A New Treatment Using Your Own Immune Cells to Fight Advanced Uveal Melanoma

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

Memorial Sloan Kettering Cancer CenterPHASE1Recruiting
Check EligibilityDoctor's Note PDF

In Plain English

This trial tests a treatment called lifileucel that uses your body's own immune cells to fight uveal melanoma that has spread. Here's how it works: doctors remove immune cells called TILs (tumor infiltrating lymphocytes) from your tumor—these are cells your body already sent to fight the cancer. The cells are then grown in a lab for about 3 weeks to create millions of copies of your cancer-fighting cells. Then you receive chemotherapy to prepare your body, followed by an infusion of these boosted immune cells back into your bloodstream, plus a short course of a drug called IL-2 that helps these cells work harder. This is an early-stage trial (Phase 1), which means researchers are still learning how well this works and what side effects to expect. You would be one of the first patients to receive this specific treatment. The goal is to give your immune system a powerful, personalized weapon against your cancer—using cells that already know how to recognize and attack your tumor.

What This Trial Does

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

Who Can Join

Translated to plain English

Inclusion Criteria

  • For Cohort 1: You must have been diagnosed with uveal melanoma (a type of eye cancer) that has spread to other parts of your body.
  • You can join this study no matter how many cancer treatments you've received before.
  • For Cohort 2: You must have been diagnosed with undifferentiated pleomorphic sarcoma (UPS) or dedifferentiated liposarcoma (DDLPS) that cannot be surgically removed or has spread, and it did not respond to at least one previous cancer treatment.
  • Your cancer is considered unresectable if a sarcoma surgeon determines that removing it completely would be very difficult or would cause too much harm to your body.
  • Any cancer treatment you received before surgery or after surgery to prevent cancer from returning counts as a prior treatment.
  • You can participate even if you choose not to receive standard chemotherapy.
  • You must have at least one tumor that is at least 1.5 cm in size that hasn't been treated with embolization (blocking blood flow) or radiation in the last 3 months, unless the tumor has grown by at least 0.5 cm since then.
  • You must be at least 18 years old when you sign up for the study.
  • You must be in good enough health to carry out daily activities with little or no assistance (ECOG score of 0 or 1).
  • Your doctor must believe you will likely live for at least 6 more months.
  • Your blood cell counts must be in a healthy range.
  • Your absolute neutrophil count (a type of white blood cell that fights infection) must be at least 1000 cells per cubic millimeter of blood.
  • Your hemoglobin (the protein in red blood cells that carries oxygen) must be at least 9.0 grams per deciliter of blood.
  • Your platelet count (cells that help blood clot) must be at least 100,000 per cubic millimeter of blood, and you cannot receive blood transfusions or growth factor medications for 28 days before signing the consent form and during the screening period.
  • Your liver, kidneys, and heart must be working well enough to safely participate in the study.
  • Your liver enzyme levels (ALT and AST) must be no more than 3 times the normal upper limit; if you have cancer that has spread to your liver, they can be up to 5 times the normal upper limit.
  • Your kidneys must be filtering waste adequately, with an estimated creatinine clearance of at least 40 mL/min based on a calculation done at the screening visit.
  • Your total bilirubin (a substance made by your liver) must be 2 mg/dL or lower.
  • If you have Gilbert's syndrome (a harmless genetic condition affecting bilirubin), your total bilirubin can be up to 3 mg/dL.
  • You must test negative for certain infections, as listed below.
  • You must test negative for HIV-1 or HIV-2 (the viruses that cause AIDS).
  • You must test negative for hepatitis B and hepatitis C; however, if you have hepatitis B or C, you can still join if your viral load (amount of virus) is undetectable by PCR testing, whether or not you're receiving treatment.
  • You must test negative for syphilis using a blood test (RPR or VDRL).
  • You must test negative for active CMV (cytomegalovirus) and EBV (Epstein-Barr virus) infections based on antibody or PCR testing.
  • You must test negative for active HSV-1 and HSV-2 (herpes simplex viruses) based on antibody or PCR testing.
  • If you test positive for HSV on IgM antibody or PCR testing, you must receive treatment and become negative before starting the study's pre-conditioning regimen.
  • If you've had COVID-19, you must have no symptoms for more than 30 days before starting the study treatment.
  • You must wait a certain amount of time after stopping previous cancer treatments before starting this study, as detailed in the criteria below.
  • If you've taken targeted cancer drugs (like erlotinib, osimertinib, or crizotinib), you must wait at least 14 days or 5 half-lives of the drug (whichever is longer) before starting this study.
  • If you've had chemotherapy, you must wait at least 21 days before starting this study.
  • You can have received previous immunotherapy treatments (like checkpoint inhibitors or cancer vaccines) as long as you stop taking them at least 21 days before starting this study.
  • You can receive radiation therapy to help with symptoms, but it cannot be used on the tumors being studied for this trial, and any side effects must be mild (Grade 1 or less) before starting treatment.
  • You must have recovered from side effects of all previous cancer treatments to mild levels (Grade 1 or less), except for hair loss or skin discoloration, before joining the study.
  • If you had severe diarrhea or colon inflammation from previous immunotherapy, you must have had no symptoms for at least 6 months and/or a normal colonoscopy before starting this study.
  • You can have hormone-related side effects from previous immunotherapy (like low thyroid function) as long as they have been stable for at least 6 weeks and are controlled with hormone replacement therapy.
  • You can have had previous surgeries as long as your wounds have fully healed, any complications are gone, and at least 14 days have passed since major surgery before starting treatment.
  • If you can become pregnant or could father a child, you must use an effective birth control method during the study and for 12 months after your last dose of IL-2 (a study drug).
  • Birth control options include combination pills, patches, or rings that contain both estrogen and progesterone to prevent ovulation.
  • Birth control options include progesterone-only pills, shots, or implants that prevent ovulation.
  • An intrauterine device (IUD) is a small device placed in the uterus to prevent pregnancy.
  • An intrauterine hormone-releasing system (IUS) is a device placed in the uterus that releases hormones to prevent pregnancy.
  • Permanent surgical blocking of the fallopian tubes is an approved birth control method.
  • Having a partner who has had a vasectomy (surgical sterilization) is an approved birth control method.
  • Complete sexual abstinence is acceptable only if it matches your normal lifestyle; using methods like tracking your cycle is not acceptable.
  • You must understand the study requirements, sign a consent form approved by an ethics board, and agree to follow all study rules and attend all required visits, including follow-up appointments after the study ends.

