Expanded Access Program of Lifileucel (LN-144) in Patients With Unresectable or Metastatic Melanoma

Study Overview
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Brief Summary
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This is an open label, multi-center expanded access treatment protocol evaluating lifileucel (LN-144) in patients with unresectable or metastatic melanoma.

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 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.

Official Title
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An Expanded Access Program of Lifileucel, Autologous Tumor Infiltrating Lymphocytes (TIL; LN-144), for Patients With Unresectable or Metastatic Melanoma

Conditions
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Unresectable Melanoma, Metastatic Melanoma

Intervention / Treatment
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* Biological: Lifileucel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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) 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 Primary immunodeficiency Received live or attenuated vaccine within 28 days prior to beginning NMA-LD Pregnant or breastfeeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Lifileucel|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TIL, LN-144, Lifileucel, Adoptive Cell Therapy, Cell Therapy, Tumor Infiltrating Lymphocytes, Immunotherapy, Melanoma, Cutaneous Melanoma, Mucosal Melanoma, Acral Melanoma