The U.S. Food and Drug Administration (FDA) issued a notice to the clinical stage biotechnology company, Adaptimmune, that a partial clinical hold was placed on the planned pivotal trial of NY-ESO SPEAR T-cell therapy for patients with myxoid round cell liposarcoma (MRCLS). The study has not yet recruited any patients.1
The partial clinical hold is not based on concerns over the immunotherapy’s safety. The FDA requested additional information on pharmaceutical quality and answers to specific trial design questions prior to the initiation of the study.
SPEAR T-cell therapy targets the NY-ESO cancer antigen, and the activity of this immunotherapy was demonstrated in other phase 1/2 studies in solid tumors and hematologic malignancies, including synovial sarcoma and multiple myeloma.
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Earlier in 2016, SPEAR T-cell therapy was granted orphan drug designation and Breakthrough Therapy designation by the FDA to accelerate the review process.
- Adaptimmune announces partial clinical hold of planned pivotal study of NY-ESO SPEAR® T-cell therapy in myxoid round cell liposarcoma. Adaptimmune. http://ir.adaptimmune.com/phoenix.zhtml?c=253991&p=irol-newsArticle&ID=2192667. Updated August 3, 2016. Accessed August 5, 2016.