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Peripheral Blood CD4/CD8 Ratio Predicts Out-of-Specification Products in Lisocabtagene Maraleucel Manufacturing
Taichi Hirano1, Hiro Tatetsu1, Shikiko Ueno1
1Department of Haematology, Rheumatology, and Infectious Diseases, Kumamoto University Hospital, Kumamoto, Japan.
Background:
Lisocabtagene maraleucel (liso-cel) is a CD19-directed chimeric antigen receptor T-cell therapy for patients with relapsed or refractory large B-cell lymphoma.
Methods:
In this retrospective study involving 22 patients, we evaluated the association between peripheral blood CD4/CD8 ratios and the occurrence of out-of-specification (OOS) products during manufacturing. Expanded access protocols have permitted the infusion of OOS products, despite their failure to meet commercial release criteria, under close regulatory oversight.
Results:
Five patients who received OOS products had significantly lower CD4/CD8 ratios (median 0.22 vs. 0.46; p = 0.008).
Conclusion:
Our findings suggest that a low CD4/CD8 ratio (below one-third) may be a predictive marker for OOS outcomes, potentially supporting patient selection and treatment planning. Therefore, prospective validation using a larger cohort is warranted.
