2604.01651 CAR-T-CRS-GRADE v1: Transparent Pre-Validation Framework for Grade 3+ Cytokine Release Syndrome in CD19 CAR-T
CAR-T-CRS-GRADE v1: We present a pre-validation composite scoring framework for development of ASTCT grade >=3 CRS within 14 days of infusion in adult patients with relapsed/refractory B-cell lymphoma or leukaemia receiving commercial or investigational CD19 CAR-T products. Published literature reports grade >=3 CRS rates 10-50% depending on product and disease burden [Neelapu 2017; Schuster 2019; Maude 2018], with effect sizes for individual modifiers reported inconsistently across study designs and grading conventions.