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Study of LN-144 and LN-145 (Tumor Infiltrating Lymphocytes) in patients with solid tumors, including melanoma, head and neck cancer, and non-small cell lung cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial investigates the use of tumor-infiltrating lymphocytes (TIL) therapy for patients with solid tumors. The study tests two investigational products called LN-144 and LN-145, which are made from a patient's own immune cells, in combination with other cancer medications. The main cancer types being studied are melanoma, head and neck squamous cell carcinoma, and non-small cell lung cancer.

The treatment involves several medications given through intravenous infusion. These include the TIL therapy along with nivolumab, ipilimumab, pembrolizumab, fludarabine, cyclophosphamide, and aldesleukin. The TIL therapy is created by taking immune cells from a patient's tumor tissue, growing them in a laboratory, and then giving them back to the patient to help fight the cancer.

The study aims to determine if this combination of treatments is safe and effective for treating these types of cancer. Researchers will measure how many patients' tumors respond to the treatment and track any side effects that occur. The study will also look at how long patients survive without their cancer getting worse and their overall survival time.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial tumor removal

    A surgical procedure will be performed to remove tumor tissue (at least 1.5 cm in diameter) for creating personalized treatment

    You must still have measurable disease after this tumor removal

  2. Step 2

    Preparation phase

    Your medical team will verify that you meet the required health parameters:

    • Blood cell counts must be at specific levels

    • Liver and kidney function must be within acceptable ranges

    • You must be free from active infections

    • Previous treatment side effects must have improved to mild level or less

  3. Step 3

    Treatment administration

    You will receive various medications through intravenous (into the vein) administration:

    • Fludarabine phosphate and cyclophosphamide as preparation medications

    • Tumor-infiltrating lymphocytes (your processed immune cells)

    • Aldesleukin to support the immune cell treatment

    Depending on your assigned treatment group, you may also receive:

    • Pembrolizumab, or

    • Nivolumab with ipilimumab

  4. Step 4

    Monitoring period

    Regular medical assessments will track your response to treatment

    Your doctor will measure if tumors are responding using special criteria called RECIST 1.1

    Side effects will be monitored and recorded

    You must use effective birth control during treatment and for up to 12 months after the last dose

  5. Step 5

    Long-term follow-up

    Your health status will continue to be monitored after treatment completion

    The study will track how long any positive effects last

    Overall survival will be monitored

Who can join the trial?

13 criteria

  • You must have a confirmed diagnosis of one of these conditions: - Stage IIIC to IV melanoma that cannot be surgically removed or has spread - Advanced or spreading head and neck cancer - Stage III or IV lung cancer
  • Your organs must function adequately, including: - Liver function tests within specified limits - Kidney function showing adequate filtration rate - Normal bilirubin levels (a substance that indicates liver function)
  • You must not have any active infections requiring treatment
  • You must be at least 18 years old when giving consent
  • You must have a good level of physical function (ECOG status of 0 or 1, meaning you can perform daily activities)
  • You must have at least one tumor that can be surgically removed (minimum 1.5 cm in size) for treatment preparation
  • You must have additional measurable tumors after the surgical removal
  • Your blood tests must show: - Adequate white blood cell count - Hemoglobin level of at least 8.0 g/dL - Platelet count of at least 100,000/mm3
  • You must have recovered from side effects of previous cancer treatments to mild or no symptoms
  • You must be willing to use effective birth control during treatment and for up to 12 months after treatment completion
  • You must be able to understand and sign the informed consent form
  • You must be willing to share your protected health information
  • Your doctor must expect you to live for at least 6 months

Who cannot join the trial?

