NCT03888105进行中（未招募）2 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
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 515
- 试验地点
- 119
- 主要终点
- Objective Response Rate (ORR), as assessed by independent central review
研究概览
简要总结
This study is researching an investigational drug, odronextamab, in adult patients B-cell non-Hodgkin's lymphoma (B-NHL).
The main purpose of this study is to assess the effectiveness of odronextamab in destroying cancer cells and to learn more about the safety of odronextamab.
The study is looking at several other research questions, including:
- To see if odronextamab works to destroy cancer cells
- Side effects that may be experienced by people taking odronextamab
- How odronextamab works in the body
- How much odronextamab is present in the blood
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •Patients should in the judgment of the investigator require systemic therapy for lymphoma at the time of study enrollment
- •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: Patients with MCL who have relapsed or refractory disease to at least one prior line of systemic therapy and had prior treatment with a Bruton's tyrosine kinase (BTK) inhibitor
- •MZL cohort: Patients with MZL that have relapsed or is refractory to at least 2 prior lines of systemic therapy
- •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. New enrollment stopped for patients with Burkitt lymphoma and Burkitt-like lymphoma.
- •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
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, up to 12 months prior to first administration of study drug. The presence of acute or chronic graft-versus host disease (GVHD) will also be an exclusion
- •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 of 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; cytomegalovirus (CMV) infection as noted by detectable levels on a blood polymerase chain reaction (PCR) assay as defined in the protocol or other uncontrolled infections
- •Known hypersensitivity to both allopurinol and rasburicase
- •Prior treatment with an anti-CD20 x anti-CD3 bispecific therapy
- •Note: Other protocol-defined Inclusion/Exclusion criteria apply
研究组 & 干预措施
FL
Experimental
Follicular lymphoma grade 1-3a cohort
干预措施: Odronextamab (Drug)
DLBCL
Experimental
Diffuse large B-cell lymphoma cohort
干预措施: Odronextamab (Drug)
MZL
Experimental
Marginal Zone Lymphoma cohort
干预措施: Odronextamab (Drug)
MCL
Experimental
Mantle Cell Lymphoma cohort
干预措施: Odronextamab (Drug)
Other B-NHL
Experimental
Other B-cell non-Hodgkin lymphoma cohort (excluding FL Grade 1-3a, DLBCL, MCL, MZL, Waldenström macroglobulinemia [WM]); Patients with a current diagnosis of mixed histology of B-NHL with an aggressive component (such as concurrent FL and DLBCL) will be allowed
干预措施: Odronextamab (Drug)
结局指标
主要结局
Objective Response Rate (ORR), as assessed by independent central review
时间窗: Up to 52 weeks of study treatment
FL grade 1-3a/MZL
ORR, as assessed by independent central review
时间窗: Up to 36 weeks of study treatment
DLBCL/MCL/Other B-NHL
次要结局
- Incidence of Neutralizing antibodies (Nab) to odronextamab over time(12 weeks following end of treatment)
- Changes in scores of patient-reported outcomes as measured by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Cancer-30 (EORTC-QLQ-C30)(Approximately 194 weeks following the first dose)
- Changes in scores of patient-reported outcomes as measured by Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym)(Approximately 194 weeks following the first dose)
- ORR, as assessed by the local investigator(Up to 52 weeks of study treatment)
- CR rate, as assessed by independent central review(Up to 52 weeks of study treatment)
- DCR, as assessed by the local investigator(Up to 52 weeks of study treatment)
- ORR, as assessed by the local investigator(Up to 36 weeks of study treatment)
- Complete Response (CR) Rate, as assessed by the local investigator(Up to 52 weeks of study treatment)
- CR rate, as assessed by independent central review(Up to 36 weeks of study treatment)
- CR rate, as assessed by the local investigator(Up to 36 weeks of study treatment)
- Progression-Free Survival (PFS), as assessed by independent central review(Approximately 194 weeks following the first dose)
- PFS, as assessed by the local investigator(Approximately 194 weeks following the first dose)
- Overall Survival (OS)(Approximately 194 weeks following the first dose)
- Duration Of Response (DOR), as assessed by independent central review(Approximately 194 weeks following the first dose)
- DOR, as assessed by the local investigator(Approximately 194 weeks following the first dose)
- Disease Control Rate (DCR), as assessed by independent central review(Up to 52 weeks of study treatment)
- DCR, as assessed by the local investigator(Up to 36 weeks of study treatment)
- DCR, as assessed by independent central review(Up to 36 weeks of study treatment)
- Incidence and severity of Treatment Emergent Adverse Events (TEAEs)(Approximately 194 weeks following the first dose)
- Concentration of odronextamab(12 weeks following end of treatment)
- Incidence of Anti-Drug Antibodies (ADA) to odronextamab over time(12 weeks following end of treatment)
- Titer of anti-drug antibodies to odronextamab over time(12 weeks following end of treatment)
- Changes in scores of patient-reported outcomes as measured by EuroQol-5 Dimensions-3 Levels (EQ-5D-3L)(Approximately 194 weeks following the first dose)
研究者
研究点 (119)
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