Three-Year Follow-up on Efficacy and Safety Results from Phase 1 Lummicar Study 1 of Zevorcabtagene Autoleucel in Chinese Patients with Relapsed or Refractory Multiple Myeloma

作者：Chengcheng Fu, Wen-Ming 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, Wei Zheng, Huamao Wang, Zonghai Li · 发表于：Blood · 年份：2023 · DOI：10.1182/blood-2023-184373 · 被引用次数：23 · 研究领域：CAR-T cell therapy research、Biosimilars and Bioanalytical Methods

Introduction: Phase 1b of LUMMICAR STUDY 1 was conducted in China (NCT03975907) for zevorcabtagene autoleucel (zevor-cel, CT053), a fully human autologous chimeric antigen receptor (CAR) T-cell therapy comprising a B-cell maturation antigen-specific single-chain variable fragment, in patients with relapsed or refractory multiple myeloma (RRMM). Previously disclosed 1-year follow-up data (ASH 2021 Abstract 2821) demonstrated a tolerable safety profile and deep and durable responses in 14 patients. Here, we present the updated results with 3 years of follow-up after the last patient was infused. Methods: Patients were eligible to be enrolled with a diagnosis of RRMM, ECOG score of 0 or 1, and they had received at least 3 prior regimens including at least one proteasome inhibitor and one immunomodulatory drug. A single infusion of zevor-cel (two dose levels, 100 × 10 6 CAR + T cells and 150 × 10 6 CAR + T cells) was administered 5-7 days after the start of lymphodepletion. Response was assessed by investigator per IMWG 2016 criteria. Bone marrow aspirates were tested for minimal residual disease (MRD) by the EuroFlow assay with a minimum sensitivity of 1 in 10 5 nucleated cells. Results: Starting July 23, 2019, 14 patients with a median age of 54 years (range 34, 62), received a single infusion of zevor-cel (100 × 10 6 CAR + T cells in 3 patients, 150 × 10 6 CAR + T cells as the recommended phase 2 dose in 11 patients). The median number of prior lines of therapy was 6. A total ...