Ongoing, recruitingPhase I and Phase II (Integrated)- First administration to humansInterventional

An open-label, multi-centre, phase I/IIa study evaluating the safety and clinical activity of neoantigen reactive T cells in patients with advanced non-small cell lung cancer

This research trial is testing a new way to treat advanced non-small cell lung cancer, a type of lung cancer. It's called a 'Phase I/IIa' study, which means it's one of the first times this new treatment will be given to people. The study will look at a special cell therapy called ATL001, either on its own or together with an approved cancer medicine called KEYTRUDA. Researchers want to find out how safe these treatments are and if they can help shrink tumours. They will carefully monitor for any side effects and see how the cancer responds over time. This trial is open to adults aged 18 and over who have this specific type of lung cancer.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- First administration to humans

Sponsor

Achilles Therapeutics UK Limited

Enrolment target

Start

03 Jun 2024

Non-small cell lung cancer

What is this study about?

This study is a clinical trial, which means it's a carefully planned medical research project to find out if a new treatment is safe and effective. It's for people with advanced non-small cell lung cancer that has spread or is hard to treat. The study is investigating a new treatment that uses your body's own immune system to fight cancer.

The main aim of this trial is to understand how safe the new treatment components are. The researchers will be closely watching for any side effects, both mild and serious, from each part of the treatment process. They will also look at whether the treatment can help slow down or shrink the cancer.

The treatment being tested involves a special cell therapy called ATL001. This might be given on its own or together with pembrolizumab (also known as KEYTRUDA), which is a common cancer medication. Another medicine called IL-2 is also used. The study wants to see how these treatments work together and whether they can make a difference for people with this type of lung cancer.

Key takeaways

This study explores a new cell therapy (ATL001) for advanced lung cancer.
It combines ATL001 with existing treatments like KEYTRUDA.
The main goals are to check safety and see if tumours shrink.
It's an early-stage trial (Phase I/IIa) for adults aged 18 and over.
Participation involves regular clinic visits, tests, and treatments.

Who may be eligible?

This study is for adults, aged 18 or older, who have been diagnosed with advanced non-small cell lung cancer.

Because medical trials are very specific, not everyone with this condition will be able to take part. Researchers need to make sure the treatment is suitable for your particular health situation. This means they will look at things like your general health, other medical conditions you might have, and any previous treatments you've received.

You will have a full medical check-up and doctors will review your medical history to see if this study is right for you. Both men and women can participate.

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 18 years old or older.
I have been diagnosed with advanced non-small cell lung cancer.
I am able to attend regular clinic appointments.
I am willing to undergo medical tests and procedures required by the study.

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have some screening tests to check if the study is suitable for you. This will likely involve blood tests, scans, and other medical examinations.

The treatment itself will involve several steps, including tissue procurement (taking a small sample from your body, likely a tumour biopsy) and receiving different medications. You will have regular visits to the clinic for treatments, check-ups, and to monitor your health and the cancer's response. This will include further blood tests, scans, and physical examinations.

Throughout the study, the medical team will keep a close eye on you for any side effects. You'll need to attend all scheduled appointments. The total duration of your participation, including follow-up, will be explained in detail by the study team.

Potential risks and benefits

Taking part in a clinical trial offers the chance to access new treatments that aren't yet widely available, which could potentially help your condition. However, new treatments also carry unknown risks and side effects that doctors are still working to understand. The treatments in this study involve powerful medications and cell therapies which could cause serious side effects, and there's no guarantee the treatment will work for everyone. You 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
France

Common questions

What is 'non-small cell lung cancer'?

It's the most common type of lung cancer, and 'advanced' means it may have spread to other parts of the body.

What is KEYTRUDA?

KEYTRUDA is a type of immunotherapy that helps your body's immune system fight cancer cells.

What is 'cell therapy'?

Cell therapy uses special cells, often from your own body, to treat diseases. In this case, it might involve immune cells trained to fight cancer.

Will I get the new treatment or a placebo?

This study does not use a placebo. Patients will receive the new cell therapy (ATL001), either alone or with KEYTRUDA, plus other supportive medicines.

What does 'Phase I/IIa' mean?

It means this is an early-stage study, checking the safety of the treatment first, and then looking at how well it might work.