Melanoma Clinical Trial
Pilot Trial of Autologous Tumor Infiltrating Lymphocytes (LN-144) for Patients With Metastatic Uveal Melanoma
Summary
The purpose of this is study to find out whether it is practical to make LN-144 from study participants' collected cells. The study will also look at whether LN-144 is a safe treatment for metastatic uveal melanoma
Eligibility Criteria
Inclusion Criteria:
Metastatic uveal melanoma
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 and/or untreated 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
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