(163) Infectious Complications Following Chimeric Antigen Receptor T-Cell Therapy

Poster Abstract:

Background: Chimeric antigen receptor (CAR) T-cell therapies have transformed the treatment of several malignancies, including acute lymphoblastic leukemia (ALL), non-Hodgkin lymphoma (NHL), and multiple myeloma (MM). In a patient population that is already immunocompromised, CAR T-cell therapy is associated with its own increased risk for infection. Many factors contribute to this increased risk, including lines of prior therapy, proceeding lymphodepleting chemotherapy, type of CAR-T product infused, and subsequent prolonged cytopenias. In pivotal clinical trials, infections occurred after cell infusion in 19-56% and 42-69% of patients receiving CD19- and BCMA-directed therapies, respectfully. Time from infusion to infection was not standardized across clinical trials. Additional factors that can further exacerbate this risk are the administration of corticosteroids and tocilizumab for management of toxicities secondary to CAR T-cell therapy. When used for the treatment of rheumatoid arthritis and COVID-19 infections, tocilizumab administration has been associated with an increased infection risk. Some univariate analyses have suggested an increased infection risk with tocilizumab following its use in managing cytokine release syndrome, however, no multivariable analyses have demonstrated association.

Objective: The objective of this study is to determine if tocilizumab administration leads to a higher incidence of infection within 90 days of receiving CAR T-cell infusion.

Methods: This is a retrospective, single-center chart review study from June 1, 2018 through August 21, 2023 including approximately 200 patients of at least 18 years of age who received an FDA-approved CAR-T treatment. CAR-T products administered include tisagenlecleucel (Kymriah®), axicabtagene ciloleucel (Yescarta®), brexucabtagene autoleucel (Tecartus®), lisocabtagene maraleucel (Breyanzi®), idecabtagene vicleucel (Abecma®), and ciltacabtagene autoleucel (Carvykti®). Patients who received CAR-T through any protocol for a non-FDA approved indication will be excluded. Patients who received tocilizumab will be compared to patients who did not. It is anticipated that there will be approximately 100 patients in each group. The primary outcome is the incidence of documented infection. Secondary outcomes include: type of infection, infectious related death, overall survival (OS), progression free survival (PFS), and overall response rate at 30 and 90 days. Data will be collected through manual chart review. Chi-square or Fischer’s exact tests will be used for nominal data and T-tests or Mann Whitney U tests will be used for continuous data. Binary logistic regression will be performed to further assess variables associated with the incidence of documented infection. Kaplan Meier survival will be used to assess PFS and OS.

Results: Results are pending.

Discussion/

Conclusions: Discussion and conclusions are pending.

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