Adaptimmune Therapeutics has started a Phase I/II trial of its affinity-enhanced T-cell therapy, which targets the NY-ESO-1 cancer antigen in patients with Stage IIIb or Stage IV non-small cell lung cancer (NSCLC).
The UK-based company is developing the affinity enhanced T-cell therapy targeting NY-ESO-1 under a collaboration agreement with GlaxoSmithKline (GSK).
The trial will include ten patients with locally advanced or metastatic NSCLC whose disease has progressed or not responded to prior therapies.
The company intends to start dosing patients shortly.
Adaptimmune chief medical officer Dr Rafael Amado said: "Lung cancer is the most common cancer worldwide and it is the leading cause of all cancer-related deaths, responsible for approximately one in five cancer deaths.
"NSCLC accounts for the vast majority of these cancer deaths and thus represents a great unmet medical need.
"Our NY-ESO TCR therapeutic candidate is being studied in a number of solid tumors and haematological malignancies including synovial sarcoma, multiple myeloma, melanoma, ovarian cancer and gastric and esophageal cancer.
"This new study marks an important step toward further elucidating the tolerability profile and anti-cancer activity of our promising therapeutic candidate in another cancer, and towards potentially reaching our goal of offering cancer patients an efficacious alternative therapy to current treatments."
Patients with the HLA-A*0201, HLA-A*0205, and / or HLA-A*0206 allele, whose tumour expresses the NY-ESO-1 tumour antigen, will be eligible to receive a single dose of autologous genetically modified T-cells. These will express affinity optimised TCRs specific for NY-ESO-1.
The trial’s primary objective is to evaluate the safety and tolerability of the company’s affinity enhanced T-cell therapy.
The secondary objectives of the trial include evaluation of efficacy, measurement of genetically modified cells’ persistence in the body, and evaluations of the phenotype and functionality of cells isolated from peripheral blood or tumour post infusion.