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Rondecabtagene autoleucel (ronde-cel; LYL314) is an autologous, next-generation dual-targeting chimeric antigen receptor (CAR) T-cell therapy developed by Lyell Immunopharma for the treatment of relapsed or refractory large B-cell lymphoma (LBCL). It is engineered with an 'OR' logic gate to target B cells expressing either CD19, CD20, or both, which is intended to increase complete response rates and prolong response duration by mitigating antigen escape compared to single-target CD19 CAR T-cell therapies. The product is manufactured using a proprietary process that enriches for CD62L-expressing cells, resulting in a CAR T-cell population with higher proportions of naïve and central memory T cells to potentially enhance potency and persistence. Rondecabtagene autoleucel has received Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the FDA for the treatment of patients with R/R LBCL in the third-line or later (3L+) setting and is also being evaluated in the second-line (2L) setting.
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