NY-ESO-1c259T in Advanced NSCLC
Research type
Research Study
Full title
A Pilot Open-Label Clinical Trial Evaluating the Safety and Efficacy of Autologous T Cells Expressing Enhanced TCRs Specific for NY-ESO-1 in Subjects with Stage IIIb or Stage IV Non-Small Cell Lung Cancer (NSCLC)
IRAS ID
217767
Contact name
Martin Forster
Contact email
Sponsor organisation
Adaptimmune LLC
Eudract number
2016-002517-21
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 3 days
Research summary
Lung cancer is the leading cause of all cancer-related deaths. In a type of lung cancer known as non-small cell lung cancer (NSCLC), treatment responses in advanced cases have reached a plateau of approximately 25% – 35%. The 2 year survival rate remains short at 10%-15%.
Immunotherapy is a type of therapy which uses the patient’s immune system to fight their cancer. Central to the body's immune system is a type of blood cell, known as a T cell. T cells collected from the patient's blood can be genetically modified in a laboratory. Potentially the modification results in an enhanced ability of T cells to attack the patient's cancer cells. In this study the modified T cells are known as NY-ESO-1c259T - the investigational drug. The study will assess safety and efficacy of NY-ESO-1c259T in certain patients with advanced NSCLC.
Patients must be screened to check that they are of a particular blood type and also have a tumour which tests positive for proteins known as NY-ESO-1. The trial will enrol up to 10 adult patients.Summary:
1. Eligible patients undergo a procedure (taking 4-5 hours) to collect T cells from their blood.
2. The T cells are then genetically modified to produce the investigational drug,
NY-ESO-1c259T. This will be returned to the patient's bloodstream via an infusion.
3. Up to 3 days of chemotherapy are required to prepare the body for the infusion.
4. Following chemotherapy, the patient receives the NY-ESO-1c259T.
5. Patients are monitored closely under the follow-up schedule - this reduces to 6 monthly visits after 2 years.
5. Follow-up continues until the patient leaves the study or their cancer worsens.
Thereafter, the patient will be followed-up for 15 years for ongoing safety review.The potential role for immunotherapy and the unmet medical need provides the rationale for investigation of NY-ESO-1c259T in the advanced NSCLC population.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
17/LO/0275
Date of REC Opinion
19 Jul 2017
REC opinion
Further Information Favourable Opinion