Durcabtagene autoleucel (PHE885), a rapid-manufactured BCMA CAR-T, posts 98% ORR and 55% sCR in r/r multiple myeloma

Durcabtagene autoleucel (also known as PHE885) is an autologous BCMA-directed CAR-T made on a rapid manufacturing platform intended to preserve stem-like T-cell features. In Part A of a Phase 1, dose-escalation study in relapsed/refractory multiple myeloma (NCT04318327), manufacturing succeeded in 55/55 patients with a median vein-to-vein time of 24 days; efficacy across treated patients was ORR 98%, sCR 55%, and MRD negativity 80% among evaluable patients (35/44). Safety was described as having no unexpected findings and no delayed neurotoxicity; as a benchmark, approved BCMA CAR-Ts in similar late-line r/r MM historically deliver ~73% ORR for ide-cel and ~98% ORR with ~83% sCR for cilta-cel, but cilta-cel carries meaningful CRS/ICANS risk in labeling-era datasets (CRS common; ICANS reported).