Study of Autologous Tumor-Infiltrating Lymphocytes with Cyclophosphamide, Fludarabine and Aldesleukin in Patients with Germ Cell Tumors

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What is this study about?

This study is looking at germ cell tumors that have not responded to previous chemotherapy treatments. Germ cell tumors are a type of cancer that can develop in various parts of the body, often in the reproductive organs or other areas. The study will use a treatment called autologous tumor-infiltrating lymphocytes, which involves taking immune cells from the patient’s own tumor, growing them in a laboratory, and then giving them back to the patient through an infusion into the vein. Before receiving these cells, patients will receive preparatory treatments including cyclophosphamide and fludarabine phosphate, which are chemotherapy medicines given through the vein. After the infusion of the tumor-infiltrating lymphocytes, patients will also receive aldesleukin, which is a medicine that helps support the immune system.

The purpose of this study is to evaluate how well this treatment with tumor-infiltrating lymphocytes works in patients with germ cell tumors that have not responded to previous treatments. The study will look at whether the tumors shrink, disappear, or stop growing, and will also measure certain substances in the blood called tumor markers that indicate cancer activity.

During the study, a piece of tumor tissue will first be removed from the patient through surgery or by taking small samples called biopsies. This tumor tissue will be used to grow the patient’s own immune cells in the laboratory. Once enough cells have been grown, the patient will receive the preparatory chemotherapy medicines, followed by the infusion of the grown immune cells, and then the immune-supporting medicine. The study will monitor patients for side effects and will regularly check the status of their tumors using imaging scans and blood tests to measure tumor markers and overall health.

1 Tumor removal or biopsy

A tumor sample will be collected from your body to produce the treatment. This sample must be at least 1.5 centimeters in diameter after removal.

If complete tumor removal is not possible, at least 6 small tissue samples will be collected through a procedure called core-biopsy.

If the tumor is located in an area that was previously treated with radiation, it must show signs of growth before the sample is taken.

The tissue sample will be used to create the autologous tumor-infiltrating lymphocytes, which are immune cells taken from your own tumor.

2 Preparation period

After the tumor sample is collected, a waiting period is required before starting the treatment. This period varies depending on your previous treatments.

If you received chemotherapy, at least 14 days must pass before starting the treatment.

If you received immunotherapy, other antibody treatments, or vaccines, at least 21 days must pass, and disease progression must be confirmed.

If you had radiation therapy, all side effects must be resolved to a minimal level, except for hair loss or skin color changes.

If you had surgery, at least 14 days must pass for major procedures, and your wounds must be fully healed.

Any side effects from previous cancer treatments must be resolved to a minimal level before starting this treatment.

3 Pre-treatment chemotherapy

You will receive two chemotherapy medications to prepare your body for the immune cell treatment. This is called non-myeloablative lymphodepleting chemotherapy.

The first medication is cyclophosphamide, which will be given through a vein in your arm.

The second medication is fludarabine phosphate, which will also be given through a vein in your arm.

These medications help create space in your immune system for the new treatment to work effectively.

4 Infusion of tumor-infiltrating lymphocytes

You will receive an infusion of autologous tumor-infiltrating lymphocytes. These are immune cells that were grown from your own tumor tissue.

The cells will be given to you through a vein in your arm as a single treatment.

This product is specifically called VHIO-TIL-01 and is the main investigational treatment in this study.

5 Supportive treatment with aldesleukin

You will receive aldesleukin, also known as IL-2, through a vein in your arm.

This medication helps the infused immune cells survive and function in your body.

The specific dosage, frequency, and duration will be determined by your medical team based on the study protocol.

6 Monitoring and follow-up assessments

Your medical team will monitor you regularly for side effects and to assess how the treatment is working.

Blood tests will be performed to check your tumor markers, which include alpha-fetoprotein, beta-human chorionic gonadotropin, and lactate dehydrogenase.

Imaging scans will be performed to measure changes in your tumor size according to RECIST version 1.1 criteria, which is a standard method for evaluating tumor response.

Side effects will be assessed using the Common Terminology Criteria for Adverse Events version 5.0, which is a standard scale for measuring the severity of side effects.

Your response to treatment will be evaluated to determine if your tumors have shrunk, remained stable, or grown.

Follow-up assessments will continue to track your overall survival and how long you remain without disease progression.

7 Post-treatment period

If you are of childbearing potential or have a partner of childbearing potential, you must use highly effective birth control during treatment and for 12 months after receiving all treatment.

Males may not donate sperm, and females may not donate eggs during the study or for 12 months after treatment ends.

Your medical team will continue to monitor your health status and collect information about your response to treatment and any side effects you experience.

The overall study is expected to continue until December 2029, though your individual participation timeline will be determined by your medical team.

Who Can Join the Study?

