A Study of LN-144 in People With Metastatic Melanoma to the Brain

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

Detailed Description
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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.

Official Title
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Pilot Trial of Lifileucel (LN-144) for Patients With Asymptomatic Melanoma Brain Metastases and Progression on Prior PD1 Therapy

Conditions
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Metastatic Melanoma

Intervention / Treatment
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* Biological: Lifileucel (LN-144)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants with Melanoma Brain Metastases<br>Participants have melanoma brain metastases who will undergo surgical excision to generate LN-144. | Biological: Lifileucel (LN-144)<br>* A portion of the patient's tumor is resected and serves as the starting material for manufacturing lifileucel. After preparative NMA-LD, patients are infused with their autologous TIL (lifileucel), followed by a short course of high-dose IL-2.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of treatment with LN-144 in patients with asymptomatic Metastatic Melanoma to the Brain (MMB) | measured by the number of patients who undergo surgery and successfully undergo LN-144 infusion | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LN-144, Non-uveal melanoma, Lifileucel (LN-144), 22-322