在复发性或耐火性多发性髓瘤中,talquetamab加上teclistamab
Yael C Cohen1, Hila Magen1, Moshe Gatt1
1From Tel Aviv Sourasky Medical Center (Y.C.C., I.A.), and the Faculty of Medical and Health Sciences, Tel Aviv University (Y.C.C., H.M., I.A.), Tel Aviv, Chaim Sheba Medical Center, Ramat Gan (H.M.), and Hadassah Hebrew University Medical Center, Jerusalem (M.G.) - all in Israel; McGill University and McGill University Health Centre, Montreal (M.S.), and Alberta Health Services, Edmonton (M.P.C.) - all in Canada; Samsung Medical Center, Sungkyunkwan University School of Medicine (K.K.), Seoul St. Mary's Hospital, Catholic University of Korea (C.-K.M.), and Seoul National University College of Medicine (S.-S.Y.) - all in Seoul, South Korea; Hospital Universitario Marqués de Valdecilla, Instituto de Investigación Sanitaria Valdecilla, Universidad de Cantabria, Santander (E.M.O.), Cancer Center Clínica Universidad de Navarra, Center for Applied Medical Research, Pamplona (P.R.-O.), Institut Català d'Oncologia, Josep Carreras Leukemia Research Institute, and the Hospital Germans Trias i Pujol, Barcelona (A.O.), START Madrid-Fundación Jiménez Díaz Early Phase Unit, University Hospital Fundación Jiménez Díaz, Madrid (D.M.), and the University Hospital of Salamanca, Institute for Biomedical Research of Salamanca, the Salamanca Cancer Research Center, and Centro de Investígación Biomédica en Red Cáncer, Salamanca (M.-V.M.) - all in Spain; Janssen Research and Development, Spring House, PA (N.A.Q.C., A.K., M.K., M.R.P., E.S., B.H., J.V., A.B.); and Janssen Research and Development, Allschwil, Switzerland (L.D.S.).
塔尔基塔马布加上特克利斯塔马布在复发性/耐药性多发性骨髓瘤中显示出高响应率,但感染风险增加. 在推的2期治疗方案中观察到持久的反应.
科学领域:
- 在瘤学瘤学.
- 免疫治疗是一种免疫疗法.
- 临床试验 临床试验
背景情况:
- 塔尔基塔马布和特克利斯塔马布分别是针对GPRC5D和BCMA的双特异抗体.
- 这两种抗体都通过向CD3来激活T细胞,用于多发性骨髓瘤治疗.
- 它们被批准用于三级暴露的复发性或耐火性多发性骨髓瘤.
研究的目的:
- 评估结合talquetamab和teclistamab的安全性和有效性.
- 为了确定这种组合治疗的推的2期治疗方案.
- 评估复发性或耐药性多发性髓瘤患者的不良事件,剂量限制性毒性和反应率.
主要方法:
- 在患有复发或耐火性多发性骨髓瘤的患者中进行了一项1b-2期研究.
- 第1阶段涉及五个剂量级的剂量升级.
- 确定了推的第二阶段治疗方案 (talquetamab 0.8 mg/kg + teclistamab 3.0 mg/kg每隔一周).
主要成果:
- 94名患者接受治疗;44名患者接受了推的第二阶段治疗方案.
- 观察到高响应率:80%的推疗法和78%的整体.
- 观察到持久的反应,在接受推疗法的86%的患者中,在18个月后仍然有反应.
- 常见的不良事件包括细胞因子释放综合征和中性;96%经历了3/4级的不良事件,64%有3/4级的感染.
结论:
- 塔尔基塔马布加上特克利斯塔马布在复发性/耐药性多发性髓瘤中显示出高响应率和持久响应.
- 与单一治疗相比,组合治疗导致3级或4级感染的发病率更高.
- 推的第二阶段治疗方案显示出有希望的疗效,可控毒性.
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