AuthorisedHuman Pharmacology (Phase I)- First administration to humansInterventional

A first-in-human, open-label, clinical study to assess the safety, tolerability, and activity of OT-C001 (amplified/activated allogenic natural killer cells) in patients with relapsed/refractory diffuse large B-cell lymphoma

This research is testing a new treatment called OT-C001, which uses special immune cells, for adults aged 18 and over who have a specific type of blood cancer. This cancer, called diffuse large B-cell lymphoma, has either returned after initial treatments or hasn't responded to them. This is one of the very first times this treatment will be given to people, so the main aim is to check if it's safe and well-tolerated. Researchers will also be looking to see if it shows any signs of helping to fight the cancer. This is an 'open-label' study, meaning both patients and doctors will know they are receiving the new treatment.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Emercell SAS

Enrolment target

Start

04 Feb 2025

Relapsed/refractory (R/R) diffuse large B-cell lymphoma

What is this study about?

This study is about a new and experimental treatment, called OT-C001, for a type of cancer that affects white blood cells called diffuse large B-cell lymphoma. This cancer can be serious, and sometimes, even after initial treatments, it can come back (relapse) or not get better (become refractory). When this happens, doctors are always looking for new ways to help patients. This new treatment uses special immune cells, which are a part of your body's natural defence system, to try and fight the cancer.

Because this is a very early study, called a Phase 1 study, it's the first time this specific treatment will be given to people. The main purpose is to make sure it's safe for patients and to understand how their bodies react to it. Doctors will also be carefully watching to see if there are any signs that the treatment is working against the cancer cells. It's an 'open-label' study, which means everyone involved – the patients, their families, and the medical team – will know that the patient is receiving OT-C001.

The information gathered from studies like this one is really important. It helps scientists and doctors learn more about promising new treatments. If this treatment is found to be safe and shows positive signs, it could potentially be developed further in the future to help people with this type of lymphoma.

Key takeaways

Tests a new immune cell treatment (OT-C001) for a type of lymphoma.
For adults (18+) whose cancer has returned or didn't respond to treatment.
First time the treatment is given to people; primary goal is safety.
Also looking for signs that it might help control the cancer.
Patients need to attend regular clinic visits for monitoring.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you would need to be an adult, 18 years old or older. The study is open to both men and women.

The most important health condition for this study is to have a specific type of blood cancer called diffuse large B-cell lymphoma. This means your cancer has either come back after you've already had treatment, or it hasn't responded well to the treatments you've received so far.

There will be other health checks and conditions that the study doctors will need to review to make sure this treatment is safe and suitable for you. These will be discussed in detail with you by the research team.

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.

Are you 18 years old or older?
Do you have a diagnosis of diffuse large B-cell lymphoma?
Has your lymphoma come back after treatment, or did it not respond to previous treatments?
Are you able to attend regular hospital appointments for tests and treatment?
Are you happy to understand that this is a new, untested treatment in humans?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll have regular visits to the hospital or clinic. During these visits, the doctors and nurses will monitor your health very closely. This will involve physical examinations, blood tests, and other specific tests related to your cancer and the new treatment.

You will receive the OT-C001 treatment according to a schedule decided by the study doctors. After receiving the treatment, you will continue to have follow-up appointments for a period of time. These appointments are important so the research team can keep track of how you are doing, look for any side effects, and see how the treatment is affecting your cancer. The total length of your participation, including treatment and follow-up, will be explained by the study team.

Potential risks and benefits

Like any new medical treatment, there are potential risks involved. Because this is a very early study, not all side effects are known, and some could be serious. The doctors and nurses will explain all the known and potential risks to you before you decide to join. On the potential benefit side, while the main goal is to check for safety, there is a chance the treatment might help your cancer. However, there's no guarantee it will work for everyone, and it might not have any direct benefit for you personally. Remember, you can choose to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
France

Common questions

What is diffuse large B-cell lymphoma?

It's a fast-growing cancer that affects a type of white blood cell called B-lymphocytes. These cells are part of your immune system.

What does 'relapsed/refractory' mean?

It means the cancer has either returned after treatment or it didn't respond to previous treatments.

What is OT-C001?

It's a new experimental treatment using special immune cells from a donor to try and fight cancer.

What does 'first-in-human' mean?

This means it's the very first time this specific treatment is being given to people, so we are learning about its safety and effects for the first time.

Can I still receive my regular care if I join?

Yes, joining the study will not prevent you from receiving standard medical care for your condition.