Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Glofitamab | Biological | Glofitamab | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- R/R B-NHL treated with bispecific antibody
- description
- 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.
- interventionNames
- Biological: Glofitamab
Primary outcomes (1)
- measure
- Best Overall Response Rate (ORR)
- timeFrame
- From treatment initiation until disease progression or start of new anti-lymphoma therapy, assessed up to approximately 2 years
- description
- 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.
Secondary outcomes (7)
- measure
- Disease Control Rate (DCR)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available