<scp>Real‐world</scp> evidence of the safety and survival with <scp>CD19 CAR‐T</scp> cell therapy for relapsed/refractory solid organ <scp>transplant‐related PTLD</scp>
Marshall McKenna, Narendranath Epperla, Armin Ghobadi, Jieqi Liu, Aleksandr Lazaryan, Uroosa Ibrahim, Caron A. Jacobson, Seema Naik, Loretta J. Nastoupil, Sayan Mullick Chowdhury, Timothy Voorhees, Miriam T. Jacobs, Umar Farooq, Keren Osman, Adam J. Olszewski, Sairah Ahmed, Andrew M. Evens
Abstract
The use of CD19 chimeric antigen receptor T-cell (CAR-T) therapy for relapsed/refractory solid organ transplantation (SOT)-related post-transplant lymphoproliferative disorder (PTLD) is not well studied. We conducted a multicentre, retrospective analysis of adults with relapsed/refractory SOT-associated PTLD. Among 22 relapsed/refractory SOT-PTLD patients, the pathology was monomorphic B cell. Prior SOTs included 14 kidney (64%), three liver (14%), two heart (9%), one intestinal (5%), one lung (5%), and one pancreas after kidney transplant (5%). The median time from SOT to PTLD diagnosis was 107 months. Pre-CAR-T bridging therapy was used in 55% of patients, and immunosuppression was stopped completely before CAR-T infusion in 64%. Eighteen (82%) patients experienced cytokine release syndrome: one (5%) each grade (G) 3 and G4. The immune effector cell-associated neurotoxicity syndrome was observed in 16 (73%) patients: six (27%) G3 and two (9%) G4. The overall response rate was 64% (55% complete response). Three patients (14%) experienced allograft rejection after CAR-T. The two-year progression-free survival and overall survival rates were 35% and 58%, respectively. Additionally, the achievement of CR post-CAR-T was strongly associated with survival. Collectively, the safety and efficacy of CD19 CAR-T therapy in relapsed/refractory SOT-related PTLD appeared similar to pivotal CAR-T data, including approximately one-third of patients achieving sustained remission.