Pilot Trial of Autologous Tumor Infiltrating Lymphocytes (LN-144) for Patients With Asymptomatic Melanoma Brain Metastases

This is an open label study evaluating lifileucel (LN-144) in patients with melanoma brain metastases.

Inclusion Criteria:Metastatic melanoma with asymptomatic brain metastasesAt least one resectable lesion (or aggregate of lesions resected) of a minimum 1.5 cm in diameter post-resection to generate TILMust be ≥ 18 years of age at time of consentECOG performance status of 0-1 and estimated life expectancy of ≥ 3 monthsAdequate hematologic parameters and organ functionExclusion Criteria:Received organ allograft, except kidney transplant, or prior cell transfer therapy including TIL and CAR-T therapiesOngoing 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 drugsSymptomatic brain metastasesChronic systemic steroid therapy of > 10 mg/dayActive medical illness(es) that would pose increased risk for protocol participationMust 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 undetectablePrimary immunodeficiencyReceived live or attenuated vaccine within 28 days prior to beginning NMA-LDPregnant or breastfeeding