Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2, Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (LN-144/LN-145/LN-145-S1) in Patients with Solid Tumors

This study is testing a new way to treat solid tumours, which are cancers that form a lump, like those found in the breast, lung, or bowel. The treatment involves using a patient's own immune cells, called Tumour Infiltrating Lymphocytes (TILs). These special cells are taken from the patient's tumour, grown in a lab to boost their numbers, and then given back to the patient. The main goal is to find out how many patients see their tumours shrink or disappear after this treatment. Researchers will also look at how long the treatment keeps the cancer under control and how long patients live after getting it. This is a Phase 2 study, meaning it's a step closer to becoming a standard treatment if it proves effective and safe.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Iovance Biotherapeutics Inc.

Enrolment target

Start

10 Jun 2024

Neoplasm

What is this study about?

This study is investigating a new treatment for certain solid tumours, which are cancers that form lumps, like those found in organs such as the breast, lung, or bowel. The treatment focuses on using your body's own defence system, called the immune system. Specifically, it uses special immune cells called Tumour Infiltrating Lymphocytes (TILs).

Here's how it generally works: doctors would take a small sample of your tumour. From this sample, they would identify and grow these specific TIL cells in a laboratory, making many more of them. These expanded cells are then given back to you. The idea is that these boosted immune cells will be better equipped to find and destroy the cancer cells throughout your body. You might also receive other medications, like chemotherapy or other immune-boosting drugs, to help prepare your body for the TILs and make them more effective.

This is a 'Phase 2' study, which means researchers are trying to learn more about how well this new treatment works and if it's safe. They are particularly interested in seeing if the treatment can shrink or even make the tumours disappear, and how long these effects last. Understanding these results helps doctors decide if this treatment could become a standard option for patients in the future.

Key takeaways

This study explores using your own immune cells to fight solid tumours.
The treatment involves taking, growing, and returning special cancer-fighting cells.
It's a Phase 2 study, focusing on how well the treatment shrinks tumours and its safety.
Other medications, like chemotherapy or immune boosters, may be part of the treatment.
Participation involves hospital visits and long-term follow-up.

Who may be eligible?

To be considered for this study, you must be an adult, aged 18 years or older. Both men and women are welcome to take part.

Beyond these basic requirements, the study would have more specific criteria related to your type of solid tumour, your overall health, and any previous treatments you've had. These details are very important to make sure the study is right for you and that taking part would be safe.

It's important to discuss your full medical history with your doctor or the study team. They will carefully check if you meet all the necessary conditions to join this research.

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.

Am I 18 years old or older?
Do I have a solid tumour?
Am I able to undergo procedures to remove a piece of my tumour?
Am I prepared for potentially receiving chemotherapy or other immune treatments?
Am I willing to commit to regular hospital visits and follow-up appointments?

Answer every question to see your result.

What does participation involve?

If you join this study, you would first undergo checks to see if this treatment is right for you. This might involve scans and blood tests. If you are suitable, a small part of your tumour would be removed, usually through surgery, so that your special immune cells (TILs) can be grown in a lab. This process can take several weeks.

Before you receive your TILs, you would likely have some chemotherapy or other medication to prepare your body. Then, the grown TIL cells would be given back to you, usually through a drip into your arm. You might also receive other immune-boosting drugs like Aldesleukin, or other medications such as Nivolumab or Ipilimumab, given as injections or infusions. There would be regular hospital visits for check-ups, blood tests, and scans to see how you are responding to the treatment and to monitor your health.

The exact number of visits and the full duration of your participation would depend on your individual response and the specific part of the study you are in, but it would involve a commitment to ongoing medical appointments and follow-up.

Potential risks and benefits

Taking part in a study like this could offer a chance to try a new treatment that isn't yet widely available, and it might help control your cancer. However, this is a new treatment, so there's a chance it might not work for everyone, and it could have side effects. These side effects could range from mild to serious, similar to those seen with chemotherapy or other immune treatments, and your doctors would monitor you very closely. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Spain
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Unverified
Germany
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Unverified
Greece

Common questions

What is a 'solid tumour'?

A solid tumour is a mass of abnormal cells that forms a lump, like breast cancer, lung cancer, or colon cancer, as opposed to blood cancers like leukaemia.

What are TILs?

TILs (Tumour Infiltrating Lymphocytes) are immune cells found inside a tumour. In this study, they are boosted in number outside your body to help fight the cancer more effectively.

What does 'Phase 2 study' mean?

A Phase 2 study means doctors are looking more closely at how well a new treatment works and its safety in a larger group of people, after earlier stages showed it might be effective.

Will I have to stay in the hospital?

You might need to stay in the hospital for some parts of the treatment, especially when receiving the TIL cells and any chemotherapy, due to close monitoring requirements.

Are there other drugs involved in this treatment?

Yes, you might receive other medications like chemotherapy (e.g., Fludarabine, Cyclophosphamide) or other immune-boosting drugs (e.g., Aldesleukin, Nivolumab, Ipilimumab) alongside the TIL cells.