ARTICLE | Clinical News

NY-ESO SPEAR T-cell therapy: Pivotal trial hold

August 15, 2016 7:00 AM UTC

Adaptimmune said FDA placed a partial clinical hold on the planned pivotal trial of NY-ESO SPEAR T-cell therapy to treat MRCLS. The company said FDA requested “additional CMC information and answers to certain trial design questions.” Adaptimmune said the hold is not based on safety concerns and that it plans to provide a full response to FDA “shortly.” The company plans to start the trial in late 2016 or early next year. ...