B细胞成熟抗原×CD3双特异性抗体Teclistamab在165例重度治疗过的复发或难治多发性骨髓瘤患者中展示了总有效率为63.0%的结果，该结果来自于1/2期MajesTEC-1研究。已知作为T细胞重定向的一种表现的细胞因子释放综合征（CRS）在165名患者中的119名患者（72.1%）观察到。患者在两次逐步剂量后（0.06和0.3 mg/kg）每周一次皮下注射Teclistamab 1.5 mg/kg。根据美国移植和细胞治疗学会的标准对CRS进行分级，并按照研究方案进行管理，包括使用托珠单抗和/或类固醇。大多数CRS发生在Teclistamab的逐步剂量方案期间，并且是1级（50.3%的患者）或2级（21.2%的患者）的；在一名合并有3级肺炎的患者中报告了一例3级CRS的单例病例。所有CRS病例均得到解决，并且没有导致治疗中断。总体而言，有33.3%的患者有>1个CRS事件；与未给予治疗时相比，当托珠单抗用于第一个CRS事件时，CRS复发的发生率降低了（20.0% vs. 62.2%）。肿瘤负担和细胞因子水平等基线特征似乎不能预测CRS的发生率或严重程度。该研究的结果支持对接受T细胞诱导的双特异性抗体治疗的患者进行预防性规划和及时管理CRS的需要。CRS干预使用托珠单抗似乎降低了患者经历后续CRS事件的可能性，而不会影响对Teclistamab的反应。在Teclistamab逐步剂量期间或给予下一剂量之前，确保患者的发热得到解决且没有感染迹象，以避免加重CRS。在基线特征中，包括肿瘤负担和细胞因子水平，在CRS的发生率或严重程度方面似乎不能进行明确的预测。©2023 Janssen制药公司。由Wiley Periodicals LLC代表美国癌症协会发表的《癌症》杂志。

Teclistamab, a B-cell maturation antigen × CD3 bispecific antibody, demonstrated an overall response rate of 63.0% in 165 heavily pretreated patients with relapsed or refractory multiple myeloma in the phase 1/2 MajesTEC-1 study. Cytokine release syndrome (CRS), a known manifestation of T-cell redirection, was observed in 119 of 165 patients (72.1%).Patients received once-weekly teclistamab 1.5 mg/kg subcutaneously after two step-up doses (0.06 and 0.3 mg/kg). CRS was graded according to American Society for Transplantation and Cellular Therapy criteria and managed according to the study protocol, including use of tocilizumab and/or steroids.Most cases of CRS occurred during the step-up dosing schedule of teclistamab and were grade 1 (50.3% of patients) or grade 2 (21.2% of patients); a single case of grade 3 CRS was reported in a patient with concurrent grade 3 pneumonia. All CRS cases resolved and none led to treatment discontinuation. Overall, 33.3% of patients had >1 CRS event; CRS recurrence was reduced when tocilizumab was administered for the first CRS event compared with when it was not (20.0% vs. 62.2%, respectively). Baseline characteristics such as tumor burden and cytokine levels did not appear to predict CRS incidence or severity.Findings of this study support the need for preemptive planning and prompt management of CRS in patients treated with T-cell-engaging bispecific antibodies. Intervention with tocilizumab for CRS appears to decrease the likelihood of patients experiencing subsequent CRS events without compromising response to teclistamab.Cytokine release syndrome (CRS), observed in 72.1% of patients treated with teclistamab in the MajesTEC-1 study, was mostly grade 1 or 2 and manageable, without requiring treatment discontinuation. Most CRS occurred during the step-up schedule, requiring vigilance during treatment initiation. Ensure fever is resolved and patients have no signs of infection before initiating the teclistamab step-up schedule or administering the next teclistamab dose, to avoid exacerbating CRS. Tocilizumab reduced the risk of subsequent CRS in patients receiving it for their first CRS event (20.0% vs. 62.2% in those not receiving it), without affecting response to teclistamab. No baseline characteristics, including tumor burden or cytokine levels, appeared to clearly predict for CRS occurrence or severity.© 2023 Janssen Pharmaceuticals. Cancer published by Wiley Periodicals LLC on behalf of American Cancer Society.