You must have a confirmed diagnosis of advanced germ cell tumors, which are cancers that develop from reproductive cells, and these tumors have not responded to additional chemotherapy treatments after the first treatment failed
You must wait a specific amount of time after your last cancer treatment before starting this study: at least 14 days after chemotherapy, which is drug treatment for cancer; at least 21 days after immunotherapy, which is treatment that helps your immune system fight cancer, or other antibody treatments or vaccines; radiation therapy is allowed if all side effects have improved to mild or gone away except for hair loss or skin color changes; surgery is allowed if your wounds have healed and at least 14 days have passed for major operations
You must have recovered from side effects of previous cancer treatments to mild or none, except for hair loss or changes in skin color
If you have ongoing moderate or worse side effects from previous cancer treatment, your case may be reviewed individually by the study doctor
You must sign a form allowing the use of your health information for the study
You must be able to understand the study requirements and agree to participate by signing a consent form, which is a document showing you agree to join the study, and you must be able to attend all required study visits
You must be 18 years of age or older
You must have at least one tumor that can be surgically removed that is at least 1.5 centimeters in size, or at least 6 small tissue samples can be taken from your tumor to create the treatment; if the tumor is in an area that was previously treated with radiation, it must have grown since the radiation treatment; you must have enough tissue available for required testing
You must have evidence that your germ cell tumor has grown or returned after receiving two rounds of platinum-based chemotherapy, which is a specific type of cancer drug treatment, shown by one of the following: a tissue sample showing active cancer cells that are not a specific type called teratoma, or increasing levels of cancer markers in your blood called B-hCG or FP, which are proteins that indicate tumor activity, or new or growing tumors with high levels of these cancer markers
You must have an ECOG performance status of 0 or 1, which is a scale measuring how well you can perform daily activities where 0 means fully active and 1 means some restrictions, and your doctor must estimate you will live at least 3 months
If you or your partner can have children, you must use highly effective birth control methods during treatment and for 12 months after completing therapy; men cannot donate sperm and women cannot donate eggs during the study and for 12 months after treatment; acceptable birth control methods include hormonal contraceptives in various forms, intrauterine devices, tubal ligation, vasectomy, or complete abstinence if this is your usual lifestyle
You must have adequate blood cell counts: absolute neutrophil count, which measures infection-fighting white blood cells, must be at least 1 times 10 to the power of 9 per liter; hemoglobin, which carries oxygen in your blood, must be at least 9.0 grams per deciliter; platelet count, which helps blood clot, must be at least 100 times 10 to the power of 9 per liter
You must have adequate organ function: liver enzymes called ALT and AST must be no more than 3 times the normal upper limit, or no more than 5 times if you have cancer spread to your liver; your kidney function measured by creatinine clearance must be at least 40 milliliters per minute; total bilirubin, which measures liver function, must be no more than 2 milligrams per deciliter, or no more than 3 if you have a condition called Gilbert’s Syndrome
You must test negative for HIV, which is the virus that causes AIDS; if you test positive for hepatitis B or hepatitis C viruses, which affect the liver, you may still participate if the virus is undetectable in your blood with or without treatment

Who Cannot Join the Study?

The study does not list specific reasons why patients cannot participate in this clinical trial in the available information
If you are interested in this study, the research team will need to review your complete medical history to determine if you meet all the requirements for participation
General factors that often prevent participation in cancer studies may include having other serious medical conditions, being pregnant or breastfeeding, or having certain blood test results that are outside the safe range
The study involves using your own immune cells, which are special cells from your body that fight disease, so the research team will need to make sure your body can safely undergo the procedures needed to collect and receive these cells

Where you can join this trial?

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Other Sites

Site Name	City	Country
Hospital Universitario 12 De Octubre	Madrid	Spain
Imqvndbi Csscdg Dtbbaqrfshqdrnbzi	L'hospitalet De Llobregat	Spain
Hvhfkwdy Vtvq dauzepsc	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not yet recruiting	01.08.2025

Trial locations

Investigated drugs:

VHIO-TIL-01 is a personalized treatment made from your own immune cells called tumor-infiltrating lymphocytes, or TILs. These are special white blood cells that are taken from your tumor tissue, grown in large numbers in a laboratory, and then given back to you through an infusion into your vein. The goal is to help your immune system better recognize and fight the cancer cells in your body.

Germ Cell Tumors – Germ cell tumors are cancers that develop from the cells that are meant to become eggs in females or sperm in males. These tumors can occur in the reproductive organs but may also appear in other parts of the body, such as the brain, chest, or abdomen. The disease can affect people of various ages, though it is most common in young adults and children. When germ cell tumors are described as refractory to salvage chemotherapy, it means they have not responded to additional rounds of drug treatment given after initial therapy failed. The tumors may continue to grow or spread despite multiple attempts at treatment with different chemotherapy combinations. Tumor markers such as AFP, bHCG, and LDH are often elevated in the blood and help monitor disease activity.

Trial ID:

2025-522427-10-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Autologous Tumor-Infiltrating Lymphocytes with Cyclophosphamide, Fludarabine and Aldesleukin in Patients with Germ Cell Tumors

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?