Equecabtagene Autoleucel in Patients With Relapsed or Refractory Multiple Myeloma

作者：Chunrui Li, Keshu Zhou, Yongxian Hu, Dehui Zou, Lijuan Chen, Bing Chen, Jing Liu, Xi Zhang, Hanyun Ren, Kai Hu, Peng Liu, Jian‐Qing Mi, Zhenyu Li, Kaiyang Ding, Di Wang, Wen Wang, Songbai Cai, Jianyong Li, Yongping Song, He Huang, Lugui Qiu · 发表于：JAMA Oncology · 年份：2024 · DOI：10.1001/jamaoncol.2024.4879 · 被引用次数：22 · 研究领域：CAR-T cell therapy research、Multiple Myeloma Research and Treatments、Cancer Immunotherapy and Biomarkers

Importance: Equecabtagene autoleucel (eque-cel), a fully human-derived B-cell maturation antigen-targeting chimeric antigen receptor (CAR) T-cell therapy, has exhibited potential for the treatment of relapsed or refractory multiple myeloma (RRMM), and further investigation in a larger cohort is necessary. Objective: To evaluate whether eque-cel can benefit patients with RRMM and determine the overall response rate postinfusion. Design, Setting, and Participants: The FUMANBA-1 trial was a single-arm, open-label, phase 1b/2 trial that evaluated eque-cel in adult patients with RRMM. Enrollment began in April 2020, and patients who received eque-cel will be monitored for a minimum of 15 years following the infusion. As of September 2022, patients with heavily pretreated RRMM who received at least 3 prior courses of therapy from 14 centers were enrolled. Data were analyzed from April 2020 to September 2022. Interventions: Patients received a single infusion of eque-cel at 1.0 × 106 CAR-positive T cells/kg after the lymphodepletion. Main Outcomes and Measures: Efficacy was the primary objective, and safety, pharmacokinetics, and pharmacodynamics were secondary objectives. Results: Of 103 patients who received an eque-cel infusion, 55 (53.4%) were male, and the median (range) age was 58 (39-70) years. A total of 101 patients were evaluable for efficacy. At a median (range) follow-up of 13.8 (0.4-27.2) months, the overall response rate was 96.0% (97 of 101), with 74.3% (75 of 103) ac...