Consistent ex vivo cell proliferation during manufacturing predicts favourable outcomes post-CAR-T-cell therapy.

ABSTRACT: 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 afte

SUBMITTER: Jo T 

PROVIDER: S-EPMC12436216 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature