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Study of LN-145 (tumor infiltrating lymphocytes) with cyclophosphamide, fludarabine, and aldesleukin in patients with recurrent, metastatic, or persistent cervical 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 focuses on patients with recurrent, metastatic, or persistent cervical carcinoma. The study evaluates a treatment called LN-145, which consists of the patient's own tumor-fighting cells called tumor infiltrating lymphocytes. These cells are removed from the patient's tumor tissue, grown in a laboratory, and then given back to the patient to help fight the cancer.

Before receiving LN-145, patients will be given three preparatory medications: cyclophosphamide, fludarabine phosphate, and aldesleukin. These medications are administered through intravenous infusion to prepare the body for the cell therapy treatment. The study includes different groups of patients, including those who have previously received other cancer treatments and those who haven't.

The main purpose of this study is to determine if LN-145 is effective and safe for treating cervical cancer that has spread or returned after previous treatments. The treatment process involves removing tumor tissue through surgery, processing the tissue in a laboratory to obtain the tumor-fighting cells, and then giving these cells back to the patient through an intravenous infusion.

The research process

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

Step 1
Initial assessment
Your eligibility for the study will be evaluated based on medical tests and history
Laboratory tests will check your blood counts, liver and kidney function
You must be at least 18 years old and have cervical cancer that has returned or spread
Step 2
Tumor tissue collection
A surgical procedure will be performed to remove a portion of your tumor
The tumor sample must be at least 1.5 centimeters in size
The hospital stay for this procedure should not exceed 3 days
Step 3
Preparation phase
You must stop any previous cancer treatments at least 28 days before the tumor removal
Your tumor sample will be used to create your personalized treatment called LN-145
This treatment contains cells called tumor-infiltrating lymphocytes that are taken from your own tumor
Step 4
Treatment administration
You will receive several medications through an intravenous line (into your vein):
- Fludarabine phosphate
- Cyclophosphamide
- Aldesleukin
- Your personalized LN-145 treatment
Step 5
Monitoring period
Your response to the treatment will be evaluated through regular medical examinations
The medical team will monitor any side effects
You will need to use effective birth control during treatment and for 12 months afterward
Regular follow-up visits will continue to track your progress

Who can join the trial?

12 criteria

Must be 18 years or older at the time of consent (patients over 70 require special approval)
Must meet specific blood test requirements including: - Adequate white blood cell count - Hemoglobin levels of at least 8 g/dL - Platelet count of at least 100,000/mm3 - Liver and kidney function tests within acceptable ranges
Must be free from active infections and test negative for HIV. Patients with hepatitis B or C may participate if the virus is undetectable in their blood
If able to become pregnant, must agree to use effective birth control during treatment and for 12 months after the last treatment
Must be able to understand and sign the informed consent form
Must be willing and able to attend all scheduled study visits
Must have cervical cancer that has returned or spread, and cannot be cured with surgery or radiation therapy
Must have at least one tumor that can be surgically removed, measuring at least 1.5 cm
Must have at least one measurable tumor that can be monitored during the study
Must have had previous treatment with chemotherapy (between 1-3 different treatments) that did not stop the cancer from growing
Must wait at least 28 days after any previous cancer treatment before having tumor removal surgery
Must have good physical function, able to carry out light activities (ECOG performance status of 0 or 1)

Who cannot join the trial?

12 criteria

Active brain metastases (cancer that has spread to the brain) or presence of brain lesions requiring ongoing treatment
Presence of active or chronic infections, including HIV, hepatitis B, or hepatitis C
Autoimmune diseases requiring systemic treatment (conditions where the immune system attacks healthy cells)
History of other cancers within the past 3 years, except for successfully treated non-melanoma skin cancer or cervical cancer in situ
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Severe heart conditions, including:
- Unstable angina (chest pain)
- Heart attack within past 6 months
- Severe heart rhythm problems
- Pregnant or breastfeeding women
- Current participation in other clinical trials or treatment with investigational drugs within 28 days before starting this study
- Known allergies or sensitivity to components of the study treatment
- Psychiatric conditions that could interfere with study participation
- Serious uncontrolled medical conditions that could compromise study participation

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Amsterdam UMC
Amsterdam, The Netherlands
Responsive
Hospital Universitario Hm Sanchinarro
Madrid, Spain
Responsive
Istituto Europeo Di Oncologia S.r.l.
Milan, Italy

Trial locations

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Investigated drugs

LN-145 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 and multiplied in a laboratory, and then given back to the patient to help fight their cervical cancer. Pembrolizumab is an immunotherapy medication that helps the immune system fight cancer cells. It works by blocking a protein that can prevent T-cells (immune cells) from attacking cancer cells, allowing the body's immune system to work more effectively against the cancer. These medications were studied both individually and in combination for treating patients with cervical cancer that has either come back after previous treatment, spread to other parts of the body, or continued to persist despite treatment.

What is already known about the treatment

LN-145
A personalized cell therapy consisting of autologous tumor infiltrating lymphocytes (TILs) that are extracted from a patient's own tumor tissue, expanded in the laboratory, and then reinfused back into the patient. This investigational treatment is being studied for recurrent, metastatic, or persistent cervical carcinoma, working by enhancing the body's natural immune response against cancer cells. LN-145 belongs to the class of cellular immunotherapies and is administered through intravenous infusion after a lymphodepletion regimen to prepare the patient's immune system.
Pembrolizumab
An immunotherapy medication administered via intravenous infusion that works by blocking the PD-1 pathway, helping the immune system recognize and attack cancer cells. This FDA-approved medication is being studied in combination with LN-145 for treating recurrent, metastatic, or persistent cervical carcinoma, belonging to the class of checkpoint inhibitors known as PD-1 inhibitors. Pembrolizumab has shown significant efficacy in various types of cancers by reactivating the body's immune response against tumor cells.

Investigated diseases

Cervical Carcinoma - A cancer that develops in the cells of the cervix, which is the lower part of the uterus connecting to the vagina. The disease typically develops slowly over time, starting with precancerous changes in cervical cells. In its recurrent form, the cancer returns after initial treatment, while metastatic means it has spread to other parts of the body beyond its original location. When described as persistent, it means the cancer continues to be present despite previous treatments. The disease can progress from localized cancer affecting only the cervix to more advanced stages where it spreads to nearby tissues or distant organs.