Long-term follow-up of zevor-cel in patients with relapsed/refractory multiple myeloma.

Patients with relapsed/refractory multiple myeloma (RRMM) frequently develop drug resistance, leading to poor survival outcomes. Zevorcabtagene autoleucel (zevor-cel or CT053) is a fully human B-cell maturation antigen, targeting chimeric antigen receptor (CAR) T-cell therapy for patients with RRMM. The phase 1 part of LUMMICAR study 1 was a single-arm, open-label, multi-center study conducted in China, enrolling patients with RRMM who received ≥3 prior regimens. Safety, tolerability, efficacy, and pharmacokinetics were evaluated. Fourteen patients (50% male) received single infusion of zevor-cel (100 × 106 [n = 3] and 150 × 106 CAR T cells [n = 11]). As of 22 February 2025, with the median follow-up duration of 53.3 months (range, 14.8-63.5), 13 (92.9%) patients experienced grade 1 or 2 cytokine release syndrome. No immune effector cell-associated neurotoxicity syndrome, delayed neurotoxicities, second primary malignancy, or other delayed adverse events were observed. There were 3 deaths, and none were zevor-cel-related. The objective response rate was 100% (95% confidence interval [CI], 76.8-100.0) and 11 (78.6%) patients achieved complete response or better, 13 (92.9%) with very good partial response or better response and 1 (7.1%) with partial response. The median duration of response was 24.94 months (95% CI, 14.03-45.86). The proportion of patients with a response lasting ≥36 months and ≥48 months were 41.7% and 15.6%, respectively. At 24, 36, 48, and 60 months after infusion, overall survival rates were 100%, 92.3%, 84.6%, and 76.9%, respectively. This 53.3-month median follow-up data of zevor-cel reaffirms the initial results with a manageable safety profile and compelling efficacy in RRMM. This trial was registered at www.clinicaltrials.gov (NCT03975907).