Zevorcabtagene autoleucel (zevor-cel) is a fully human, autologous chimeric antigen receptor (CAR) T-cell therapy targeting B-cell maturation antigen. It gained regulatory approval in China in 2024 for use in adults with relapsed/refractory multiple myeloma (RRMM). The LUMMICAR STUDY 1 trial was a phase 2, single-arm, open-label study conducted at 23 clinical sites across China. Enrolled individuals were adults between 18 and 75 years old diagnosed with RRMM, who had measurable disease after receiving three or more previous lines of therapy. They were required to have adequate organ function, sufficient bone marrow reserve, and an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Those with any prior exposure to CAR T-cell therapy or BCMA-targeted agents were not permitted to participate. The main endpoint was the objective response rate (ORR) evaluated by an Independent Review Committee. Additional endpoints covered investigator-determined ORR, rates of complete response (CR) and stringent complete response (sCR), duration of response (DOR), achievement of minimal residual disease negativity, safety assessments (including the occurrence and severity of adverse events), and the pharmacokinetic behavior of zevor-cel. A total of 125 patients underwent apheresis, 105 underwent lymphodepletion, and 102 ultimately received zevor-cel infusion. These participants had a median age of 59.5 years (range: 38–75), with 53.9% male and 46.1% female. The ORR was 92.2% (95% confidence interval: 85.13–96.55), including 68.6% (70 patients) who reached sCR and 2.9% (3 patients) who attained CR. With a median follow-up period of 20.3 months (interquartile range: 12.5–23.8), 44.1% (45 patients) experienced progression-free survival (PFS) events and 19.6% (20 patients) had overall survival (OS) events; however, data for DOR, PFS, and OS had not yet reached maturity. Cytokine release syndrome developed in 90.2% (92 patients), of which 6.9% (7 patients) were grade 3 or 4. Immune effector cell-associated neurotoxicity syndrome occurred in only two patients, both at grade 1, with no reports of grade 3 or higher neurotoxicity linked to zevor-cel. In heavily pretreated patients with RRMM, zevor-cel delivers profound and durable responses with an acceptable safety profile.
