Allogeneic CAR T-Cell Therapy to Enter Phase I Trial in Multiple Myeloma
Posted: Thursday, April 11, 2019
The U.S. Food and Drug Administration (FDA) approved an investigational new drug application to initiate a phase I clinical trial in multiple myeloma for UCARTCS1, reportedly the first allogeneic chimeric antigen receptor (CAR) T-cell therapy for multiple myeloma to enter clinical development. The investigational new drug application for UCARTCS1 was filed on December 28, 2018, and approved by the FDA within a month, on January 25, 2019.
UCARTCS1 is an allogeneic, off-the-shelf, gene-edited T-cell product candidate designed for the treatment of multiple myeloma. It is based on a tailored manufacturing process that removes both the CS1 antigen and the T-cell receptor from the T-cell surface using gene-editing technology before adding the CS1 CAR construct. The UCART is designed to have a lymphodepleting effect, and the CAR T-cell cross reaction is suppressed.
