Melanoma Clinical Trial
Expanded Access Program of Lifileucel (LN-144) in Patients With Unresectable or Metastatic Melanoma
This is an open label, multi-center expanded access treatment protocol evaluating lifileucel (LN-144) in patients with unresectable or metastatic melanoma.
Lifileucel (LN-144) is an autologous Tumor Infiltrating Lymphocytes (TIL) cell therapy that utilizes a 22-day centralized GMP process for the treatment of patients with advanced melanoma. 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.
Unresectable or metastatic melanoma (Stages IIIC/IIID/IV per AJCC 8th edition)
Progressed on or did not achieve a response or were intolerant due to toxicity following 1-4 prior lines of systemic therapy including PD-1/ PD-L1 blocking antibody.
May have received adjuvant PD-1/PD-L1 blocking antibody if recurred within 6 months of discontinuation of therapy or while on therapy
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
There is no alternative therapy
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)
Melanoma of uveal/ocular origin
History of hypersensitivity to any component or excipient of lifileucel or other treatment regimen drugs
Symptomatic and/or untreated brain metastases, unless definitively treated and stable for ≥ 14 days prior to beginning NMA LD preparative regimen
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
Received live or attenuated vaccine within 28 days prior to beginning NMA-LD
Pregnant or breastfeeding
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There are 6 Locations for this study
Scottsdale Arizona, 85258, United States
Orlando Florida, 32806, United States
Louisville Kentucky, 40202, United States
Saint Louis Missouri, 63110, United States
New York New York, 10065, United States
Knoxville Tennessee, 37920, United States
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