Safety and feasibility of outpatient CAR-T therapy: A single center analysis.

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e19005 Background: Chimeric Antigen Receptor modified R Cell Immunotherapy (CAR-T) cell products have revolutionized the landscape of treatment of relapsed and refractory (R/R) B-cell malignancies and multiple myeloma. Yet, these therapies emerged with their own challenges, Cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) are the most common and serious adverse events. The model of CAR-T cell therapy in the University of Oklahoma is unique as it is designated as an outpatient therapy. Little is known regarding risk factors for hospitalization after CAR-T therapy. Methods: This is a retrospective analysis of all consecutive adult patients who had CAR-T therapy from 9/1/2019 through 9/30/2023 at the University of Oklahoma Health Sciences Center (OUHSC). Inclusion criteria were adult patients with hematologic malignancies who received an FDA approved CAR-T therapy. Exclusion criteria included patients who were younger than 18 at the time of infusion, those who received cellular therapy for solid tumors and those who received investigational CAR-T cell products. Descriptive statistics were created for continuous and categorical variables. Chi-Square analysis and independent samples t-tests were used to measure association with hospital admission and treatment response. Logistic regression was used to explore associations for all covariates with each outcome. SAS 9.4 was used to perform all analysis. An alpha of 0.05 was used to determine significance. Results: A total of 118 patients received outpatient CAR-T/Cellular therapy at OUHSC during the study period with 78 patients meeting the inclusion criteria. The mean age at time of infusion was 58.6 (range=18-85) with most being male (n=46, 59.0%), White (n=63, 80.8%), and overweight/obese (n=50, 64.1%). The majority of patients received anti CD19 CAR-T (n=64, 82.1%) while 18.0% received anti BCMA products. CRS grade 0,1 occurred in 79.5% of patients (n=62) and 79.2% of patients were hospitalized within 30 days after CAR-T therapy (Median day of admission post CAR-T=5.5). Of patients who were hospitalized 26% had grades 2-4 CRS. Complete remission was achieved in 54.7% of patients. We compared the hospitalized and non-hospitalized patients across multiple characteristics, there was no association or predictors of hospitalization found. Albumin was the only predictor for CR. Conclusions: Our study provides data for safety and feasibility of outpatient CAR-T therapy despite potential risks for hospitalization. There are no clear predictors for hospitalizations after CAR-T therapy except for the development of CRS and ICAN. Higher baseline (pre-CAR-T) serum Albumin level was associated with higher odds of achieving CR.