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

NCT07695896 | Not Yet Recruiting

• 2 other identifiers: HNSZLYYNHL122026-254
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

Keywords

B-cell non-Hodgkin lymphoma; Bispecific antibody; Glofitamab; CD20xCD3; Real-world study; Relapsed refractory

Outcome Measures

Primary Outcomes (1)

• Best Overall Response Rate (ORR)

  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 Outcomes (7)

• Disease Control Rate (DCR)

  From treatment initiation until disease progression, assessed up to approximately 2 years

• Duration of Response (DOR)

  From first response until disease progression or death, assessed up to approximately 2 years

• Time to Next Treatment (TTNT)

  From treatment initiation until start of next therapy or death, assessed up to approximately 2 years

• Progression-Free Survival (PFS)

  From treatment initiation until disease progression or death, assessed up to approximately 2 years

• Overall Survival (OS)

  From treatment initiation until death from any cause, assessed up to approximately 2 years

Study Arms (1)

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

Interventions

Glofitamab BIOLOGICAL

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.

R/R B-NHL treated with bispecific antibody

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yanyan Liu: lead

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Henan, China

Location

MeSH Terms

Conditions

Recurrence; Lymphoma, B-Cell

Interventions

glofitamab

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Yanyan Liu

  Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yanyan Liu

CONTACT

+86 13838176375; yyliu@zzu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 6, 2026
• First Posted: July 10, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 10, 2026

Record last verified: 2026-07

Locations

CN (1)