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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.