Berdeja JG, Madduri D, Usmani SZ, et al. - This single-arm, open-label, phase 1b/2 study, CARTITUDE-1, was conducted to evaluate ciltacabtagene autoleucel (cilta-cel), a chimeric antigen receptor T-cell therapy with two B-cell maturation antigen-targeting single-domain antibodies, for its safety as well as clinical activity in patients suffering from relapsed or refractory multiple myeloma with poor prognosis. In eligible patients, a single cilta-cel infusion (target dose 0·75 × 10 ⁶ CAR-positive viable T cells per kg) was delivered 5–7 days post-initiation of lymphodepletion. An overall response rate of 97% was achieved; stringent complete response was seen in 65 (67%); time to first response was 1 month. The 12-month progression-free rate and overall survival rate were estimated to be 77% and 89%, respectively. Findings demonstrated early, deep, and durable responses were conferred by a single cilta-cel infusion, administered at the target dose of 0·75 × 10 ⁶ CAR-positive viable T cells per kg, in heavily pretreated patients with multiple myeloma. This treatment showed a manageable safety profile. This study’s results form the basis for recent regulatory submissions.