Actively Recruiting
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
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-05-28
30
Participants Needed
2
Research Sites
N/A
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
Researchers are evaluating lifileucel (LN-144/LN-145), an autologous tumor infiltrating lymphocyte (TIL) cell therapy, in patients with advanced metastatic uveal melanoma, undifferentiated pleomorphic sarcoma, or dedifferentiated liposarcoma. This open-label phase 1 trial focuses on patients with these advanced cancers who often have limited treatment options. The study is sponsored by Memorial Sloan Kettering Cancer Center and aims to assess the safety of this cell therapy in these patient groups. Participants will undergo surgical removal of tumor tissue to generate the personalized lifileucel treatment through a 22-day centralized process. The treatment involves preparative non-myeloablative lymphodepleting chemotherapy, a one-time infusion of the autologous TIL product, and a short course of high-dose interleukin-2 (IL-2). The study includes separate groups for patients with metastatic uveal melanoma and those with metastatic sarcoma. Treatment timelines include a screening period, surgery for tumor harvesting, cell manufacturing, and subsequent lymphodepletion and infusion. Throughout the study, participants will be closely monitored for adverse events using standardized criteria over up to three years. Assessments include regular clinical evaluations, laboratory tests, and imaging to monitor safety and disease status. Patients must meet specific health and organ function requirements before treatment, and they will be followed during and after treatment to evaluate safety signals and overall health. The total participation duration varies, including the treatment phase and extended follow-up periods.
CONDITIONS
Brief 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 (Cohort 1) or unresectable/metastatic undifferentiated pleomorphic sarcoma or dedifferentiated liposarcoma refractory to at least one prior systemic therapy (Cohort 2)
- At least one tumor lesion 1.5 cm or larger suitable for TIL harvesting that has not undergone embolization or radiation in the prior 3 months unless growth is shown
- Age 18 years or older at time of consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Estimated life expectancy of 6 months or more
- Adequate blood counts: ANC ≥1000/mm3, hemoglobin ≥9.0 g/dL, platelets ≥100,000/mm3 without recent transfusions or growth factors
- Adequate organ function: liver enzymes ≤3x ULN (≤5x ULN with liver metastasis), creatinine clearance ≥40 mL/min, bilirubin ≤2 mg/dL (≤3 mg/dL if Gilbert's syndrome)
- Negative for HIV, hepatitis B and C, syphilis, active CMV, EBV, and HSV infections; prior infections must be treated and resolved before treatment
- Asymptomatic from prior COVID-19 infection for more than 30 days before lymphodepletion
- Completed required washout periods from prior targeted therapy, chemotherapy, or immunotherapy
- Recovered from prior anti-cancer therapy adverse events to grade 1 or less (except alopecia or vitiligo)
- Stable immunotherapy-related endocrinopathies and no recent severe immune-related colitis
- Recovered from prior surgeries with at least 14 days elapsed for major operations
- Willingness to use effective birth control during treatment and for 12 months after last IL-2 dose
- Ability to understand and consent to study requirements and comply with visits and assessments
You will not qualify if you...
- Prior organ transplant or prior cell transfer therapy with myeloablative chemotherapy
- Hypersensitivity to components of LN-144/LN-145, lymphodepletion drugs, IL-2, or related antibiotics
- Symptomatic brain metastases; stable, treated brain metastases allowed if stable for at least 14 days without steroids
- Chronic systemic immunosuppressive therapy above 10 mg prednisone equivalent daily, except for adrenal insufficiency management
- Pregnant or breastfeeding
- Active major medical illnesses including infections requiring systemic antibiotics, coagulation disorders, or major cardiovascular, respiratory, or immune disease
- Live or attenuated vaccine within 28 days before lymphodepletion
- Primary immunodeficiency disorders including SCID or AIDS
- Left ventricular ejection fraction below 45% or significant cardiac arrhythmias or wall motion abnormalities
- Significant pulmonary disease with forced expiratory volume ≤60% predicted or inability to walk required distances without hypoxia
- Active uncontrolled infections including COVID-19 within 30 days before surgery or lymphodepletion
- Participation in another investigational study within 21 days before lymphodepletion
- Other active cancers requiring systemic treatment or interfering with response assessment, except certain hormone-treated cancers with no evidence of disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 22 days
Participants undergo surgical excision to generate the autologous tumor infiltrating lymphocytes (LN-144 or LN-145) used for treatment.
1 surgical procedure
Duration - Short course consistent with treatment regimen
Participants receive preparative non-myeloablative lymphodepletion, followed by a one-time infusion of LN-144 or LN-145 and a short course of high-dose IL-2.
1 treatment infusion and several inpatient visits for IL-2 administration
Duration - Up to 3 years
Participants are monitored for safety and adverse events for up to 3 years after treatment.
Regular follow-up visits as scheduled by the study team
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
L
Lauren Banks, MD, PhD
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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