Year: 2025
Type: article
Study design: Clinical Trial
Abstract: ABSTRACT: 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).
Source: Blood Advances
Authors: Chengcheng Fu, Wenming Chen, Zhen Cai, Lingzhi Yan, Huijuan Wang, Jingjing Shang, Yin Wu, Shuang Yan, Wen Gao, Xiaolan Shi, Xiaoyan Han, Fang Tang, Gaofeng Zheng, Yanling Wen, Xingxing Meng, Daijing Yuan, Huamao Wang, Zonghai Li
Language: English
Topic: CAR-T cell therapy research
Subfield: Oncology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,800
OpenAlex ID: W4415675916
