EUCTR2017-002139-41-IT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 Follicular Lymphoma - NA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 112
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
- •Principal inclusion in the study are:
- •1.Age 18 years or greater
- •2.Central histopathologic confirmation of the FL Grade 1 to 3a diagnosis must be obtained before study enrollment. Patients with FL grade 3b are ineligible. Follicular lymphoma subtyping is based on the World Health Organization (WHO) classification (Swerdlow, 2017).
- •3.Must have received at least 2 prior lines of therapy, including an anti-CD20 antibody and an alkylating agent.
- •4.Measurable disease on cross sectional imaging (defined as at least 1 bi dimensionally measurable nodal lesion of =1.5 cm in the greatest transverse diameter (GTD) regardless of the short axis diameter) documented by diagnostic imaging (computed tomography [CT], or magnetic resonance imaging [MRI]).
- •5.Eastern Cooperative Oncology Group (ECOG) performance status 0 or1.
- •6.Adequate bone marrow function as documented by:
- •a.Platelet count =50 x 109/L. A patient may not have received platelet transfusion within 7 days prior to first dose of REGN1979 in order to meet the platelet eligibility criterion.
- •b.Hemoglobin =9.0 g/dL
- •c.Absolute neutrophil count (ANC) =1.0 x 109/L. A patient may not have received granulocyte colony stimulating factor within 2 days prior to first dose of REGN1979 in order to meet the ANC eligibility criterion.
- •7.Adequate hepatic function
- •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 44
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 68
排除标准
- •Principal exclusion criteria are:
- •1.Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS NHL (suspected CNS lymphoma should be evaluated by lumbar puncture, as appropriate, in addition to the mandatory head CT or MRI).
- •2.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.
- •3.History of allogeneic stem cell transplantation
- •4.Prior treatment with any chimeric antigen receptor T-cell (CAR-T) therapy
- •5.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
- •6.History of neurodegenerative condition or CNS movement disorder
- •7.Vaccination within 28 days prior to first study drug administration with a vector that has replicative potential
研究者
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