JPRN-jRCT2031210238招募中1 期
A phase Ib, multi-center, open-label dose escalation and expansion platform study of VAY736 as single agent and in combination with select antineoplastic agents in patients with non-Hodgkin Lymphoma (NHL)
Suzuki Kazuyuki0 个研究点目标入组 86 人开始时间: 2021年8月13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
- 86
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Adult patients with histologically confirmed diagnosis of B-cell NHL with all subtypes per WHO 2016 criteria. Patients in subtype arms e.g. diffuse large B-cell lymphoma (DLBCL) must have confirmed diagnosis of r/r DLBCL.
- •- Received and failed or be intolerant to standard of care therapy (at least two prior lines, including an anti-CD20 therapy, but no more than 5 prior lines) .
- •- Must have measurable disease and ECOG =< 2
- •- Must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy and must be willing to undergo study required biopsies at screening and during therapy.
排除标准
- •- Baseline laboratory results outside of protocol defined ranges.
- •- Presence or history of central nervous system involvement by lymphoma
- •- Ongoing immunosuppressive therapy for treatment of lymphoma
- •- History of hypersensitivity to VAY736 or any of its excipients or to drugs in similar chemical classes (e.g. mAb)
- •- Impaired cardiac function or clinically significant cardiac disease
- •- History of or current interstitial lung disease or pneumonitis >= Grade 2
- •- Human immunodeficiency virus (HIV) infection
- •- Active hepatitis C infection and/or hepatitis B infection
- •- Pregnant or nursing (lactating) women, women of child-bearing potential unless they are using highly effective methods of contraception
研究者
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