2024-511747-25-00招募中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
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 225
- 试验地点
- 38
- 主要终点
- The primary endpoint of the study for each of the 5 disease-specific cohorts is as follows: ORR according to the Lugano Classification of response in malignant lymphoma (Cheson, 2014) and as assessed by independent central review.
研究概览
简要总结
To assess the anti-tumor activity of single agent Odronextamab as measured by the objective response rate (ORR) according to the Lugano Classification of response in malignant lymphoma and as assessed by independent central review in each of the following B-cell non-Hodgkin lymphoma (B-NHL) subgroups:
-
In patients with follicular lymphoma (FL) grade 1-3a that has relapsed after or is refractory to at least 2 prior lines of systemic therapy including an anti-CD20 antibody and an alkylating agent
-
In patients with diffuse large B-cell lymphoma (DLBCL) that has relapsed after or is refractory to at least 2 prior lines of systemic therapy including an anti-CD20 antibody and an alkylating agent
-
In patients with mantle cell lymphoma (MCL) who have relapsed or refractory disease to at least one prior line of systemic therapy and had prior Bruton’s tyrosine kinase (BTK) inhibitor treatment.
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In patients with marginal zone lymphoma (MZL) that has relapsed after or is refractory to at least 2 prior lines of systemic therapy
-
In patients with other B-NHL subtypes that has relapsed after or is refractory to at least 2 prior lines of systemic therapy
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
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
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •Other protocol-defined inclusion criteria apply
- •Adequate bone marrow, hepatic, and renal function as defined in the protocol
- •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 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.
- •Patients should in the judgment of the investigator require systemic therapy for lymphoma at the time of study enrollment
- •Measurable disease on cross sectional imaging as defined in the protocol documented by diagnostic imaging (computed tomography (CT), or magnetic resonance imaging (MRI)
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).
- •Prior treatment with an anti-CD20 x anti-CD3 bispecific therapy
- •Other protocol-defined exclusion criteria apply
- •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
- •Criterion removed
- •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
结局指标
主要结局
The primary endpoint of the study for each of the 5 disease-specific cohorts is as follows: ORR according to the Lugano Classification of response in malignant lymphoma (Cheson, 2014) and as assessed by independent central review.
The primary endpoint of the study for each of the 5 disease-specific cohorts is as follows: ORR according to the Lugano Classification of response in malignant lymphoma (Cheson, 2014) and as assessed by independent central review.
次要结局
- ORR according to the Lugano Classification and as assessed by local investigator evaluation
- Complete response (CR) rate according to the Lugano Classification and as assessed by local investigator evaluation and independent central review.
- Progression free survival (PFS) according to the Lugano Classification and as assessed by independent central review and local investigator evaluation
- Overall survival (OS)
- Duration of response (DOR) according to the Lugano Classification and as assessed by independent central review and local investigator evaluation
- Disease control rate (DCR) according to the Lugano Classification and as assessed by independent central review and local investigator evaluation by independent central review and local investigator evaluation
- Incidence and severity of treatment emergent adverse events (TEAEs)
- Pharmacokinetics: concentration of odronextamab, incidence of anti-drug antibodies (ADA) to odronextamab over time, incidence of neutralizing antibodies (Nab) to odronextamab over time
- Changes in scores of patient-reported outcomes as measured by EORTC QLQ-C30
- Changes in scores of patient-reported outcomes as measured by FACT-Lym
- Changes in scores of patient-reported outcomes as measured by EQ-5D-3L
研究者
Head EU Regulatory Affairs
Scientific
Regeneron Pharmaceuticals Inc.
研究点 (38)
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