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
1 other identifier
interventional
30
1 country
2
Brief Summary
This is an open label study evaluating lifileucel (LN-144) in patients with metastatic uveal melanoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Nov 2022
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 1, 2022
CompletedStudy Start
First participant enrolled
November 1, 2022
CompletedFirst Posted
Study publicly available on registry
November 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedFebruary 4, 2026
February 1, 2026
3.5 years
November 1, 2022
February 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse events as evaluated by CTCAE v5.0
Safety will be measured descriptively using CTCAE v5.0 for all patients who undergo surgical excision.
Up to 3 years
Study Arms (2)
Participants with Metastatic Uveal Melanoma
EXPERIMENTALParticipants have metastatic uveal melanoma who will undergo surgical excision to generate LN-144/LN-145
Participants with Metastatic Sarcoma
EXPERIMENTALParticipants have metastatic sarcoma who will undergo surgical excision to generate LN-144/LN-145
Interventions
Lifileucel (LN-144/LN-145) 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
You may qualify if:
- 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.
- Patients must have the following hematologic parameters:
- Absolute neutrophil count (ANC) ≥ 1000/mm3
- Hemoglobin (Hb) ≥ 9.0 g/dL
- Platelet ≥ 100,000/mm\^3 Note: Transfusions or growth factors are not allowed 28 days prior to signing the ICF and continuing through the Screening Period
- Patients must have adequate organ function:
- +30 more criteria
You may not qualify if:
- 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 pregnant or breastfeeding.
- Patients who have active medical illness(es) that would pose increased risk for study participation, including: active systemic infections requiring systemic ABX, coagulation disorders, or other active major medical illnesses of the cardiovascular, respiratory, or immune systems.
- Patients who have received a live or attenuated vaccination within 28 days prior to the start of NMA-LD pre-conditioning regimen.
- Patients who have any form of primary immunodeficiency (such as severe combined immunodeficiency disease \[SCID\] and acquired immunodeficiency syndrome \[AIDS\]).
- Patients who have a left ventricular ejection fraction (LVEF) \<45% or New York Heart Association (NYHA) functional classification \> Class 1.
- Patients ≥ 60 years of age and who have a history of ischemic heart disease, chest pain, or clinically significant atrial and/or ventricular arrhythmias must have a cardiac stress test.
- Patients with any irreversible wall movement abnormalities are excluded.
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexander Shoushtari, MD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 2022
First Posted
November 7, 2022
Study Start
November 1, 2022
Primary Completion
May 1, 2026
Study Completion
May 1, 2026
Last Updated
February 4, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.