NY-ESO SPEAR T-cell therapy: Phase I/IIa amended

Adaptimmune amended the preconditioning regimen of an open-label, U.S. Phase I/IIa trial of NY-ESO SPEAR T cell therapy after the company observed no objective clinical responses in the trial’s first iteration. Patients will now receive fludarabine plus cyclophosphamide, rather than cyclophosphamide alone, as a preconditioning regimen. The company said fludarabine “appears to be required for expansion, response and persistence of transduced cells.” Adaptimmune said the trial is expected to enroll up to 10 more patients under the revised protocol. It is enrolling patients with an HLA-A*0201, HLA-A*0205 and/or HLA-A*0206 allele and whose tumor expresses NY-ESO-1. ...