TIL cell therapy in HIV positive patient with metastatic melanoma: case report.

Tumor-infiltrating lymphocyte (TIL) therapy is an emerging treatment for patients with metastatic melanoma whose disease has progressed on immune checkpoint inhibitors. However, individuals living with well-controlled human immunodeficiency virus (HIV) have historically been excluded from clinical trials evaluating adoptive cell therapies, leaving uncertainty regarding safety, tolerability, immune effects, and oncologic response in this population. We present the first known case of a patient with virologically suppressed HIV receiving TIL therapy for immunotherapy-refractory metastatic melanoma. A 37-year-old man with long-standing HIV on antiretroviral therapy (ART) developed rapidly progressive, BRAF-V600E mutant metastatic melanoma involving bulky axillary disease and pulmonary metastases despite anti-PD-1 therapy, combined checkpoint blockade, and BRAF/MEK-targeted therapy. His course prior to TIL therapy was notable for minimal treatment-related toxicities and intermittent detectable low-level HIV viremia. After multidisciplinary review, he underwent TIL harvest followed by lymphodepleting chemotherapy, lifileucel infusion, and high-dose interleukin-2 (IL-2). TIL therapy was tolerated with expected toxicities, including grade 1 cytokine release syndrome and IL-2-associated grade 3 hypotension requiring brief vasopressor support. At day 44, imaging demonstrated a partial response with decreased pulmonary metastases and stabilization of axillary disease. Progression of disease was observed by day 86. CD4 counts fluctuated markedly throughout treatment, though virologic suppression was ultimately restored by day 100. This case demonstrates that TIL therapy can be feasibly administered to a patient with well-controlled HIV, with manageable toxicity and early radiographic response. These findings underscore the need for prospective inclusion of people living with HIV in cellular therapy trials to better characterize safety, immune dynamics, and predictors of durable benefit.