CD19 CAR-T Outcomes in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma: A Retrospective Cohort Study from the Calabria Referral Center in Southern Italy

Background: Chimeric antigen receptor (CAR) T-cell therapy has transformed the therapeutic landscape for relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). Our study aims to describe the clinical outcomes of CAR T-cell therapy in patients with R/R DLBCL treated at a single regional center in Italy, with the goal of comparing these outcomes to those reported by high-volume academic centers. Methods: Data were retrospectively collected from a cohort of consecutive 41 patients who underwent to CD19 CAR-T infusion from June 2020 until September 2024 at CAR-T center of Reggio Calabria (Italy). Results: The median age was 66 years, 60.9% were refractory to their most recent regimen, and 24.4% had previously failed autologous stem cell transplant. Bridging therapy was administered in 82.9% of cases. A total of 27 patients (65.8%) received Axi-cel, and 14 (34.2%) received Tisa-cel. At median follow-up of 6.9 months, the best ORR and CR rate were 63.4% and 51.2%, respectively. Median PFS was 3 months, and median OS was 8.4 months. A total of 81.4% of patients developed a CRS, grade 1 in most cases (78.4%); 26.8% developed ICANS: two (5.4%) and three (8.1%) had grade 2 and 3, respectively. In univariate analyses, early response predicted longer survival, whereas high tumor burden and more than one extranodal site were associated with worse outcomes. Conclusions: Our retrospective cohort study reports similar data in terms of clinical response as compared to pivotal trials and other reports, confirming that CAR-T may offer more durable response rates and longer progression-free intervals in R/R DLBCL in our real-world context.