Real-World Efficacy and Safety of Glofitamab-Based Salvage Therapy in Chinese Patients With Relapsed or Refractory...

Glofitamab, a CD20 × CD3 bispecific antibody, has demonstrated significant efficacy in relapsed or refractory (R/R) B-cell lymphomas. However, real-world evidence on its clinical performance and immunologic correlates, particularly in the context of chimeric antigen receptor T-cell (CAR-T) therapy, remains limited. This observational study included 64 patients with R/R aggressive B-cell lymphoma who received glofitamab-based therapy between February 2024 and December 2025 at the First Affiliated Hospital of Soochow University. The primary endpoint was complete response (CR) rate, whereas secondary endpoints included overall response rate (ORR), progression-free survival (PFS), overall survival (OS), and safety. We also analyzed the impact of prior bispecific antibody (BsAb) exposure on CAR-T cell manufacturing and efficacy and assessed the relationship between peripheral T-cell subsets and treatment outcomes. Among 56 evaluable patients, the CR and ORR were 41.1% and 78.7%, respectively. Median PFS and OS were not reached, with estimated 1-year PFS and OS rates of 61.3% and 67.7%. Patients with non-germinal center B-cell (non-GCB) subtype had significantly higher PFS than those with GCB subtype (p = 0.029), whereas prior CAR-T therapy was associated with poorer PFS (p = 0.022). Prior BsAb exposure did not affect CAR-T manufacture or efficacy. Immunophenotyping revealed that patients achieving CR had higher baseline CD4⁺ effector T-cell counts (p = 0.04) and higher early CD8⁺ T-cell expansion (p = 0.02). Overall, glofitamab demonstrated durable efficacy and a manageable safety profile in R/R aggressive B-cell lymphoma, with treatment outcomes closely associated with T-cell functional status, supporting its potential as an effective bridging strategy before CAR-T therapy.