Oncolytic virus TILT-123 in combination with lymphocyte-depleting chemotherapy and TILs in the treatment of melanoma
Melanoma is a serious type of skin cancer. When standard treatments no longer work well, researchers look for new ways to help the immune system fight the cancer. This Phase 1 trial tests a new treatment approach that combines three elements: an altered virus called TILT-123, mild chemotherapy, and tumour-infiltrating lymphocytes (TILs). TILT-123 is a virus engineered to attack cancer cells and call in the body's natural defences. TILs are immune cells taken from the patient's own tumour, grown in large numbers in a specialist lab, and then given back through a drip. Chemotherapy is used first to clear space in the body so the new immune cells can work better. Because this is a Phase 1 study, the main goal is to see if this combination is safe and to find the right dosage for future research.
At a glance
What is this study about?
Melanoma is an aggressive form of skin cancer that can sometimes spread to other parts of the body. While modern therapies have helped many people, melanoma can become resistant to standard options. When this happens, doctors need innovative strategies. This clinical trial explores a multi-step treatment designed to supercharge the patient's own immune system to target and destroy melanoma cells.
The study uses an experimental treatment known as TILT-123. This is an 'oncolytic virus', which is a common cold-like virus that scientists have modified in a laboratory. It is designed to infect cancer cells without harming healthy tissue. Once inside, it bursts the tumour cell and releases immune signals that draw the body's natural defences straight to the cancer.
Alongside the virus, patients receive TIL therapy. 'TIL' stands for tumour-infiltrating lymphocytes. These are cancer-fighting white blood cells that have already managed to reach the tumour. Doctors collect a sample of these cells from the patient, grow billions more of them in a laboratory, and return them into the bloodstream. Before the cells are returned, a short course of chemotherapy is given to temporarily clear away existing white blood cells, giving the new, lab-grown cells the best chance to survive and multiply.
Because this is a Phase 1 clinical trial, the main priority is safety. The research team wants to understand what side effects occur, how the body handles the treatment, and what the most effective doses might be. While Phase 1 trials are not guaranteed to cure cancer, they provide vital knowledge that shapes the future of cancer care.
Key takeaways
- Phase 1 trial testing a modified virus (TILT-123) combined with chemotherapy and immune cell therapy (TILs).
- Aimed at adults aged 18 and older with melanoma.
- Focuses primarily on checking safety, finding side effects, and testing appropriate doses.
- Requires a hospital stay and a small procedure to collect your immune cells.
- Taking part is entirely voluntary, and you can withdraw at any time.
Who may be eligible?
This trial is open to adults aged 18 and older who have been diagnosed with melanoma. Generally, trials like this are designed for people whose cancer is advanced or has not responded to standard treatments.
To be considered, patients must be well enough to carry out daily tasks and have reasonably healthy heart, kidney, and liver function. Because the trial requires growing immune cells from tumour tissue, patients must also have a tumour that can be safely sampled through a small procedure or biopsy.
People with severe active infections, certain autoimmune diseases, or serious uncontrolled medical conditions may not be able to take part. The trial medical team will carry out detailed blood tests and scans to ensure it is safe for each individual to join.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I am aged 18 or over.
- I have been diagnosed with melanoma.
- My cancer is advanced or standard treatments have not worked.
- I am well enough to attend regular hospital appointments.
- I am willing to undergo tests, a biopsy, and a short hospital stay.
What does participation involve?
Taking part in this study involves several distinct steps over a number of months. First, doctors will perform scans and tests to ensure the trial is safe for you. If eligible, you will have a small surgical procedure to remove a piece of tumour tissue so your immune cells (TILs) can be grown in a laboratory, which takes several weeks.
Once the cells are ready, you will stay in hospital for a short period. You will receive a brief course of chemotherapy via a drip to prepare your body, followed by the TILT-123 virus injections and your lab-grown TIL cells. Afterwards, you will need frequent hospital visits for blood tests, physical checks, and scans so doctors can monitor your recovery and watch for side effects. Long-term follow-up visits will continue for months to monitor your health.
Potential risks and benefits
Locations (1)
- —UnverifiedDenmark
Common questions
What is an oncolytic virus?
It is a virus that has been modified in a lab so it selectively infects and destroys cancer cells while leaving healthy cells alone.
Will I receive a dummy treatment (placebo)?
No. In Phase 1 cancer trials, placebos are rarely used. All participants in this study receive the active treatment.
Do I have to pay to take part in this trial?
No. Clinical trial treatments and extra study tests are provided free of charge, and some travel expenses may be covered.
Will I need to stay overnight in hospital?
Yes. Due to the chemotherapy and cell infusions, you will likely need to stay in hospital for several days so the team can monitor you closely.
What happens if I change my mind after joining?
You can leave the trial at any point, for any reason. Your medical team will simply discuss alternative treatment options with you.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.