EUCTR2015-001697-17-ES进行中（未招募）1 期
A Phase 1 Study to Assess Safety and Tolerability of REGN1979, an anti-CD20 x anti- CD3 bispecific monoclonal antibody, and REGN2810, an anti-programmed death-1 (PD-1) monoclonal antibody, in Patients with B-cell Malignancies
Regeneron Pharmaceuticals, Inc0 个研究点目标入组 318 人开始时间: 2015年10月15日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 318
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 Criteria for B-cell NHL and HL Treatment Arms:
- •Hematologic malignancy defined by either:
- •a. NHL: Documented CD20+ B-cell malignancy, with active disease that is either refractory to or relapsed after most recent prior therapy, for whom no standard of care options exist, or for whom alternative available options are not considered appropriate and for whom treatment with an anti-CD20 antibody may be appropriate:
- •i. B-NHL confirmed by the Lugano Classification, 2014
- •b. Documented Hodgkin?s lymphoma (HL), with active disease not responsive to prior therapy or relapsed after prior therapy for whom no standard of care options exist or for whom alternative available options are not considered appropriate. (REGN2810 single-agent therapy cohorts ONLY)
- •All patients must have at least one bi-dimensionally measurable lesion (?1.5 cm) documented by diagnostic imaging (CT or MRI).
- •Age ?18 years
- •Adequate bone marrow function documented by:
- •a. Platelet counts ?75 x 109/L
- •b. Hb level ?9 g/dL
- •c. ANC ?1 x 109/L
- •Adequate hepatic function:
- •a. Total bilirubin ?1.5 x ULN (?3 x ULN if liver involvement)
- •b. Transaminases ?2.5 x ULN (?5 x ULN if liver involvement)
- •c. Alkaline phosphatase (ALP) ?2.5 x ULN (?5 x ULN if liver involvement)
- •Inclusion Criteria for Acute Lymphoblastic Leukemia Study Arms
- •A patient must meet the following criteria to be eligible for inclusion in the study:
- •Documented relapsed or refractory CD20+ B-precursor ALL (defined as CD20 expression by flow cytometry on ?20% of leukemic lymphoblasts) after induction and one cycle of consolidation chemotherapy
- •a. Patients with Philadelphia chromosome positive (Ph+) ALL are required to have failed or be intolerant to second generation TKI
- •Age ?18 years
- •Central Nervous System (CNS) negative disease, confirmed by LP, within 28 days of starting study drug.
- •Adequate bone marrow function documented by:
- •a. Platelet counts ?10 x 109/L
- •b. Hb level ?7 g/dL
- •c. Absolute phagocyte count (APC) ?0.5 x 109/L (phagocytes: neutrophils, bands and monocytes)
- •Adequate hepatic function:
- •a. Total bilirubin ?1.5 x ULN (?3 x ULN if liver involvement)
- •b. Transaminases ?2.5 x ULN (?5 x ULN if liver involvement)
- •c. Alkaline phosphatase (ALP) ?2.5 x ULN (?5 x ULN if liver involvement)
- •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 214
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 106
排除标准
- •Principal Exclusion Criteria for B-cell NHL and HL Treatment Arms
- •Primary central nervous system (CNS) lymphoma, or known or suspected CNS involvement by non-primary CNS NHL
- •History of or current relevant CNS pathology
- •Ongoing or recent (within 2 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments
- •Standard anti-lymphoma chemotherapy (non-biologic) or radiotherapy within 28 days prior to first administration of study drug(s)
- •Treatment with an investigational non-biologic agent within 28 days prior to first administration of study drug(s).
- •Treatment with rituximab, alemtuzumab, immune-modulating agents or other investigational or commercial biologic agent within 28 days prior to first administration of study drug(s).
- •Prior Allogeneic stem cell transplantation
- •Prior treatment with an agent that blocks the PD-1/PD-L1 pathway, unless the patient demonstrated benefit (applicable only for patients in single-agent REGN2810 therapy).
- •Principal Exclusion Criteria for Acute Lymphoblastic Leukemia Treatment Arms
- •History of or current relevant CNS pathology
- •Ongoing or recent (within 2 years) evidence of significant autoimmune disease (with the exception of GvHD) that required treatment with systemic immunosuppressive treatments
- •Standard anti-leukemia chemotherapy (non-biologic) or radiotherapy within 14 days prior to first administration of study drug(s)
- •Treatment with an investigational non-biologic agent within 14 days prior to first administration of study drug(s).
- •Treatment with rituximab, immune modulating agents or other investigational or commercial biologic agent within 14 days prior to first administration of study drug.
- •Treatment with alemtuzumab, within 12 weeks
- •Prior Allogeneic stem cell transplantation within 3 months of treatment
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