Peripheral Blood CD4/CD8 Ratio Predicts Out-of-Specification Products in Lisocabtagene Maraleucel Manufacturing.
1/5 보강
PICO 자동 추출 (휴리스틱, conf 3/4)
유사 논문P · Population 대상 환자/모집단
22 patients, we evaluated the association between peripheral blood CD4/CD8 ratios and the occurrence of out-of-specification (OOS) products during manufacturing.
I · Intervention 중재 / 시술
OOS products had significantly lower CD4/CD8 ratios (median 0
C · Comparison 대조 / 비교
추출되지 않음
O · Outcome 결과 / 결론
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.
[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.
- p-value p = 0.008
APA
Hirano T, Tatetsu H, et al. (2025). Peripheral Blood CD4/CD8 Ratio Predicts Out-of-Specification Products in Lisocabtagene Maraleucel Manufacturing.. Cancer reports (Hoboken, N.J.), 8(12), e70413. https://doi.org/10.1002/cnr2.70413
MLA
Hirano T, et al.. "Peripheral Blood CD4/CD8 Ratio Predicts Out-of-Specification Products in Lisocabtagene Maraleucel Manufacturing.." Cancer reports (Hoboken, N.J.), vol. 8, no. 12, 2025, pp. e70413.
PMID
41307214
Abstract
[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.
[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.
MeSH Terms
Humans; Retrospective Studies; Male; Female; Middle Aged; Immunotherapy, Adoptive; Aged; CD4-CD8 Ratio; Antigens, CD19; Lymphoma, Large B-Cell, Diffuse; Receptors, Chimeric Antigen; Adult
같은 제1저자의 인용 많은 논문 (5)
- Favorable clinical impact of histological subtype with non-small cell carcinoma-not otherwise specified in patients with non-small cell lung cancer receiving immune checkpoint inhibitors.
- Early Liver Metastasis from Early Gastric Adenocarcinoma with a Small Neuroendocrine Carcinoma Component: A Case Report.
- Pediatric Alpha-Fetoprotein-Producing Gastric Cancer Presenting With Dysphagia and Multiple Liver Tumors.
- [Follicular Thyroid Carcinoma Detected by Cervical Palpation in a Young Patient-A Case Report].
- Reconstruction using a free jejunal patch flap in salvage head and neck surgery after radiotherapy.