Multicenter phase 1-2 of CD19 CAR T-cell therapy (GLPG5101) for relapsed or refractory B-cell NHL: phase 1 results from ATALANTA-1

CAR T-cell therapies have transformed the treatment of B-cell non-Hodgkin lymphoma (B-NHL), but centralised manufacturing drives up costs and restricts access. The phase1-2 ATALANTA-1 trial, at 5 centers in The Netherlands and Belgium, evaluated the fresh CD19 CAR T-cell product GLPG5101, manufactured through a decentralized process, for relapsed or refractory B-NHL. Phase 1 results have now been published. The trial included adult patients after two or more lines of therapy, with an ECOG performance status 0-2 and adequate organ function. After leukapheresis and lymphodepleting chemotherapy, patients were treated with a single intravenous infusion of GLPG5101 at one of three dose levels. Among 23 patients (median age 66.5 years; IQR 59.0-71.5), median follow-up was 24.0 months (IQR 20.7-24.9). All patients had grade 3 or higher treatment-emergent adverse events; treament-related deaths occurred in four patients. The safety review committee selected 110 x 10⁶ (range 50-110 x 10⁶) viable CAR T-cells as the recommended phase 2 dose. The authors conclude that the results of this study showed the feasibility of rapid multicenter decentralized manufacturing and delivery of fresh CAR T-cell therapy in heavily pretreated B-NHL.