肿瘤细胞治疗研究
英文原题：A combination of humanized anti-BCMA and murine anti-CD38 CAR-T cell therapy in patients with relapsed or refractory multiple myeloma.
A combination of humanized anti-BCMA and murine anti-CD38 CAR-T cell therapy in patients with relapsed or refractory multiple myeloma.
研究纳入22例R/RMM患者，中位年龄56岁，中位既往治疗线数为8。
CAR-T（CAR-T）细胞是血液系统恶性肿瘤的一种有前景的治疗方法。我们评估了人源化抗BCMA和鼠源抗CD38 CAR-T细胞联合治疗在复发或难治性多发性骨髓瘤（R/RMM）患者中的安全性和疗效。本研究纳入22例R/RMM患者，中位年龄为56岁，中位既往治疗线数为8。两种CAR-T细胞的输注剂量均为2.0 10 6/kg。总缓解率（ORR）为90.9%，其中12例患者（54.5%）达到严格完全缓解/完全缓解（sCR/CR）。24个月总生存（OS）率为56.6%，无进展生存（PFS）率为48.7%。1-2级细胞因子释放综合征（CRS）发生于16例患者（72.7%），3级发生于6例患者（27.3%）。1-2级免疫效应细胞相关神经毒性综合征（ICANS）发生于3例患者（13.6%）。该联合治疗在R/RMM患者中具有潜力。试验注册：患者纳入注册号为ChiCTR1800017051的临床试验。
Chimeric antigen receptor T (CAR-T) cells are a promising approach in hematopoietic malignancies. We evaluated the safety and efficacy of a combination of humanized anti-BCMA and murine anti-CD38 CAR-T cell therapy in patients with relapsed or refractory multiple myeloma (R/RMM). Twenty-two R/RMM patients, with a median age of 56 years and a median number of previous therapies of 8, were included in the study. Both CAR-T cells infusion doses were 2.0 10 6 /kg. The overall response rate (ORR) was 90.9%, with 12 patients (54.5%) achieving a strict complete response/complete response (sCR/CR). The 24-month overall survival (OS) rate was 56.6%, and the progression-free survival (PFS) rate was 48.7%. Cytokine release syndrome (CRS) of grades 1-2 occurred in 16 patients (72.7%) and of grade 3 in six patients (27.3%). Immune effector cell-associated neurotoxic syndrome (ICANS) of grades 1-2 occurred in three patients (13.6%). The combination therapy is potential in R/RMM patients. Trial registration: The patients were enrolled in clinical trials registered as ChiCTR1800017051.
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