CTIS2022-500687-35-00招募中1 期
A Single-Arm, Open-Label, Multicenter Phase 1/2 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Bcl 2 Inhibitor BGB-11417 in Patients With Relapsed or Refractory Mantle Cell Lymphoma - BGB-11417-201
Beigene Ltd.0 个研究点目标入组 130 人开始时间: 2022年9月12日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 130
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
- •Histologically confirmed diagnosis of MCL, Prior systemic treatments for MCL (at least one line of anti-cluster of differentiate 20 (CD20) based immune or chemoimmunotherapy and at least one line of treatment with covalent or non-covalent Bruton Tyrosine Kinase Inhibitor (BTKi) as mono- or combination therapy), relapsed/refractory disease, Presence of measurable disease, Availability of archival tissue confirming diagnosis of MCL, or willing to undergo fresh tumor biopsy, Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2, Adequate organ function
排除标准
- •Known central nervous system involvement by lymphoma, Prior malignancy other than MCL within the past 3 years, except for curatively treated basal or squamous cell skin cancer, superficial bladder cancer, carcinoma in situ of the cervix or breast, or localized Gleason score 6 prostate cancer., Prior exposure to a Bcl-2 inhibitor (eg, venetoclax/ABT-199)., Prior autologous stem cell transplant within the last 3 months; or prior chimeric cell therapy within the last 3 months; or prior allogeneic stem cell transplant within the last 6 months or currently has an active graft-vs-host disease requiring the use of immunosuppressants., Clinically significant cardiovascular disease., Major surgery or significant injury = 4 weeks prior to start of study treatment., Active fungal, bacterial or viral infection requiring systemic treatment.
研究者
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