RecruitingPHASE1, PHASE2INTERVENTIONAL

LEU01101: Safety and Preliminary Efficacy of LEU011 in Solid Tumours.

This research study, called LEU01101, is investigating a new treatment named LEU011 for solid tumours. These are cancers that form solid lumps in the body. The study is particularly looking at people whose cancer hasn't improved with other standard treatments or for whom other treatments aren't suitable. This is an early-stage trial (Phase 1/2a), which means the main goals are to check how safe LEU011 is, how well people tolerate it, and to find the right dose. Participants will first have some chemotherapy, then receive a single infusion of LEU011, and be monitored for up to two years. The treatment involves using some of the patient's own cells, which are specially modified in the lab.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

Leucid Bio

Enrolment target

Start

13 Nov 2023

Estimated completion

01 May 2029

Tumor, Solid

What is this study about?

This research study, named LEU01101, is focused on finding new ways to treat solid tumours. Solid tumours are cancers that form solid masses in different parts of the body, unlike blood cancers. For many patients, standard treatments work well, but sometimes cancer can come back or not respond to these treatments, leaving limited options. This study aims to explore a new treatment called LEU011, which uses a person's own immune cells, known as T-cells, to fight cancer.

LEU011 is a type of immunotherapy. This means it helps your own body's defence system (your immune system) to recognise and attack cancer cells. In this case, doctors will take some of your blood, specially train particular cells from it (called CAR T-cells) to target certain markers on cancer cells (NKG2D ligands), and then give these specially trained cells back to you. The hope is that these re-engineered cells will then seek out and destroy the cancer cells.

Because LEU011 is a new treatment, this is an early-stage study (Phase 1/2a). This first stage is crucial for understanding how safe the treatment is, what side effects it might cause, and to find the best dose. Doctors will be very carefully monitoring participants to ensure their well-being throughout the trial. It's a stepping stone towards potentially making new treatments available in the future.

Key takeaways

This study is testing a new immune cell therapy for solid tumours.
It's an early-stage trial focused on safety and finding the right dose.
The treatment uses your own specially modified immune cells.
Participants will receive chemotherapy before a single treatment infusion.
You'll be closely monitored for up to two years, with longer-term follow-up.

Who may be eligible?

To be considered for this study, you must have a solid tumour that has been confirmed by doctors through tests. You need to be 18 years old or older. Importantly, your cancer should have returned or not responded to previous treatments, and there shouldn't be any other standard treatment options currently available or suitable for you.

Your tumour must also show certain markers, called NKG2DL proteins, which the new treatment is designed to target. Doctors will check for this during screening. Your general health also needs to be good enough to take part; this means having good heart and lung function, and your blood and kidney tests need to be within a healthy range. You should also be able to undergo a biopsy if needed and be expected to live for at least six months.

However, some conditions would mean you couldn't join the study. For example, if you have certain active infections like HIV or active Hepatitis B or C. All potential participants will have their medical history carefully reviewed by the study team to ensure the study is safe and appropriate for them.

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.

Do you have a solid tumour that has returned or not responded to other treatments?
Are you 18 years old or older?
Does your tumour have specific markers that the treatment targets?
Are you generally well enough, with good organ function?
Are you willing to commit to regular hospital visits and long-term follow-up?

Answer every question to see your result.

What does participation involve?

If you are eligible and choose to take part, the first step involves providing a blood sample. This blood will be used to make your personalised LEU011 treatment in the lab. Before receiving LEU011, you will have a course of chemotherapy designed to prepare your body for the treatment. Afterwards, you'll receive LEU011 as a single infusion, which is given into a vein like a drip.

Throughout the study, you'll have regular hospital visits for check-ups and tests. These will include blood tests, scans (like CT or MRI), and other assessments to monitor your health, how the treatment is working, and any potential side effects. These visits will be frequent at first and then become less often over time.

Your participation in this particular trial will last for up to two years. Following the completion of this two-year period, you would be asked to participate in a separate, extended follow-up study for up to 15 years. This longer-term follow-up is important to understand the long-term effects of the treatment.

Potential risks and benefits

Taking part in an early-stage study like this means there are potential benefits, but also potential risks. The main potential benefit is that LEU011 might offer a new treatment option for your cancer when others haven't worked. It's designed to specifically target cancer cells, which could lead to an improvement in your condition. However, because LEU011 is new, not all side effects are fully known. There's a risk of new side effects, including serious ones, that might arise from the treatment or the chemotherapy given before it. These could affect various parts of your body. The study team will monitor you very closely for any issues and will provide emergency contact information should concerns arise after you leave the hospital. It's important to remember that participating in any clinical trial is entirely voluntary. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Guy's and St Thomas' NHS Foundation Trust
Verified postcode
London, United Kingdom· Recruiting
The Christie NHS Foundation Trust
Verified postcode
Manchester, United Kingdom· Recruiting

Common questions

What is a 'solid tumour'?

A solid tumour is a cancer that forms a solid mass or lump in the body, such as breast cancer, lung cancer, or colon cancer.

What does 'first-in-human' mean?

This means it's the very first time this new treatment has been given to people. It's a very early stage of testing.

What are CAR T-cells?

CAR T-cells are your own immune cells that have been specially trained in a lab to find and fight cancer cells more effectively.

Will I still get my usual cancer care if I join?

Joining this study is voluntary and won't affect your right to receive your usual medical care or to withdraw from the study at any time.

Why is there such a long follow-up?

A long follow-up, sometimes up to 15 years, helps researchers understand the long-term effects of the new treatment and ensure your safety over time.

How to find out more

Clinical Operations

clinops@leucid.com +44 207 118 4230 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.