ARTICLE | Clinical News

FDA lifts hold on Adaptimmune T-cell therapy

November 11, 2016 12:01 AM UTC

Adaptimmune Therapeutics plc (NASDAQ:ADAP) said FDA lifted a partial clinical hold on the company's planned trial of NY-ESO SPEAR T-cell therapy to treat myxoid round cell liposarcoma (MRCLS). Adaptimmune announced the hold in early August, saying FDA had requested "additional CMC information and answers to certain trial design questions."

On a conference call Thursday, CEO James Noble said the company has amended the study's protocol. It originally proposed a pivotal trial design, but has now converted the study into a pilot trial that is to enroll up to 15 patients. Screening is to begin around YE16...