Multicenter phase 1-2 trial of lisocabtagene maraleucel for chronic lymphocytic leukemia and small lymphocytic lymphoma

Patients with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) for whom treatment has failed with both Bruton tyrosine kinase (BTK) inhibitor and venetoclax have few treatment options and poor outcomes. The multicenter phase 1-2 TRANSCEND CLL 004 trial in the USA evaluated lisocabtagene maraleucel (liso-cel) for R/R CLL and SLL after at least two previous lines of therapy, including a BTK inhibitor. A single infusion of liso-cel was shown to induce complete response or remission (including with incomplete marrow recovery) in 18% of patients with R/R CLL or SLL, including patients who had experienced disease progression of BTK inhibitor and venetoclax failure. The safety profile was manageable.