Anti‐CD19 and anti‐BCMA CAR T cell therapy followed by lenalidomide maintenance after autologous stem‐cell transplantation for high‐risk newly diagnosed multiple myeloma

医学 来那度胺 多发性骨髓瘤 细胞因子释放综合征 自体干细胞移植 内科学 肿瘤科 移植 微小残留病 不利影响 外科 嵌合抗原受体 骨髓 免疫疗法 癌症
作者
Xiaolan Shi,Lingzhi Yan,Jingjing Shang,Liqing Kang,Zhiqiang Yan,Song Jin,Mingqing Zhu,Huirong Chang,Fei‐Ran Gong,Jiazi Zhou,Guanghua Chen,Jinlan Pan,Dandan Liu,Xiaming Zhu,Fang Tang,Minghong Liu,Wei Liu,Feirong Yao,Lei Yu,Depei Wu,Chengcheng Fu
出处
期刊:American Journal of Hematology [Wiley]
卷期号:97 (5): 537-547 被引量:32
标识
DOI:10.1002/ajh.26486
摘要

Few prospective studies have examined posttransplant chimeric antigen receptor (CAR) T cell infusion as candidates for front-line consolidation therapy for high-risk multiple myeloma (MM) patients. This single-arm exploratory clinical trial is the first to evaluate the safety and efficacy of sequential anti-CD19 and anti-BCMA CAR-T cell infusion, followed by lenalidomide maintenance after autologous stem cell transplantation (ASCT), in 10 high-risk newly diagnosed multiple myeloma (NDMM) patients. The treatment was generally well tolerated, with hematologic toxicities being the most common grade 3 or higher adverse events. All patients had cytokine release syndrome (CRS), which was grade 1 in 5 patients (50%) and grade 2 in 5 patients (50%). No neurotoxicity was observed after CAR-T cell infusion. The overall response rate was 100%, with the best response being 90% for a stringent complete response (sCR), and 10% for a complete response (CR). At a median follow-up of 42 (36-49) months, seven (70%) of 10 patients showed sustained minimal residual disease (MRD) negativity for more than 2 years. The median progression-free survival (PFS) and overall survival (OS) were not reached. Although the sample size was small and there was a lack of control in this single-arm study, the clinical benefits observed warrant ongoing randomized controlled trials.
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