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Study of Lifileucel (LN-144), Autologous Tumor Infiltrating Lymphocytes, in the Treatment of Patients With Metastatic Melanoma | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Study of Lifileucel (LN-144), Autologous Tumor Infiltrating Lymphocytes, in the Treatment of Patients With Metastatic Melanoma

A Phase 2, Multicenter Study to Assess the Efficacy and Safety of Autologous Tumor Infiltrating Lymphocytes (LN-144) for Treatment of Patients With Metastatic Melanoma

NCT02360579•Iovance Biotherapeutics, Inc.

View on ClinicalTrials.gov

Summary

Prospective, interventional multicenter study evaluating adoptive cell therapy (ACT) via infusion of LN-144 (autologous TIL) followed by interleukin 2 (IL-2) after a nonmyeloablative lymphodepletion (NMA LD) preconditioning regimen.

Detailed Description

Lifileucel is an autologous adoptive cell transfer therapy that utilizes a TIL manufacturing process, as originally developed by the NCI, for the treatment of patients with metastatic melanoma. The adoptive cell transfer therapy used in this study involves patients receiving a lymphocyte depleting preconditioning regimen, prior to infusion of autologous TIL, followed by the administration of a regimen of IL-2.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Criteria for Inclusion:
•1. Patients with unresectable or metastatic melanoma (Stage IIIc or Stage IV)
•2. Patients must have progressed following ≥ one prior systemic therapy including a programmed cell death protein-1 (PD-1) blocking antibody; and if proto-oncogene B-Raf (BRAF) V600 mutation-positive, a BRAF inhibitor or BRAF inhibitor in combination with mitogen-activated extracellular signal-regulated kinase (MEK) inhibitor
•3. At least one measurable target lesion, as defined by RECIST v1.1
•* Lesions in previously irradiated areas (or other local therapy) should not be selected as target lesions, unless treatment was ≥ 3 months prior to Screening, and there has been demonstrated disease progression in that particular lesion
•4. At least one resectable lesion (or aggregate of lesions resected) of a minimum 1.5 cm in diameter post-resection to generate TIL; surgical removal with minimal morbidity (defined as any procedure for which expected hospitalization is ≤ 3 days)
•5. Patients must be ≥ 18 years of age at the time of consent. Enrollment of patients \> 70 years of age may be allowed after consultation with the Medical Monitor
•6. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and an estimated life expectancy of ≥ 3 months
•7. In the opinion of the Investigator, patients must be able to complete all study-required procedures
•8. Patients must have the following hematologic parameters:
+27 more criteria

Exclusion Criteria

•1. Patients who have been shown to be BRAF mutation positive (V600), but have not received prior systemic therapy with a BRAF inhibitor alone or a BRAF inhibitor in combination with a MEK inhibitor
•2. Patients who have received an organ allograft or prior cell transfer therapy
•3. Patients with melanoma of uveal/ocular origin
•4. Patients who have a history of hypersensitivity to any component or excipient of LN-144 or other study drugs:
•* NMA-LD preconditioning regimen (cyclophosphamide, mesna, and fludarabine)
•* Antibiotics (ABX) of the aminoglycoside group (ie, streptomycin, gentamicin); except those who are skin-test negative for gentamicin hypersensitivity
•* Any component of the LN-144 infusion product formulation including dimethyl sulfoxide (DMSO), human serum albumin (HSA), IL-2, and dextran-40
•5. Patients with symptomatic and/or untreated brain metastases (of any size and any number)
•* Patients with definitively treated brain metastases may be considered for Enrollment, and must be stable for ≥ 14 days prior to beginning the NMA LD preconditioning regimen
•6. Patients who are on chronic systemic steroid therapy for any reason
+13 more criteria

Locations (57)

University of California San Diego Moores Cancer Center

La Jolla, California, United States

The Angeles Clinic and Research Institute

Los Angeles, California, United States

University of California Los Angeles - David Geffen School of Medicine - Westwood Rheumatology

Los Angeles, California, United States

California Pacific Medical Center

San Francisco, California, United States

University of Colorado Cancer Center

Aurora, Colorado, United States

Yale Cancer Center

New Haven, Connecticut, United States

University of Miami

Miami, Florida, United States

Mount Sinai Comprehensive Cancer Center

Miami Beach, Florida, United States

University of Florida Health Cancer Center

Orlando, Florida, United States

University of South Florida H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Key Dates

Start Date

September 24, 2015

Primary Completion Date

October 24, 2024

Completion Date

October 24, 2024

Last Updated

December 9, 2025

Enrollment

220

ACTUAL participants

Conditions

Metastatic Melanoma

Interventions

Lifileucel

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 9, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Study of Lifileucel (LN-144), Autologous Tumor Infiltrating Lymphocytes, in the Treatment of Patients With Metastatic Melanoma

Inclusion Criteria

Exclusion Criteria

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