A Pilot Study of NY-ESO-1c259T in Synovial Sarcoma
Research type
Research Study
Full title
A Pilot Study of Genetically Engineered NY-ESO-1 Specific NY-ESO-1c259T in HLA-A2+ Patients with Synovial Sarcoma
IRAS ID
195662
Contact name
Sandra Strauss
Contact email
Sponsor organisation
GSK
Eudract number
2015-005594-21
Clinicaltrials.gov Identifier
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
The purpose of this clinical trial is to test the safety and effectiveness of T cells engineered to recognise a peptide called NY-ESO-1 in patients with unresectable, metastatic or recurrent synovial sarcoma.
Synovial sarcoma (SS) is a subtype of soft tissue tumour that most commonly affects the extremities (legs and arms). It can occur at any age, but it is more common among teenagers and young adults and is rare with only about 1 to 3 in a million people being diagnosed each year. Patients with localised disease at diagnosis can be cured with surgery and radiotherapy but patients with unresectable disease or metastases (most commonly the lungs) have a poor prognosis. Chemotherapy is given to control the disease but is not usually deemed to be curative.
Immunotherapy is a type of cancer therapy that uses the power of a patient’s immune system to fight their disease. T cells are a type of white blood cell which play a central role in the body’s immune response. T cells can be genetically engineered to express certain receptors able to recognize specific tumour antigens and trigger an immune response to attack a tumour.
Adaptimmune have developed a T cell receptor (TCR) that targets the NY-ESO-1 antigen, present at high levels in most patients with SS. This trial will enrol approximately 60 patients 4 years of age or older with NY-ESO-1 expressing unresectable, metastatic or recurrent synovial sarcoma. A blood (leukapheresis) sample will be taken and some of the patient’s own (autologous) T cells gene modified for a NY-ESO-1 specific HLA-A2 restricted T cell receptor. Following cell manufacture, patients will receive a preparative chemotherapy regimen and then an infusion of their modified T cells thus initiating an immune attack specific to the synovial sarcoma. Early clinical studies have shown promising results, this study is designed to extend those studies and will last at least 5 years. Long-term follow-up of patients will be carried out for 15 years post-infusion.REC name
South Central - Oxford A Research Ethics Committee
REC reference
16/SC/0331
Date of REC Opinion
18 Aug 2016
REC opinion
Further Information Favourable Opinion