Actively Recruiting
A Study of LN-144 or LN-145 in People With Advanced Uveal Melanoma, Undifferentiated Pleomorphic Sarcoma, or Dedifferentiated Liposarcoma
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-02-04
30
Participants Needed
2
Research Sites
182 weeks
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
I
Iovance Biotherapeutics, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is an open label study evaluating lifileucel (LN-144) in patients with metastatic uveal melanoma.
CONDITIONS
Official Title
A Study of LN-144 or LN-145 in People With Advanced Uveal Melanoma, Undifferentiated Pleomorphic Sarcoma, or Dedifferentiated Liposarcoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Confirmed diagnosis of metastatic uveal melanoma or unresectable/metastatic undifferentiated pleomorphic sarcoma or dedifferentiated liposarcoma refractory to at least 1 prior systemic therapy
- At least one lesion 1.5 cm or larger available for tumor infiltrating lymphocytes harvesting
- At least 18 years old at time of consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Estimated life expectancy of at least 6 months
- Adequate blood counts: absolute neutrophil count ≥1000/mm3, hemoglobin ≥9.0 g/dL, platelet count ≥100,000/mm3 without recent transfusions or growth factors
- Adequate organ function including liver enzymes, creatinine clearance ≥40 mL/min, and bilirubin within specified limits
- Negative tests for HIV, hepatitis B and C, syphilis, cytomegalovirus IgM, Epstein-Barr virus IgM, and herpes simplex virus IgM; those positive for HSV IgM must be treated and become negative
- Asymptomatic from prior COVID-19 infection for more than 30 days
- Completed required washout periods from prior anticancer therapies
- Recovery from prior treatment related adverse events to Grade 1 or less
- Stable immunotherapy-related endocrinopathies controlled for at least 6 weeks
- Wound healing complete from prior surgeries with no complications
- Willingness to use effective birth control during treatment and for 12 months after last IL-2 dose
- Ability to understand study requirements and provide informed consent
You will not qualify if you...
- Previous organ transplant or prior cell transfer therapy with myeloablative chemotherapy
- History of allergy to any components of the study drugs or infusion product
- Symptomatic brain metastases; treated brain metastases must be stable without symptoms or steroids
- Chronic systemic immunosuppressive therapy exceeding 10 mg prednisone equivalent daily
- Pregnancy or breastfeeding
- Active serious medical illnesses including infections, coagulation disorders, or major cardiovascular, respiratory, or immune diseases
- Live or attenuated vaccine within 28 days before lymphodepletion
- Primary immunodeficiency disorders such as SCID or AIDS
- Left ventricular ejection fraction below 45% or advanced heart failure
- Significant pulmonary disease with low lung function or inability to walk required distance without hypoxia
- Active or uncontrolled infections including COVID-19 within 30 days prior to surgery or lymphodepletion
- Participation in another clinical trial with investigational treatment within 21 days
- Other active malignancies requiring systemic therapy or interfering with response evaluation except certain hormone-treated cancers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604
Actively Recruiting
2
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
Research Team
A
Alexander Shoushtari, MD
CONTACT
L
Lauren Banks, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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