15 criteria

  • Active or untreated brain metastases (cancer that has spread to the brain)
  • Severe heart conditions including uncontrolled heart failure or recent heart attack (within past 6 months)
  • Active autoimmune disease requiring systemic treatment (conditions where the immune system attacks healthy cells)
  • Current active infections including hepatitis B, hepatitis C, or HIV
  • Previous organ transplant requiring immunosuppressive therapy (medications that lower immune system function)
  • Pregnant or breastfeeding women
  • Unable to undergo required imaging procedures
  • Psychiatric conditions that could interfere with study compliance
  • Life expectancy less than 3 months
  • Previous treatment with similar cell therapy within the last 6 months
  • Current participation in other clinical trials
  • Severe lung disease affecting breathing capacity
  • Uncontrolled high blood pressure
  • History of severe allergic reactions to study medications
  • Inadequate organ function based on laboratory tests
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Investigated drugs

LN-144 is a personalized cell therapy made from a patient's own tumor-infiltrating lymphocytes (TIL). These are special immune cells that are extracted from the patient's tumor, grown in a laboratory, and then given back to the patient to help fight cancer. LN-145 is another form of personalized cell therapy using tumor-infiltrating lymphocytes. Like LN-144, it is made from the patient's own immune cells that are found within their tumor tissue. LN-145-S1 is a variant of the tumor-infiltrating lymphocyte therapy, also created from a patient's own immune cells extracted from their tumor tissue. These cell therapies are being studied both alone and in combination with checkpoint inhibitors, which are medications that help the immune system recognize and attack cancer cells. The treatments are being tested in patients with melanoma (skin cancer), head and neck cancer (HNSCC), and non-small cell lung cancer (NSCLC).

What is already known about the treatment

  • Tumor Infiltrating Lymphocytes (TIL)

    A personalized cell therapy administered through infusion, where a patient's own immune cells (lymphocytes) are harvested from their tumor tissue, expanded in the laboratory, and then reinfused back into the patient. This innovative treatment is currently being investigated in clinical trials for various solid tumors, particularly melanoma, head and neck squamous cell carcinoma (HNSCC), and non-small cell lung cancer (NSCLC). TIL therapy works by enhancing the body's natural immune response against cancer cells, as these lymphocytes are specifically selected for their ability to recognize and attack tumor cells. It belongs to the class of adoptive cell therapies and represents a promising approach in personalized cancer immunotherapy.

  • Checkpoint Inhibitors (CPIs)

    A class of immunotherapy drugs administered intravenously that work by blocking specific proteins that prevent T-cells from attacking cancer cells. These medications are currently approved and widely used in cancer treatment, particularly for melanoma, lung cancer, and head and neck cancers. They function by releasing the "brakes" on the immune system, allowing it to more effectively recognize and destroy cancer cells. CPIs belong to the broader category of immunotherapy agents and have revolutionized cancer treatment by showing significant efficacy in multiple types of advanced cancers.

Investigated diseases

  • Melanoma

    A type of skin cancer that develops from melanocytes, the cells that produce melanin pigment. It typically begins as a new, unusual-looking spot on the skin or develops from an existing mole, and can spread to other parts of the body. The condition often shows changes in size, shape, or color of skin spots over time.

  • Head and Neck Squamous Cell Carcinoma (HNSCC)

    A cancer that begins in the squamous cells that line the moist surfaces inside the head and neck area. It can affect various areas including the mouth, throat, larynx, and nasal cavity. The condition typically develops gradually and may present as persistent sores or lumps in the affected areas.

  • Non-Small Cell Lung Cancer (NSCLC)

    A common form of lung cancer that develops in the cells lining the lungs. It grows and spreads more slowly than small cell lung cancer. The condition begins in the outer parts of the lungs and gradually affects lung function as it progresses.

  • Neoplasm

    An abnormal growth of tissue resulting from rapid division of cells that have undergone some form of mutation. These growths can be benign or malignant, and can occur in virtually any part of the body. The condition develops when normal cell growth and division processes become disrupted, leading to the formation of masses or tumors.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-510779-39-00Protocol codeIOV-COM-202Estimated enrolment268 patientsSponsorIovance Biotherapeutics Inc.

sourced from the EU Clinical Trials Register and site verification

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