Insights From Liso-cel Combined With Ibr for R/RCLL/SLL: Primary Results From the Open-Label, Phase 1/2 Transcend CLL 004 Study

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Open-Label, Phase 1/2 Transcend CLL 004 Study

The Transcend CLL 004 Study is an open-label, phase 1/2 trial that evaluated the combination of lisocabtagene maraleucel (liso-cel), a CD19-directed chimeric antigen receptor (CAR) T-cell therapy, with ibrutinib, a Bruton tyrosine kinase inhibitor, in patients with R/R CLL or R/R SLL.

Primary Findings:

• The combination of liso-cel and ibrutinib demonstrated promising efficacy in patients with R/R CLL/SLL.
• The treatment regimen showed a high overall response rate, with many patients achieving complete response or partial response.
• Liso-cel was administered after a bridging therapy of ibrutinib, with the combination showing manageable safety profiles.
• The addition of ibrutinib to liso-cel may enhance the expansion and persistence of CAR T cells, potentially improving clinical outcomes compared with standard CAR T-cell therapy alone.

Safety Profile:

• The safety of the liso-cel and ibrutinib combination was in line with expectations based on prior studies of these agents.
• Common adverse events included cytokine release syndrome and neutropenia, both of which were manageable with appropriate intervention.
• There was no increase in the incidence of immune effector cell–associated neurotoxicity syndrome when compared with previous CAR T-cell therapy studies.

Conclusion:

The Transcend CLL 004 study suggests that combining liso-cel with ibrutinib may offer an effective therapeutic approach for patients with R/R CLL/SLL, with manageable safety and significant clinical benefit. Further clinical trials will be needed to confirm these findings and optimize treatment regimens for this patient population.