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Real-World Study of Bispecific Antibody in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

2026年7月6日 更新者：Yanyan Liu

A Real-World Study on the Efficacy and Safety of Bispecific Antibody in the Treatment of Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

B-cell non-Hodgkin lymphoma (B-NHL) is the most common type of lymphoma. Although first-line R-CHOP can cure a proportion of patients, approximately 30%-40% relapse or become refractory (R/R). CD20xCD3 bispecific antibodies, represented by glofitamab, have shown significant efficacy in clinical trials. However, large-scale real-world efficacy and safety data in Chinese clinical practice are still lacking, particularly regarding combination with different regimens and use in the relapsed population.

This is a prospective, multicenter, observational registry study evaluating the efficacy and safety of CD20xCD3 bispecific antibody-containing regimens in patients with relapsed or refractory B-cell non-Hodgkin lymphoma in a real-world setting. Efficacy is assessed using the Lugano 2014 response criteria. The primary endpoint is best objective response rate (ORR).

研究概览

地位

尚未招聘

条件

干预/治疗

详细说明

Study design: Prospective, multicenter, observational (non-interventional) registry study.

Population: Patients aged >=18 years with histologically confirmed B-cell non-Hodgkin lymphoma who are relapsed or refractory after at least one prior line of therapy and who receive a CD20xCD3 bispecific antibody-containing regimen after study initiation.

Efficacy evaluation: Lugano 2014 response criteria.

Primary endpoint: Best objective response rate (ORR).

Secondary endpoints: Complete response rate (CRR), disease control rate (DCR), duration of response (DOR), time to next treatment (TTNT), progression-free survival (PFS), overall survival (OS), and safety.

Exploratory endpoints: Subgroup analyses by combination pattern (e.g., combined with chemotherapy or targeted agents) and special populations; correlation of biomarkers (e.g., peripheral blood lymphocyte subsets, T-lymphocyte mitochondrial immune analysis, cytokines) with efficacy and safety; and patient compliance and quality-of-life analyses based on electronic patient-reported outcomes (ePRO).

Planned enrollment: 200 participants. As a non-interventional study, no formal statistical hypothesis is tested; the sample size is based on the confidence-interval width method (expected ORR P=0.5, half-width d=0.07), yielding approximately 196 participants, rounded to 200.

研究类型

观察性的

注册 (估计的)

200

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
    • Henan
      • Zhengzhou、Henan、中国
        • Henan Cancer Hospital
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Patients with relapsed or refractory B-cell non-Hodgkin lymphoma who receive a CD20xCD3 bispecific antibody-containing regimen (e.g., glofitamab) in routine clinical practice at participating hospitals in China.

描述

Inclusion Criteria:

  • Age >= 18 years at the start of treatment
  • Histologically confirmed B-cell non-Hodgkin lymphoma
  • Relapsed or refractory disease after at least one prior line of systemic therapy
  • Planned to receive a CD20xCD3 bispecific antibody-containing regimen after study initiation
  • Signed informed consent for the investigational treatment

Exclusion Criteria:

  • Currently participating in, or planning to participate in, any interventional clinical trial
  • Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
R/R B-NHL treated with bispecific antibody
Patients with relapsed or refractory B-cell non-Hodgkin lymphoma who receive a CD20xCD3 bispecific antibody-containing regimen (e.g., glofitamab) in routine clinical practice. This is a single observational cohort; no treatment is assigned by the study.
生物：Glofitamab
Glofitamab, a CD20xCD3 bispecific monoclonal antibody, administered per real-world clinical practice and product labeling. As an observational study, treatment is determined by the treating physician and not by the study protocol; the intervention of interest is recorded to describe the treated population.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Best Overall Response Rate (ORR)
大体时间：From treatment initiation until disease progression or start of new anti-lymphoma therapy, assessed up to approximately 2 years
ORR is defined as the proportion of participants achieving a best overall response of complete response (CR) or partial response (PR), assessed by the investigator according to the Lugano 2014 response criteria for malignant lymphoma.
From treatment initiation until disease progression or start of new anti-lymphoma therapy, assessed up to approximately 2 years

次要结果测量

结果测量
措施说明
大体时间
Disease Control Rate (DCR)
大体时间：From treatment initiation until disease progression, assessed up to approximately 2 years
DCR is defined as the proportion of participants achieving complete response (CR), partial response (PR), or stable disease (SD) per Lugano 2014 criteria.
From treatment initiation until disease progression, assessed up to approximately 2 years
Duration of Response (DOR)
大体时间：From first response until disease progression or death, assessed up to approximately 2 years
DOR is defined as the time from the first documented CR or PR to the first documented disease progression or death from any cause, whichever occurs first, among responders.
From first response until disease progression or death, assessed up to approximately 2 years
Time to Next Treatment (TTNT)
大体时间：From treatment initiation until start of next therapy or death, assessed up to approximately 2 years
TTNT is defined as the time from treatment initiation to the start of the next line of anti-lymphoma therapy or death from any cause, whichever occurs first.
From treatment initiation until start of next therapy or death, assessed up to approximately 2 years
Progression-Free Survival (PFS)
大体时间：From treatment initiation until disease progression or death, assessed up to approximately 2 years
PFS is defined as the time from treatment initiation to the first documented disease progression per Lugano 2014 criteria or death from any cause, whichever occurs first.
From treatment initiation until disease progression or death, assessed up to approximately 2 years
Overall Survival (OS)
大体时间：From treatment initiation until death from any cause, assessed up to approximately 2 years
OS is defined as the time from treatment initiation to death from any cause.
From treatment initiation until death from any cause, assessed up to approximately 2 years
Incidence of Adverse Events (Safety)
大体时间：From treatment initiation until 90 days after last dose, assessed up to approximately 2 years
Safety is assessed by the incidence, severity, and type of adverse events (AEs) and serious adverse events (SAEs), including adverse events of special interest such as cytokine release syndrome (CRS), graded per NCI CTCAE and, for CRS, per ASTCT consensus criteria.
From treatment initiation until 90 days after last dose, assessed up to approximately 2 years
Complete Response Rate (CRR)
大体时间：From treatment initiation until disease progression or start of new therapy, assessed up to approximately 2 years
CRR is defined as the proportion of participants achieving a best overall response of complete response (CR) per Lugano 2014 criteria.
From treatment initiation until disease progression or start of new therapy, assessed up to approximately 2 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Yanyan Liu

调查人员

  • 首席研究员：Yanyan Liu、Henan Cancer Hospital

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年7月1日

初级完成 (估计的)

2028年12月1日

研究完成 (估计的)

2028年12月1日

研究注册日期

首次提交

2026年7月6日

首先提交符合 QC 标准的

2026年7月6日

首次发布 (实际的)

2026年7月10日

研究记录更新

最后更新发布 (实际的)

2026年7月10日

上次提交的符合 QC 标准的更新

2026年7月6日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • HNSZLYYNHL12
  • 2026-254 (其他标识符：Henan Cancer Hospital Medical Ethics Committee)

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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