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A Study of LN-144 or LN-145 in People With Advanced Uveal Melanoma, Undifferentiated Pleomorphic Sarcoma, or Dedifferentiated Liposarcoma | Clinical Trials | Clareo Health

RECRUITINGPHASE1

A Study of LN-144 or LN-145 in People With Advanced Uveal Melanoma, Undifferentiated Pleomorphic Sarcoma, or Dedifferentiated Liposarcoma

A Pilot Trial of Autologous Tumor Infiltrating Lymphocytes (LN-144 or LN-145) for Patients With Advanced Uveal Melanoma, Undifferentiated Pleomorphic Sarcoma, or Dedifferentiated Liposarcoma

NCT05607095•Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

Summary

This is an open label study evaluating lifileucel (LN-144) in patients with metastatic uveal melanoma.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Cohort 1: Must have a confirmed diagnosis of metastatic Uveal Melanoma.
•Patients will be eligible regardless of the number of prior systemic therapies received.
•* Cohort 2: Must have a confirmed diagnosis of unresectable or metastatic undifferentiated pleomorphic sarcoma (UPS) or dedifferentiated liposarcoma (DDLPS) that is refractory to at least 1 prior line of systemic therapy
•Unresectable disease will be defined by an expert sarcoma surgical onocologist as either (a) low liklihood of obtaining an R0 resection or (b) unacceptable morbidity from a surgical procedure
•Prior systemic therapy in the neoadjuvant or adjuvant setting will count has prior systemic therapy
•Patients who refuse standard of care chemotherapy will be eligible
•* One (1) lesion at least 1.5cm in size (solitary or aggregate) available for TIL harvesting that has not undergone prior embolization or RT in prior 3 months unless subsequent growth is demonstrated (at least 0.5cm).
•* Patients must be ≥ 18 years of age at the time of consent.
•* Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
•* Patients must have an estimated life expectancy of ≥ 6 months in the opinion of the Investigator.
+35 more criteria

Exclusion Criteria

•Patients who have received an organ allograft or prior cell transfer therapy that included a non-myeloablative or myeloablative chemotherapy regimen.
•Patients who have a history of hypersensitivity to any component or excipient of LN-144/LN-145 or other study drugs:
•* NMA-LD preconditioning regimen (cyclophosphamide, mesna, and fludarabine)
•* Proleukin®, aldesleukin, IL-2
•* Antibiotics (ABX) of the aminoglycoside group (i.e., streptomycin, gentamicin); except those who are skin-test negative for gentamicin hypersensitivity
•* Any component of the LN-144/LN-145 infusion product formulation including dimethyl sulfoxide (DMSO), human serum albumin (HSA), IL-2, and dextran-40.
•Patients with symptomatic brain metastases (of any size and any number).
•o Patients with definitively treated brain metastases may be considered for enrollment, if, prior to tumor resection for TIL, the patient is clinically stable for ≥ 14 days, there are no symptomatic brain lesions, and that the patient does not require ongoing corticosteroid treatment.
•Patients who are on chronic systemic immunosuppressive therapy except for those requiring steroid therapy for management of adrenal insufficiency; these patients may receive no more than 10 mg of prednisone or its equivalent daily. Transient use of steroids, e.g. in the perioperative period, is not an exclusion.
•Patients who are pregnant or breastfeeding.
+23 more criteria

Locations (2)

Memorial Sloan Kettering Westchester

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Key Dates

Start Date

November 1, 2022

Primary Completion Date

May 1, 2026

Completion Date

May 1, 2026

Last Updated

February 4, 2026

Enrollment

ESTIMATED participants

Conditions

Uveal MelanomaMelanomaMetastatic Uveal MelanomaMetastatic Melanoma

Interventions

Lifileucel (LN-144/LN-145)

BIOLOGICAL

Contacts

Alexander Shoushtari, MD

CONTACT

646-888-4161 shoushta@mskcc.org

Lauren Banks, MD, PhD

CONTACT

646-888-6784 BanksL1@mskcc.org

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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: February 4, 2026Data 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

A Study of LN-144 or LN-145 in People With Advanced Uveal Melanoma, Undifferentiated Pleomorphic Sarcoma, or Dedifferentiated Liposarcoma

Inclusion Criteria

Exclusion Criteria

IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors

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