In November, CRISPR Therapeutics was handed a Regenerative Medicine Advanced Therapy designation for its chimeric antigen receptor (CAR)-T cell therapy CTX110 from the US Food and Drug Administration (FDA) — a notable milestone for off-the-shelf immune-cell therapy. The agency’s ruling came shortly after CRISPR Therapeutics reported promising — though far from perfect — interim data from an ongoing phase 1 trial of the investigational allogeneic CAR-T cell therapy, which is in development for CD19+ B-cell malignancies. Samarth Kulkarni, CRISPR Therapeutics’ CEO, describes the data readout as ‘a coming of age for allogeneic cell therapy’, although a single patient who received the highest dose on the trial died from immune effector cell–associated neurotoxicity syndrome accompanied by human herpes virus-6 reactivation. doi: https://doi.org/10.1038/d41587-021-00027-1
https://www.nature.com/articles/d41587-021-00027-1
Off-the-shelf, gene-edited CAR-T cells forge ahead, despite safety scare
