Related Experiment Video
Updated: Jan 10, 2026
06:18
Author Spotlight: Advancements in CAR-T Cell Manufacturing and Gene Therapy Production
Published on: August 18, 2023
3.6K
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.
Cancer Reports (Hoboken, N.J.)
|November 27, 2025
Summary
A low CD4/CD8 ratio may predict out-of-specification (OOS) products in lisocabtagene maraleucel (liso-cel) manufacturing. This finding could aid patient selection for chimeric antigen receptor T-cell therapy in large B-cell lymphoma.
Area of Science:
- Immunology
- Oncology
- Cell Therapy
Background:
- Lisocabtagene maraleucel (liso-cel) is a CD19-directed chimeric antigen receptor T-cell therapy.
- It is used for relapsed or refractory large B-cell lymphoma.
Purpose of the Study:
- To investigate the association between peripheral blood CD4/CD8 ratios and out-of-specification (OOS) products during liso-cel manufacturing.
- To explore the predictive value of CD4/CD8 ratios for OOS outcomes.
Main Methods:
- Retrospective study of 22 patients undergoing liso-cel therapy.
- Evaluation of peripheral blood CD4/CD8 ratios in relation to OOS product occurrence.
- Analysis of OOS product infusion under expanded access protocols.
Main Results:
- Five patients who received OOS products had significantly lower CD4/CD8 ratios (median 0.22 vs. 0.46; p = 0.008).
- A CD4/CD8 ratio below one-third was observed in patients with OOS outcomes.
Conclusions:
- A low CD4/CD8 ratio may serve as a predictive marker for OOS outcomes in liso-cel manufacturing.
- This finding could support patient selection and treatment planning for CAR T-cell therapy.
- Prospective validation in a larger cohort is recommended.
