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NCT07695896

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

Sponsor: Yanyan Liu

View on ClinicalTrials.gov

Summary

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).

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2026-07

Completion Date

2028-12

Last Updated

2026-07-10

Healthy Volunteers

No

Interventions

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.

Locations (1)

Henan Cancer Hospital

Zhengzhou, Henan, China