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
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.
科研通智能强力驱动
Strongly Powered by AbleSci AI