A Study of LN-144 in People With Metastatic Melanoma to the Brain
Metastatic Melanoma
About this trial
This is an interventional treatment trial for Metastatic Melanoma focused on measuring LN-144, Non-uveal melanoma, Lifileucel (LN-144), 22-322
Eligibility Criteria
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.
Sites / Locations
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)Recruiting
Arms of the Study
Arm 1
Experimental
Participants with Melanoma Brain Metastases
Participants have melanoma brain metastases who will undergo surgical excision to generate LN-144.