A Study of LN-144 in People With Metastatic Melanoma to the Brain

Lifileucel (LN-144) is an autologous Tumor Infiltrating Lymphocytes (TIL) cell therapy that utilizes a 22-day centralized GMP process. Lifileucel is infused as part of a treatment regimen that includes preparative NMA-LD, followed by one-time autologous TIL infusion, and a short course of high-dose IL-2.

Inclusion criteria

• Metastatic melanoma with asymptomatic brain metastases
• At least one resectable lesion (or aggregate of lesions resected) of a minimum 1.5 cm in diameter post-resection to generate TIL
• Must be ≥ 18 years of age at time of consent
• ECOG performance status of 0-1 and estimated life expectancy of ≥ 3 months
• Adequate hematologic parameters and organ function

Exclusion criteria

• Received organ allograft, except kidney transplant, or prior cell transfer therapy including TIL and CAR-T therapies
• Ongoing grade 2-4 toxicity from prior immunotherapy (excluding endocrine, ocular toxicity or vitiligo)
• History of hypersensitivity to any component or excipient of lifileucel or other treatment regimen drugs
• Symptomatic brain metastases
• Chronic systemic steroid therapy of > 10 mg/day
• Active medical illness(es) that would pose increased risk for protocol participation
• Must have negative syphilis assay and be seronegative for HIV, positive serology for HBV must have corresponding PCR assay and may be enrolled if viral load by PCR is undetectable
• Primary immunodeficiency
• Received live or attenuated vaccine within 28 days prior to beginning NMA-LD
• Pregnant or breastfeeding
• Patients who cannot receive gadolinium-enhanced MRI.