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AuthorisedHuman Pharmacology (Phase I)- First administration to humansInterventional

CITY

The CITY study is a research project focusing on a type of skin cancer called Cutaneous T-cell lymphoma (CTCL). Researchers are testing a potential new treatment to understand how it works and whether it’s safe for people. This is an early-stage study, meaning it's the very first time this treatment will be given to human volunteers. Doctors carefully watch participants to learn about the treatment's effects and how the body handles it. If you're an adult aged 18 or older who has been diagnosed with CTCL, you might be able to take part. The goal is to find better ways to help people with CTCL in the future.

At a glance

Status
Authorised
Phase
Human Pharmacology (Phase I)- First administration to humans
Sponsor
Assistance Publique Hopitaux De Paris
Enrolment target
35
Start
26 Sep 2025

What is this study about?

The CITY study is a medical research project designed to explore new ways of treating a condition called Cutaneous T-cell lymphoma (CTCL). CTCL is a rare type of cancer that starts in white blood cells called T-cells and mainly affects the skin, causing rashes, patches, or lumps. Finding effective treatments for CTCL is very important for improving the lives of those affected.

This particular study is exciting because it's a 'Phase 1' study. This means it's the very first time that the new treatment being investigated will be given to people. The main goals at this early stage are to see if the treatment is safe, to understand how it behaves in the body, and to figure out what dose might be most effective in future studies. It's a crucial step in developing new medicines.

By taking part, you would be helping doctors and scientists learn more about CTCL and potentially discover new treatments that could benefit many people in the future. Even at this early stage, every participant plays a vital role in advancing medical knowledge.

Key takeaways

  • The CITY study is researching a new treatment for Cutaneous T-cell lymphoma (CTCL).
  • It's an early-stage (Phase 1) study, focusing on the safety and effects of a treatment in humans for the first time.
  • Adults aged 18 and over with CTCL can be considered for participation.
  • Participation involves regular visits for health checks and to receive the study treatment.
  • You'll be closely monitored throughout the study for your safety and to understand the treatment.
  • You have the right to leave the study at any point.

Who may be eligible?

The CITY study is looking for volunteers who are at least 18 years old. There is no upper age limit, so adults of any age can be considered. Both men and women are welcome to take part in this study.

To be considered for this study, you must have a diagnosis of Cutaneous T-cell lymphoma (CTCL). The research team will need to review your medical history to make sure taking part is right for you, and that you meet certain health requirements. This is to ensure your safety and that the study results are clear.

There may be other specific health checks or criteria that doctors need to consider to make sure the study is a good fit for you. These will be discussed in detail by the study team if you are interested.

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 Cutaneous T-cell lymphoma (CTCL)?
  3. Are you able to attend regular hospital visits for check-ups and treatment?
  4. Are you willing to discuss your full medical history with the study team?
  5. Are you comfortable with receiving an experimental treatment?
Answer every question to see your result.

What does participation involve?

If you decide to take part in the CITY study, you would first have a screening visit to see if you are a good fit. This involves a review of your medical history, a physical exam, and some tests.

If eligible, you would then receive the experimental treatment. Because this is a very early-stage study (Phase 1), you would likely have a number of hospital visits. This is so the doctors and nurses can closely monitor your health, check for any changes, and see how your body is reacting to the treatment. These visits will include regular check-ups, blood tests, and possibly other evaluations to understand the treatment's effects.

The study team will explain everything in detail, including how long the treatment period lasts, what tests are involved, and how often you'd need to come in. There will also be follow-up appointments after you finish the treatment to monitor your health. The total time you'd be involved in the study would be clearly explained before you agree to participate.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. A potential benefit of taking part in the CITY study is gaining access to a new treatment that isn't yet widely available, which might help your condition. However, there's no guarantee the treatment will work for you, as its main purpose in this early stage is to test safety and how it works. Potential risks could include side effects from the treatment, which will be fully explained by the study team. They will closely monitor you for any side effects. You have the right to withdraw from 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
    France

Common questions

What is Cutaneous T-cell lymphoma (CTCL)?

CTCL is a rare type of cancer that primarily affects the skin, causing rashes, patches, or lumps. It starts in a type of white blood cell called a T-cell.

What does 'Phase 1' study mean?

Phase 1 means this is the very first time the new treatment is being given to people. Doctors are mainly checking if it's safe, how the body handles it, and what dose might be best.

Will I definitely get better if I join this study?

No, there's no guarantee. The main goal of this early study is to learn about the new treatment's safety and effects, not primarily to cure the condition. Some people might find it helps, but others might not.

What kind of commitment is involved?

You would have regular hospital visits for check-ups, physical exams, and tests (like blood tests). The study team will tell you the exact schedule and total duration if you are eligible.

Can I leave the study if I change my mind?

Yes, absolutely. You can withdraw from the study at any time, for any reason, without it affecting your medical care.

How to find out more

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

Discussion

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