CTIS2023-505865-94-00招募中1 期
A Phase I/II, Open-Label, Multi-Cohort Study to Evaluate the Efficacy and Safety of Cevostamab in Prior B Cell Maturation Antigen-Exposed Patients With Relapsed/Refractory Multiple Myeloma - CO43476
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 92
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Documented diagnosis of multiple myeloma (MM) based on standard International Myeloma Working Group (IMWG) criteria, Evidence of progressive disease based on investigators determination of response by IMWG criteria on or after their last dosing regimen, Prior B cell maturation antigen (BCMA) antibody-drug conjugate (ADC) or chimeric antigen receptor T (CAR-T) Cohort: participants who have received a BCMA-targeted CAR-T or ADC therapy and are triple-class relapsed or refractory, Prior BCMA Bispecific Cohort: participants who have received a BCMA-targeting T-cell-dependent bispecific (TDB) antibody and are triple-class relapsed or refractory, Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1, Life expectancy is at least 12 weeks
排除标准
- •Inability to comply with protocol-mandated hospitalization, Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 5 months after the final dose of cevostamab or within 3 months after the last dose of tocilizumab, Prior treatment with cevostamab or another agent with the same target, Prior BCMA ADC or CAR-T Cohort: prior treatment with any T cell dependent bi-specific antibody (TDB) antibody including non BCMA targeting TDB, Prior BCMA Bispecific Cohort: treatment with TDB antibody within 12 weeks prior to enrollment in the study, Prior use of any monoclonal antibody (mAb), radioimmunoconjugate, or ADC as anti-cancer therapy within 4 weeks before first study treatment, except for the use of non-myeloma therapy
研究者
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