed to full therapy (Study day 6).
Evaluation of the progression free survival
measuring length of time from point of cell infusion until disease progression.
Time frame: Until progression occurs, estimated to be average of 12 months per patient.
Feasibility and tolerability of NY-ESO-1 targeted cell therapy
Evaluation of feasibility and tolerability of adoptive cell therapy targeted to NY-ESO-1 in Oesophagogastric cancer patients who are NY-ESO-1 and HLA-A2 positive.
Time frame: Tolerability will be assessed for follow-up period, estimated to be average of 12 months per patient.
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