Melanoma Clinical Trial
A Study of LN-144 in People With Metastatic Melanoma to the Brain
Summary
The researchers are doing this study to find out whether it is practical to treat study participants' metastatic melanoma tumors with LN-144. Some practical steps the study doctors will study are whether LN-144 can be made quickly for each participant, if enough tumor samples are collected for the study therapy or whether there are complications during the surgical procedure. We will also look at whether LN-144 is a safe and effective treatment for melanoma tumors in the brain.
Full Description
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.
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.
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There is 1 Location for this study
New York New York, 10065, United States
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