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

July 6, 2026 updated by: 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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China
        • Henan Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Biological: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best Overall Response Rate (ORR)
Time Frame: 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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease Control Rate (DCR)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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)
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yanyan Liu

Investigators

  • Principal Investigator: Yanyan Liu, Henan Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

July 6, 2026

First Submitted That Met QC Criteria

July 6, 2026

First Posted (Actual)

July 10, 2026

Study Record Updates

Last Update Posted (Actual)

July 10, 2026

Last Update Submitted That Met QC Criteria

July 6, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HNSZLYYNHL12
  • 2026-254 (Other Identifier: Henan Cancer Hospital Medical Ethics Committee)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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