Source: Healio News
The FDA granted orphan drug designation to GC012F, a novel chimeric antigen receptor T-cell therapy for the treatment of relapsed or refractory multiple myeloma.
GC012F (Gracell Biotechnologies) is an autologous, gene-edited, bispecific CAR-T that targets the B-cell maturation antigen (BCMA) and CD19 proteins on the surface of cancer cells.
The therapy is manufactured using Gracell’s proprietary FasT CAR platform, which produces patient-derived therapies within 24 hours followed by a quality-control testing period typical of other CAR T-cell therapies.
“We are very excited about being