EUCTR2017-002139-41-GB进行中（未招募）1 期
An Open-Label Study to Assess the Anti-Tumor Activity and Safety of REGN1979, an anti CD20 x anti-CD3 Bispecific Antibody, in Patients with Relapsed or Refractory B-cell non-Hodgkin Lymphoma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 481
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •The enrolment of all patients with B-cell malignancies is paused as of protocol amendment EU4
- •For the FL grade 1-3a cohort only: Central histopathologic confirmation of the FL Grade 1 to 3a diagnosis must be obtained before study enrollment. Patients with FL grade 3b are ineligible for this cohort but may be included in the other B-NHL” cohort. Follicular lymphoma subtyping is based on the World Health Organization (WHO) classification (Swerdlow, 2017).
- •Disease-specific cohorts:
- •FL grade 1-3a cohort: Patients with FL grade 1-3a that has relapsed after or is refractory to at least 2 prior lines of systemic therapy as defined in the protocol.
- •DLBCL cohort: Patients with DLBCL that has relapsed after or is refractory to at least 2 prior lines of systemic therapy as defined in the protocol.
- •MCL after BTK inhibitor therapy cohort: Not currently enrolling patients with mantle cell lymphoma (MCL) as of Global Amendment 3
- •MZL cohort: Patients with MZL that has relapsed after or is refractory to at least 2 prior lines of systemic therapy as defined in the protocol.
- •Other B-NHL cohort: Patients with B-NHL other than FL grade 1-3a, DLBCL, MCL, or MZL that has relapsed after or is refractory to at least 2 prior lines of systemic therapy as defined in the protocol.
- •Patients should in the judgment of the investigator require systemic therapy for lymphoma at the time of study enrollment and deemed not appropriate for any other approved therapy with established benefit for that indication
- •Measurable disease on cross sectional imaging as defined in the protocol documented by diagnostic imaging (computed tomography (CT), or magnetic resonance imaging (MRI))
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •Adequate bone marrow, hepatic, and renal function as defined in the protocol
- •Note: Other protocol defined Inclusion criteria apply
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 193
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 288
排除标准
- •Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS Non-Hodgkin Lymphoma (NHL) (suspected CNS lymphoma should be evaluated by lumbar puncture, as appropriate, in addition to the mandatory head CT or MRI).
- •Treatment with any systemic anti-lymphoma therapy within 5 half-lives or within 28 days prior to first administration of study drug, whichever is shorter.
- •History of allogeneic stem cell transplantation
- •Prior treatment with any chimeric antigen receptor T-cell (CAR-T) therapy
- •Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone or anti-inflammatory equivalent within 72 hours of start of study drug
- •History of neurodegenerative condition or CNS movement disorder. Patients with a history seizure within 12 months prior to study enrollment are excluded.
- •Another malignancy except B-NHL in the past 5 years, with the exception of non-melanoma skin cancer that has undergone potentially curative therapy or in situ cervical carcinoma, or any other tumor that has been deemed to be effectively treated with definitive local control and with curative intent.
- •Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection; or other uncontrolled infection as defined in the protocol
- •Known hypersensitivity to both allopurinol and rasburicase
- •Prior treatment with an anti-CD20 x anti-CD3 bispecific therapy
- •Note: Other protocol defined Exclusion criteria apply
研究者
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