Clinical determinants of survival outcomes and acute toxicity after adoptive cellular therapy for solid tumors.

BACKGROUND: The efficacy of cellular therapies has been demonstrated in hematologic malignancies, and their use is expanding to solid tumors. Predictors of outcomes and toxicities remain limited in patients undergoing cellular therapies for solid tumors. METHODS: Data on patients with solid tumors who received cellular therapies between January 2016 and July 2025 in the Department of Investigational Cancer Therapeutics (Phase I Clinical Trials Program) at The University of Texas MD Anderson Cancer Center were reviewed retrospectively using the institutional CHIMERA database platform. RESULTS: Among 122 patients, increased baseline C-reactive protein (CRP) was associated with shorter overall survival (OS) (hazard ratio [HR] 1.009, 95% confidence interval (CI) 1.005-1.013; P < 0.001), and higher log-transformed cell dose was associated with longer progression-free survival (PFS) (HR 0.636, 95% CI 0.476-0.850; P = 0.002). Among patients with baseline pulmonary function testing, zDLCO was associated with OS (HR 0.794, 95% CI 0.674-0.936; P = 0.006) and PFS (HR 0.826, 95% CI 0.696-0.979; P = 0.028). Cytokine release syndrome (CRS) occurred in 70 participants (57.4%). In the multivariate analysis, lower baseline absolute neutrophil count was associated with CRS of any grade (odds ratio [OR] 0.594, 95% CI 0.376-0.939; P = 0.026) and with CRS grade 2 or higher (OR 0.470, 95% CI 0.252-0.877; P = 0.018). Immune effector cell-associated neurotoxicity syndrome developed in 11 patients (9.0%). CONCLUSIONS: Baseline parameters such as CRP and pulmonary function may help identify patients at higher risk of adverse outcomes and toxicity during cellular therapy for solid tumors, and warrant prospective evaluation.