biostudies-literatureUnknown207(3)Jo TEfficacy of chimeric antigen receptor (CAR) T-cell therapy hinges on CAR-T potency, as well as on tumour traits and disease status. Potency assessment currently relies on post-infusion in vivo growth; therefore, manufacturing metrics could provide early potency predictions, enabling potency-guided strategies. To assess the impact of ex vivo cell growth during manufacturing on clinical outcomes, we analysed diffuse large B-cell lymphoma patients treated with tisagenlecleucel, merging clinical records with manufacturing parameters. Of 75 cases, 21 (28%) showed poor growth, indicated by any decrease in cell number during manufacturing. Good growth correlated with significantly better overall response rate (85.2% vs. 52.4%; p = 0.006), with enhanced lymphocyte increase in peripheral blood afteBritish journal of haematology1002-1010https://www.ebi.ac.uk/biostudies/studies/S-EPMC12436216biostudies-literatureConsistent ex vivo cell proliferation during manufacturing predicts favourable outcomes post-CAR-T-cell therapy.PMC12436216Kitawaki TMizumoto CShimizu TTakaori-Kondo AKanda JJo TNagao MArai YNishikori MYamashita KSakamoto TfalseConsistent ex vivo cell proliferation during manufacturing predicts favourable outcomes post-CAR-T-cell therapy.Efficacy of chimeric antigen receptor (CAR) T-cell therapy hinges on CAR-T potency, as well as on tumour traits and disease status. Potency assessment currently relies on post-infusion in vivo growth; therefore, manufacturing metrics could provide early potency predictions, enabling potency-guided strategies. To assess the impact of ex vivo cell growth during manufacturing on clinical outcomes, we analysed diffuse large B-cell lymphoma patients treated with tisagenlecleucel, merging clinical records with manufacturing parameters. Of 75 cases, 21 (28%) showed poor growth, indicated by any decrease in cell number during manufacturing. Good growth correlated with significantly better overall response rate (85.2% vs. 52.4%; p = 0.006), with enhanced lymphocyte increase in peripheral blood afte2025-01-01T00:00:00Z2025 Sep2026-04-08T19:53:01.331Z2026-04-08T14:35:53.717ZS-EPMC124362164063393310.1111/bjh.20266