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AuthorisedHuman Pharmacology (Phase I)- First administration to humansInterventional

A First-in-Human Study of KK2223 in Participants with T-cell Non-Hodgkin Lymphoma

This is an early-stage UK study exploring a new potential treatment, KK2223, for people diagnosed with a type of cancer called T-cell non-Hodgkin lymphoma. This includes specific types like Cutaneous T-cell lymphoma (CTCL) and Peripheral T-cell lymphoma (PTCL). The main purpose of this study is to carefully check if the new medicine is safe for people and to understand how it behaves in the body, such as how much to give and how often. This is the first time KK2223 is being given to human volunteers. Doctors will be closely monitoring participants to learn as much as possible about this new treatment.

At a glance

Status
Authorised
Phase
Human Pharmacology (Phase I)- First administration to humans
Sponsor
Kyowa Kirin Inc.
Enrolment target
34
Start
01 Apr 2026

What is this study about?

Imagine you have a type of blood cancer called T-cell non-Hodgkin lymphoma. This kind of cancer affects a part of your immune system called T-cells. Doctors are always looking for new and better ways to treat these conditions. This study is about testing a brand-new medicine, which we'll call KK2223, designed to potentially help people with this type of cancer.

This is a very early study, often called a 'Phase I' study. Think of it like taking a brand-new car for its first test drive. Doctors want to see how it performs, if it's safe to use, and what the best way to use it might be. In this case, they'll be carefully checking the new medicine's safety in people for the very first time. They also want to understand how your body handles the medicine – how much you might need, and how long it stays in your system. This helps them work out the best way to use it in future studies.

By taking part, you would be helping doctors learn important information about KK2223. This information could be very valuable for developing new treatments for T-cell non-Hodgkin lymphoma in the future, not just for you but for many other patients too.

Key takeaways

  • This is an early study of a new medicine for T-cell non-Hodgkin lymphoma.
  • It's the first time this medicine, KK2223, is being tested in humans.
  • The main goal is to check the medicine's safety and how it works in the body.
  • Participants must be aged 18 or over and have a diagnosed type of T-cell lymphoma.
  • There will be close medical monitoring throughout your participation.

Who may be eligible?

To join this study, you must be at least 18 years old. Both men and women are welcome to take part. The study is specifically for people who have been diagnosed with T-cell non-Hodgkin lymphoma, including types like Cutaneous T-cell lymphoma (CTCL) or Peripheral T-cell lymphoma (PTCL).

Because this is an early study, there will be other important health conditions or previous treatments that the doctors will need to check. These checks are put in place to help make sure the study is safe for everyone involved and that the results they get are clear. For example, they'll need to know about your overall health, any other medications you're taking, and how well your kidneys or liver are working.

If you're interested, the study doctor will go through a detailed list to see if this study is suitable for you. It's important to be open and honest about your health history so they can make the best decision for your safety.

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.

  1. Are you 18 years old or older?
  2. Have you been diagnosed with T-cell non-Hodgkin lymphoma (including CTCL or PTCL)?
  3. Are you able to attend regular hospital visits for check-ups and tests?
  4. Have you discussed this study with your main doctor or specialist?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the new medicine, KK2223. As this is the first time the medicine is being tested in humans, there will be frequent hospital visits, especially at the start, so the doctors can monitor you very closely. These visits will involve various checks, such as blood tests, physical examinations, and scans, to see how your body is reacting to the medicine and if there are any side effects. You might also be asked to provide other samples, like urine. The study team will explain exactly what each visit will involve and how long it will take. The total length of your participation will depend on how you respond to the treatment and the study plan, which the doctors will discuss with you in detail.

Potential risks and benefits

Participating in an early-stage study like this means you might be among the first to receive a new treatment that could potentially help your condition, though this is not guaranteed. However, because the medicine is new, not all its effects or side effects are known. There's a chance you might experience side effects that could be mild or more serious. The research team will monitor you very carefully for any changes and will be there to answer your questions and provide support. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

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

Common questions

What is T-cell non-Hodgkin lymphoma?

It's a type of cancer that starts in certain white blood cells called T-cells, which are part of your immune system. These cells help your body fight infections.

What does 'first-in-human' mean?

It means this is the very first time this specific new medicine is being given to people. Previous tests would have been done in laboratories or on animals.

Will I get the new medicine or a placebo (dummy drug)?

As this is a Phase I study, all eligible participants in this study would typically receive the active new medicine, KK2223, rather than a placebo.

What kinds of tests will I have?

You'll have regular medical checks, blood tests, and possibly scans or other procedures to monitor your health and how the medicine is affecting you.

Who can I talk to if I have more questions?

You should speak with your main doctor or the study team at the hospital for any questions or concerns you have.

How to find out more

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

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