jRCT2031260191尚未招募不适用
A Phase 1/2 Open-label, Multi-center Study to Evaluate the Safety and Clinical Activity of GSK5926371 in Adult Participants with Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (B NHL)
未提供0 个研究点目标入组 49 人开始时间: 待定
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 49
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Participants >18 years of age
- •Has histologically confirmed Relapsed/Refractory (R/R) B-NHL, for which systemic treatment is indicated,
- •a) Has measurable disease,
- •b) Has received at least 2 prior lines of systemic anti-neoplastic therapy, including an anti-CD20-containing combination appropriate for the indication;
- •c) Has documented disease relapse, progression or disease refractory to the most recent line of therapy, per Lugano criteria.:
- •Willing to use adequate contraception (Participant of childbearing potential [POCBP] only).
- •Is capable of giving signed informed consent
- •Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to
- •Has adequate organ function.
排除标准
- •Has a malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas (e.g., breast, cervix, bladder) that have been resected with no evidence of metastatic disease.
- •Has had any major surgery within 4 weeks prior to the first dose of GSK5926371 or has not recovered from prior surgeries or complications.
- •Has a history of Progressive multifocal leukoencephalopathy (PML), current central nervous system (CNS) involvement by lymphoma, or a history of significant CNS disease such as uncontrolled seizures, stroke, epilepsy, CNS vasculitis, and neurodegenerative conditions.
- •Has an active uncontrolled infection.
- •Has received a prior Allogeneic stem cell transplant (allo-SCT) within 12 months prior to the first dose of GSK5926371 or has active graft-versus-host disease requiring systemic immunosuppressive therapy.
- •Has received a prior autologous stem cell transplant within 100 days prior to the first dose of GSK
- •Has received prior treatment with Chimeric antigen receptor T-cell (CAR-T) therapy within 12 weeks of first GSK5926371 administration.
- •Has received prior treatment with CD19- or CD20-targeting Bispecific antibody (BsAbs) within 8 weeks of the first dose of study intervention.
- •Has QT interval corrected (QTc) >450 milliseconds (msec) or QTc >480 msec for participants with bundle branch block.
- •Has significant cardiovascular disease such as uncontrolled arrhythmias, Class 3 or 4 congestive heart failure as defined by the New York Heart Association Functional Classification, ejection fraction <- 45% by any methods in the 12 months of enrollment, unstable angina or acute coronary syndrome including myocardial infarction within 6 months of enrollment.
研究者
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