Frigault MJ, Dietrich J, Gallagher KME, et al. Safety and Efficacy of Tisagenlecleucel in Primary CNS Lymphoma: A Phase I/II Clinical Trial. Blood. 2022; (doi: 10.1182/blood.2021014738).
A Phase I/II clinical trial demonstrated that tisagenlecleucel is a safe and effective treatment for primary central nervous system lymphoma (PCNSL). For the study, 12 relapsed PCNSL patients were treated with tisagenlecleucel and monitored for a median of 12.2 months. A response was seen in seven patients (58.3%). Six patients (50%) experienced a complete response, and three (42.9%) had a sustained remission. Overall, seven patients (58.3%) exhibited grade 1 cytokine release syndrome, five (41.6%) had grade 2 immune cell associated neurotoxicity syndrome (ICANS), and one had grade 3 ICANS. No treatment-related deaths occurred. The CD19 directed CAR-T immunotherapy expanded in the peripheral blood and went to the CNS. Analysis indicated the post-infusion presence of T-cell, CAR T-cell, and macrophage gene signatures in cerebrospinal fluid compared with baseline.