Comparing outcomes of lymphoma-directed CAR T-cell therapy in patients with and without HIV: A retrospective cohort study from a global health research network.

7034 Background: Since its introduction into the world of oncology, chimeric antigen receptor (CAR) T-cell therapy has revolutionized the treatment of relapsed and refractory lymphomas. However, patients with HIV (PWH) have historically been excluded from CAR T-cell studies. This is likely due to assumed decreased efficacy and increased infection-related morbidity and mortality due to their immunocompromised status. This lack of understanding contributes to healthcare disparities, resulting in fewer individuals from this vulnerable population receiving this innovative treatment. Thus, this study aims to compare the 1-year survival and safety outcomes of CAR T-cell therapy for Hodgkin and Non-Hodgkin lymphomas in adult patients with and without HIV. Methods: Using TriNetX global health research network, we identified 35 PWH who received lymphoma-directed CAR T-cell therapy. For the control group, we identified 2,575 patients without HIV who received lymphoma-directed CAR T-cell therapy. We then conducted a log-rank test and calculated relative risks (RR) to compare outcomes in 1-year overall survival (OS) and incidence of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), bacteremia and sepsis. Results: In our group of PWH, we observed a mean age of 56.1+/-12.6 years at time of CAR T-cell therapy, compared to a mean age of 63.0+/-13.0 years in our group of patients without HIV. RR analysis demonstrated significantly increased 1-year risk for development of sepsis (RR=1.75, 95%CI 1.03, 2.97) and bacteremia (RR=2.41, 95%CI 1.41, 4.12) in our group of PWH. However, it showed no statistically significant differences in risk for development of CRS (RR=1.11, 95%CI 0.788, 1.57), ICANS (RR=1.23, 95%CI 0.723, 2.08), or death from any cause (RR=1.43, 95%CI 0.873, 2.35). Log rank test revealed no significant differences in 1-year OS (p=0.208) or incidence of CRS (p=0.567), ICANS (p=0.223), bacteremia (p=0.561) or sepsis (p=0.225). Median OS was not reached in either group. Conclusions: This data supports that PWH may be at increased risk of infectious complications, but not increased mortality, following lymphoma-directed CAR T-cell therapy. While this study is limited by a small cohort size, its results support the need to include PWH in future clinical trials to better understand the effect of HIV infection on CAR T-cell treatment outcomes.