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

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 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.

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