Temporal clinical trajectories and Day+14 landmark stratification of infection risk after CD19 CAR T-cell therapy.
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BACKGROUND: Infection after CD19-directed chimeric antigen receptor T-cell (CAR-T) therapy develops over a changing clinical course. We examined two related questions: how completed Day+100 registry data characterize the infection-associated clinical phenotype, and whether information available by Day+14 can stratify subsequent infection risk through Day+100. METHODS: We analyzed 3,302 adults with large B-cell lymphoma using a 70:30 development/test partition. An all-history classifier used completed Day+100 records. The corrected Day+14 cohort included 2,876 patients with observation extending beyond the landmark; models used information available by Day+14. Supplemental outer cross-validation repeated development, and logistic recalibration used development cross-fitted scores. A separate common-feature model was evaluated in 465 pediatric and young-adult patients with B-cell acute lymphoblastic leukemia. RESULTS: Infection was recorded in 735/3,302 adults (22.3%). The all-history test AUROC was 0.724 (95% CI, 0.685-0.765). In the corrected Day+14 test set (862 patients; 113 infections), the dynamic-model AUROC was 0.669 (95% CI, 0.616-0.716) and AUPRC was 0.217 (95% CI, 0.165-0.286). At score cutoff 0.25, the low-score group contained 160/862 patients (18.6%) and 5 infections (3.1%; 95% CI, 1.0-7.1%). Its raw and recalibrated Brier scores were 0.198 and 0.110, compared with 0.114 for the development-prevalence reference. In the cross-disease evaluation, the common-feature model achieved an AUROC of 0.663. CONCLUSIONS: Completed records characterize infection-associated clinical trajectories. Day+14 information identifies a low-score subgroup for prospective evaluation of outpatient monitoring, with its coverage, event rate and calibration defining the conditions for that evaluation.