Adaptimmune has opened a Phase 1/2, dual site, two-cohort, open-label clinical trial in multiple myeloma at the University of Maryland and the University of Pennsylvania testing its enhanced T cell receptor T cell therapy.
This trial is designed to investigate the safety, bioactivity, and anti-tumor effect of infusionof patients’ own T cells that have been genetically modified to express a high affinity T cell receptor (TCR) specific for a type of tumor antigen (protein) known as a cancer testis antigen (CT antigen). The aim of the trial is to improve the anti-tumor efficacy of the T cell infusion by genetically redirecting the T cells to specifically recognize the patients’ tumor. .
During the trial, TCRs that have been developed using Adaptimmune’s TCR enhancement technology will be deployed to target two CT antigens called Mage-A3/6 and NYESO-1. T cell manufacturing will be performed at the clinical cell and vaccine production facility at the Perelman School of Medicine at the University of Pennsylvania.
With standard therapy, long- term response rates for multiple myeloma are low, and the median survival for patients with this disease is 3 to 5 years. The clinical trial focuses on this unmet medical need and will include patients who have received prior treatment for their myeloma and who are eligible for an autologous stem cell transplant (ASCT). ASCT is the transplant of a patient’s own stem cells. Infusion of the CT antigen-specific T cells will occur just following ASCT.
A total of 12 patients will be enrolled in the trial over a period of two years, with six patients participating in each of the NYESO-1 and MAGE-A3/6 cohorts in accordance with a genetic randomization scheme based on a patient’s immune system (HLA-A) and tumor antigen status.
Release Date: May 26, 2011
Filed Under: Drug Discovery