drugset / Trial / NCT06552572

Glofitamab in Relapsed or Refractory Diffuse Large B-cell Lymphoma After CD19 Chimeric Antigen Receptor T-cell Therapy

NCT06552572

Phase 2 Active not recruiting 30 enrolled Samsung Medical Center
NaSingle-groupOpen-labelTreatment

Summary

The objective of this clinical trial is to determine whether the CD20-CD3 bispecific antibody, glofitamab, is effective in treating residual diffuse large B-cell lymphoma (DLBCL) in adults who have responded to CD19 Chimeric antigen receptor (CAR) T-cell therapy for their relapsed or refractory DLBCL. Additionally, the trial will assess the safety of glofitamab in patients undergoing CD19 CAR T-cell therapy. The primary questions to be addressed are: Does glofitamab reduce the number of participants experiencing disease progression following CD19 CAR T-cell therapy? What are the medical complications in participants already treated with CD19 CAR T-cell therapy when administered glofitamab? Participants are required to: Receive glofitamab every 21 days for 12 cycles or until disease progression. Attend the clinic for checkups and tests every three weeks.

Timeline

Start
2024-11-26
Primary completion
2026-06-30
Completion
2028-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Glofitamab Monoclonal antibody 30 mg Intravenous