复发/难治性多发性骨髓瘤患者感染的风险增加。 teclistamab 是第一个被批准用于三类暴露复发/难治性多发性骨髓瘤的 B 细胞成熟抗原导向双特异性抗体，在 1/2 期 MajesTEC-1 研究中检查了治疗期间的感染。患者 (N = 165) 接受了治疗在逐步给药方案（0.06 mg/kg 和 0.3 mg/kg，每次间隔 2-4 天）后，每周皮下注射 teclistamab 1.5 mg/kg。经常监测患者的感染情况；预防和管理按照机构指南进行。中位随访时间为 22.8 个月（范围为 0.3-33.6），有 132 名患者 (80.0%) 报告感染。 91名患者（55.2%）发生3/4级感染，包括COVID-19（21.2%）、呼吸道感染（19.4%）、耶氏肺孢子虫肺炎（4.2%）、病毒感染（4.2%）和胃肠道感染（1.2%）。 %）。 21 名患者死于感染（其中 18 名患者死于 COVID-19）。任何级别和 3 至 5 级感染首次发病的中位时间分别为 1.7 个月和 4.2 个月。总体而言，70.9% 的患者基线后免疫球蛋白 G (IgG) 水平≥1 <400 mg/dL； IgG <400 mg/dL 的中位时间为 1.2 个月（范围：0.2-19.8），46.1% 接受了 ≥1 剂 IgG 替代疗法。 65.5% 的患者出现 3/4 级中性粒细胞减少症（出现 ≥3 级中性粒细胞减少症/发热性中性粒细胞减少症的中位时间为 2.3 个月 [范围，0-18.1]）。基于 B 细胞成熟抗原靶向双特异性抗体的感染概况，例如作为 teclistamab，建议临床医生和患者在整个治疗过程中对一系列感染类型保持警惕，以便及时干预。对感染、低丙种球蛋白血症和中性粒细胞减少症进行适当的筛查、预防和管理非常重要。NCT03145181/NCT04557098 (ClinicalTrials.gov) 简明语言摘要：在开始 teclistamab 之前，患者应及时接种疫苗（包括 COVID-19）并进行筛查乙型和丙型肝炎以及艾滋病毒。不应将 Teclistamab 给予患有任何活动性感染的患者。应按照机构指南施用预防性抗菌药物。建议在 teclistamab 治疗期间预防耶氏肺孢子虫肺炎和单纯疱疹/水痘带状疱疹病毒。在整个 teclistamab 治疗过程中，应继续密切监测感染和免疫球蛋白 G (IgG) 水平。应使用 IgG 替代品（每 3-6 周一次）来维持 IgG ≥400 mg/dL。对于 ≥3 级中性粒细胞减少症伴感染/发热和 4 级中性粒细胞减少症，应考虑生长因子。© 2023 作者。 《癌症》由 Wiley periodicals LLC 代表美国癌症协会出版。

Patients with relapsed/refractory multiple myeloma are at increased risk of infection. Infections during treatment with teclistamab, the first B-cell maturation antigen-directed bispecific antibody approved for triple-class-exposed relapsed/refractory multiple myeloma, was examined in the phase 1/2 MajesTEC-1 study.Patients (N = 165) received subcutaneous teclistamab 1.5 mg/kg weekly after a step-up dosing schedule (0.06 mg/kg and 0.3 mg/kg, each separated by 2-4 days). Patients were monitored frequently for infections; prophylaxis and management were per institutional guidelines.At a median follow-up of 22.8 months (range, 0.3-33.6), infections were reported in 132 patients (80.0%). Grade 3/4 infections occurred in 91 patients (55.2%), including COVID-19 (21.2%), respiratory infections (19.4%), Pneumocystis jirovecii pneumonia (4.2%), viral infections (4.2%), and gastrointestinal infections (1.2%). Twenty-one patients died from infections (18 from COVID-19). Median time to first onset of any-grade and grade 3 to 5 infections was 1.7 and 4.2 months, respectively. Overall, 70.9% of patients had ≥1 postbaseline immunoglobulin G (IgG) level <400 mg/dL; median time to IgG <400 mg/dL was 1.2 months (range, 0.2-19.8) and 46.1% received ≥1 dose of IgG replacement. Grade 3/4 neutropenia occurred in 65.5% of patients (median time to grade ≥3 neutropenia/febrile neutropenia was 2.3 months [range, 0-18.1]).Based on the infection profile of B-cell maturation antigen-targeted bispecific antibodies such as teclistamab, it is recommended that clinicians and patients remain vigilant for a range of infection types throughout treatment to facilitate prompt intervention. Appropriate screening, prophylaxis, and management of infections, hypogammaglobulinemia, and neutropenia are important.NCT03145181/NCT04557098 (ClinicalTrials.gov) PLAIN LANGUAGE SUMMARY: Before starting teclistamab, patients should be up to date with vaccinations (including COVID-19) and screened for hepatitis B and C and HIV. Teclistamab should not be given to patients with any active infections. Prophylactic antimicrobials should be administered per institutional guidelines. Prophylaxis for Pneumocystis jirovecii pneumonia and herpes simplex/varicella zoster virus is recommended during teclistamab treatment. Close monitoring of infections and immunoglobulin G (IgG) levels should continue throughout teclistamab treatment. IgG replacement (administered every 3-6 weeks) should be used to maintain IgG ≥400 mg/dL. Growth factors should be considered for grade ≥3 neutropenia with infection/fever and grade 4 neutropenia.© 2023 The Authors. Cancer published by Wiley Periodicals LLC on behalf of American Cancer Society.