Phase 1b-2 trial of equecabtagene autoleucel in patients with relapsed or refractory multiple myeloma

Equecabtagene autoleucel (eque-cel) is the first fully human derived BCMA-targeting CAR T-cell therapy. The multicenter phase 1b-2 FUMANBA-1 trial in China evaluated eque-cel for heavily pretreated relapsed or refractory multiple myeloma (RRMM). Among 116 patients undergoing apheresis, 103 received a single eque-cel infusion at 1.0 x 10⁶ CAR-positive T cells/kg. A total of 101 patients were evaluable for efficacy. The overall response rate was 96.0%, with complete response or better in 74.3%. Among the 12 patients who had prior CAR T-cell treatment, 75% achieved a response. Median progression-free survival was not reached during median 13.8 months of follow-up (range 0.4-27.2) with 12-months PFS rate of 78.8% (95% CI 68.6-86.0). Minimal residual disease negativity at a sensitivity threshold of 10^-5 was achieved by 95%. Adverse events were favorable: 93.2% experienced CRS which was grade 1 or 2 in 92.3%, and 1.9% experienced ICANS (all grade 1 or 2). Only 19.4% developed antidrug antibodies. The authors conclude that eque-cel led to early, deep, and durable responses in patients with heavily pretreated RRMM, with a manageable safety profile.