CTIS2023-506654-20-00招募中1 期
A Phase 1/2, multi-center, Open-label, Dose-finding Study to evaluate the safety, tolerability,pharmacokinetics, and pharmacodynamics of BMS-986458, alone and in combination with antilymphomaagents in Subjects with Relapsed/Refractory non-Hodgkin lymphomas (R/R NHL) - CA123-1000
Bristol-Myers Squibb Services Unlimited Company0 个研究点目标入组 241 人开始时间: 2023年10月17日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 241
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
- •Participants = 18 years of age with R/R NHL (including DLBCL [ie, DLBCL not otherwise specified (NOS) and diffuse large B-Cell lymphoma/high-grade B-Cell lymphoma with MYC and BCL2 rearrangements], and FL):, For R/R DLBCL (de novo) and FL 3b: following at least 2 prior lines of therapy (eg, first-line combination chemotherapy regimen containing rituximab, anthracycline, an alkylating agent, and steroids and at least one additional treatment)., For R/R DLBCL (transformed lymphoma): following at least 2 prior lines of therapy which must have been administered after transformation., For R/R FL (except for FL 3b): following at least 2 prior lines of therapy and meeting treatment criteria at the time of enrollment based on investigator´s assessment., Participant must have measurable disease (defined by at least one FDG-avid lesion for FDG-avid disease and one bi-dimensionally measurable disease on cross sectional imaging by computed tomography or magnetic resonance imaging with at least one lesion > 1.5 cm in the transverse diameter) and must accept and follow pregnancy prevention plan.
排除标准
- •Eastern Cooperative Oncology Group (ECOG) performance status = 2, Inability to comply with listed restrictions, precautions and prohibited treatments, Prior CAR-T, Cereblon-modulating drug or radiotherapy = 4 weeks, systemic anticancer treatment = 5 half-lives or 4 weeks, allogeneic SCT = 6 months or autologous SCT = 3 months prior to study intervention initiation, Any condition, including significant acute or chronic medical illness, active or uncontrolled infection, or the presence of laboratory abnormalities, that places participants at unacceptable risk if participating in this study; known or suspected central nervous system involvement.
研究者
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