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 monoclonal antibody, in Patients with B-cell Malignancies

Regeneron Pharmaceuticals, Inc0 个研究点目标入组 172 人开始时间: 2015年6月30日最近更新: 2024年1月15日

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 172

研究概览入排标准研究者记录与标识符相似试验

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

•1-Principal Inclusion Criteria for B-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, and for whom treatment with an anti-CD20 antibody may be appropriate:
•i. B-NHL per WHO 2008 criteria (Campo 2011)
•b. Documented HL, per WHO 2008 criteria (Campo 2011), with active disease not responsive to prior therapy or relapsed after prior therapy for whom no standard of care options exist (cemiplimab single agent therapy cohorts ONLY)
•All patients must have at least one bi-dimensionally measurable lesion (=1.5 cm) documented by diagnostic imaging (CT, PET-CT, or MRI).
•Eastern Cooperative Oncology Group (ECOG) performance status =1. Note: Individual cases of patients with ECOG 2 performance status may be discussed with the medical monitor for potential enrollment.
•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)
•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 86
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 86

排除标准

•1-Principal Exclusion Criteria for B-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, which may suggest risk for iAEs
•History of treatment-related iAEs from immune-modulatory agents
•Standard or investigational anti-neoplastic therapy (nonbiologic) within 5-times the half life or within 28 days, whichever is shorter, prior to first administration of study drug
•Standard radiotherapy within 14 days of first administration of study drug
•Treatment with alemtuzumab within 12 weeks prior to first administration of study drug(s)
•Treatment with rituximab, immune-modulating agents or other investigational or commercial biologic agent less than 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)
•Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection; or other uncontrolled infection.

研究者

发起方

Regeneron Pharmaceuticals, Inc

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