Influence of HIV on outcomes in patients with diffuse large B cell lymphoma treated with CD19 targeting CAR-T cell therapy.

Abstract

7076 Background: HIV+ patients have an 18-fold increased risk of developing diffuse large B Cell Lymphoma (DLBCL). There is uncertainty in the literature regarding the safety and efficacy of chimeric antigen receptor T-cell (CAR-T) therapy in HIV+ patients. This study aims to evaluate the influence of HIV infection on outcomes in patients treated with CD19 targeting CAR-T therapy. Methods: This is a multicenter retrospective cohort study that included patients with co-diagnosis of DLBCL and HIV who received a CD19 targeting CAR-T in the TriNetX Network, a database of deidentified electronic medical records with over 130 million patient records. Outcomes comprised of 5-year mortality, development of cytokine release syndrome (CRS), development of immune effector cell-associated neurotoxicity syndrome (ICANS), risk of infection, hypogammaglobinemia, and treatment with Tocilizumab , G-CSF, or IVIG. Results: Eighty-one patients met inclusion criteria. The mean current age was 62 years old, 75.6% were White, 16.3% were Black, 11.6% were Asian, and 73.3% were male. Approximately 72% of patients received Fludarabine/Cyclophosphamide, while 19% received Bendamustine as lymphodepletion chemotherapy. Within the cohort, 42% died within 5 years; 58% developed infection following treatment with CD19 targeting CAR-T therapy. The risks for CRS and ICANS were 65% and 14%, respectively; 53% treated with tocilizumab. Approximately 46% of patients developed hypogammaglobinemia; 31% were treated with IVIG, and 44% were treated with G-CSF. Further analysis to assess effect of development of CRS on outcomes showed no significant difference in survival probability among patients with or without CRS. Conclusions: CD19 CAR-T therapies have emerged for patients with refractory or relapsed DLBCL; however, HIV+ patients have been excluded from all registration CAR-T Cell clinical trials. Compared to the general population, our study demonstrates HIV+ patients with DLBCL have a similar mortality and morbidity rates when treated with CD19 targeted CAR-T therapy, indicating that in the future perhaps these patients should not be excluded from clinical trials. Outcomes Patients in Cohort Patients with Outcome Risk (%) Mortality 81 34 42% CRS 81 53 65.4% CRS Grade 1 or 2 81 21 25.9% CRS 3, 4, or 5 81 20 24.7% ICANS 81 11 13.6% Overall Infection 81 47 58% Bacterial Infection 81 24 29.6% Viral Infections 81 23 28.4% Treatment with Tocilizumab 81 43 53.1% Hypogammaglobulinemia 81 37 45.7% Treatment with IVIG 81 25 30.9% Treatment with G-CSF 81 36 44.4%