Exclusion Criteria

  • You cannot be in this study if you've had an organ transplant or received a cell transfer treatment that involved strong chemotherapy drugs designed to suppress your bone marrow.
  • You cannot participate if you've had an allergic reaction to any ingredient in the study drugs LN-144/LN-145 or other medications used in this trial.
  • This is the pre-treatment chemotherapy regimen you'll receive, which includes three drugs: cyclophosphamide, mesna, and fludarabine.
  • You cannot be in this study if you're allergic to Proleukin (also called aldesleukin or IL-2), a drug that boosts immune cells.
  • You cannot take certain antibiotics called aminoglycosides (like streptomycin or gentamicin), unless you've had a skin test showing you're not allergic to gentamicin.
  • You cannot be in this study if you're allergic to any ingredient in the study cell infusion product, including DMSO, human serum albumin, IL-2, or dextran-40.
  • You cannot participate if you have brain tumors that are causing symptoms like headaches, vision problems, or neurological issues.
  • If you've had brain tumors surgically removed before the study, you may still qualify if you're stable for at least 14 days after surgery, have no active symptoms, and don't need ongoing steroid treatment.
  • You cannot be on long-term immune-suppressing medications, except you can take up to 10 mg daily of prednisone (or equivalent) if needed for adrenal insufficiency; short-term steroid use around surgery is allowed.
  • You cannot participate if you are pregnant or breastfeeding.
  • You cannot be in this study if you have active infections requiring antibiotics, blood clotting problems, or serious heart, lung, or immune system diseases.
  • You cannot have received a live or weakened vaccine within 28 days before starting the pre-treatment chemotherapy.
  • You cannot participate if you have a primary immune deficiency disorder (like SCID) or AIDS.
  • You cannot be in this study if your heart's pumping strength is below 45% or if you have significant heart function limitations classified as worse than Class 1 by the New York Heart Association.
  • If you're 60 or older and have a history of heart disease, chest pain, or irregular heartbeats, you must pass a cardiac stress test before enrolling.
  • You cannot be in this study if you have permanent damage to your heart's ability to pump blood normally.
  • You cannot be in this study if you smoke or have lung disease (like asthma or emphysema) and your lung function test shows you can only breathe out 60% or less of the normal amount of air in one second.
  • If you cannot do a standard lung function test because of an unusual airway (like a tracheostomy), doctors can do a 6-minute walk test instead to check your lung health.
  • You cannot be in this study if you cannot walk at least 80% of the distance expected for your age and sex, or if your oxygen level drops below 90% during the walk test.
  • You cannot be in this study if you have an active, uncontrolled infection (including COVID-19) within 30 days before surgery or treatment, though a simple urinary tract infection that has been successfully treated is allowed.
  • You cannot be in this study if you are currently in another research study testing an experimental drug or treatment within the last 21 days.
  • You cannot be in this study if you have another active cancer that needs ongoing treatment, unless it's a slow-growing cancer like some prostate cancers being treated with hormone therapy and your doctor approves.
  • This section describes who is eligible to receive the lymphodepletion treatment (a process that reduces certain immune cells).
  • You will be enrolled in the main treatment part of the study if you meet all eligibility requirements between 21 and 8 days before your scheduled treatment starts.
  • Before your lymphodepletion treatment, all your eligibility requirements will be checked again within a few days, including repeating heart and lung function tests if needed.
  • Before you start the lymphodepletion treatment, certain medical requirements must be completed.
  • You must meet all eligibility requirements at the time you start the lymphodepletion treatment.
  • Any active infection you have must be completely gone before you start lymphodepletion treatment.
  • Doctors must document and carefully review any new or worsening problems with your heart, lungs, kidneys, blood clotting, immune system, or other serious health conditions.
  • If you have fluid building up around your lungs that causes symptoms and keeps coming back, you cannot start lymphodepletion treatment unless a temporary drain is placed first.
  • Your doctor needs to make sure all your current health problems are being treated properly, and you may need additional scans or tests to confirm everything is under control.
  • Your doctor will continuously weigh whether the benefits of this treatment outweigh the risks, and can stop or delay any part of the treatment (the chemotherapy preparation, the cell infusion, or the immune-boosting drug) if they believe the risks become too high for you.
  • If the treatment start date gets pushed back by up to 14 days because of production delays or bad weather, this won't be considered a protocol violation, and you won't need to repeat screening tests unless your health condition changes.
Age: 18 Years+

Treatments

Lifileucel (LN-144/LN-145) (BIOLOGICAL)

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.

Trial Sites (2)

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Memorial Sloan Kettering Westchester

Harrison, New York, United States

Alexander Shoushtari, MD

Recruiting

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Alexander Shoushtari, MD

Recruiting