A Phase II study evaluating efficacy of KTE-X19 CAR-T cell therapy in Relapsed or Refractory Mantle-Cell Lymphoma achieving a partial response during Ibrutinib salvage therapy

Survival in patients with relapsed/refractory mantle cell lymphoma (MCL) has significantly improved over the past decade, particularly due to the introduction of Ibrutinib. 
However, the prognosis for patients who achieve a partial response (PR) with Ibrutinib remains unsatisfactory. Although patients who attain a PR during Ibrutinib treatment at first relapse tend to have relatively good survival rates, the reality is that almost all of these patients will experience disease progression within the following months and will require additional treatment. 
The prognosis for patients who progress while on Ibrutinib is poor, with a life expectancy of less than one year. In recent years, however, the emergence of chimeric antigen receptor (CAR) T-cell therapy has begun to change this outlook. The product Brexucabtagene Autoleucel (KTE-X19) has been approved by both U.S. and European regulatory agencies for the treatment of R/R MCL patients after at least two prior lines of therapy, including a BTK inhibitor. 
Data reported in patients with chronic lymphocytic leukemia have shown that CAR-T cell therapy may be an effective strategy following Ibrutinib failure. Several preclinical studies have demonstrated that Ibrutinib treatment may enhance the anti-tumor activity of CAR-T cells. 
Therefore, the manufacturing and subsequent infusion of CAR-T cells in MCL patients who achieve only a PR during Ibrutinib therapy could represent a promising strategy to enhance CAR-T cell efficacy and achieve complete response in the majority of patients.