Adaptimmune Reports Partial Clinical Hold On NY-ESO SPEAR T-cell Therapy Study

(RTTNews) - Adaptimmune Therapeutics plc (ADAP) announced it has received notice from the U.S. FDA that a partial clinical hold has been placed on its planned pivotal study of NY-ESO SPEAR T-cell therapy in myxoid round cell liposarcoma. The company said the FDA has requested additional CMC information and answers to certain trial design questions prior to the trial start.

James Noble, Adaptimmune CEO, said: "We have been in dialogue with the FDA since achieving breakthrough status earlier this year and this partial clinical hold requires a number of questions to be answered before we can start a new MRCLS trial intended to be used for registration purposes. We will be providing a full response to the FDA shortly and will update the markets when we have further news to report."