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Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

TELLOMAK: T-cell Lymphoma anti-KIR3DL2 therapy. An open label, multi-cohort, multi-center phase II study evaluating the efficacy and safety of IPH4102 alone or in combination with chemotherapy in patients with advanced T-cell lymphoma.

This research, called TELLOMAK, is looking into a new treatment called lacutamab for advanced forms of T-cell lymphoma. This includes specific types of skin lymphoma like Sézary Syndrome (when it has come back or isn't responding to other treatments) and Mycosis Fungoides (stages 1B to 4). The study wants to find out if lacutamab, given by itself or with chemotherapy, can shrink the cancer or stop it from getting worse. Researchers will also be checking for any side effects and how the medicine affects patients' quality of life. The main goal is to see how many people respond to the treatment, meaning their cancer either shrinks completely or partially. This is a Phase II study, which means it's testing a new treatment that has already shown some promise in earlier research.

At a glance

Status
Ongoing, recruiting
Phase
Therapeutic exploratory (Phase II)
Sponsor
Innate Pharma
Enrolment target
104
Start
30 Apr 2024

What is this study about?

This study, called TELLOMAK, is exploring a new medicine named lacutamab for people living with advanced T-cell lymphomas. These are cancers that affect a type of white blood cell called T-cells. Specifically, the study is focusing on certain types of skin T-cell lymphomas, such as Sézary Syndrome that has come back or isn't responding to current treatments, and Mycosis Fungoides at more advanced stages (Stage 1B to 4).

The main purpose of this research is to see how effective and safe lacutamab is. Researchers want to know if it can shrink the cancer or stop it from growing. They will be looking at this when lacutamab is given on its own, and also when it's given together with standard chemotherapy treatments.

Studying new medicines like lacutamab is important because it helps doctors find better ways to treat these types of cancer, potentially offering new hope for patients when other treatments haven't worked or have stopped working. The information gathered from this study will help us understand more about how this medicine works and if it could become a standard treatment in the future.

Key takeaways

  • This study is testing a new medicine called lacutamab for advanced T-cell lymphomas.
  • It focuses on certain types of skin T-cell lymphoma like Sézary Syndrome and Mycosis Fungoides.
  • Researchers want to see how well lacutamab works (is it effective?) and if it's safe.
  • The medicine may be given alone or with chemotherapy.
  • Participants will have regular check-ups, blood tests, and answer questions about their quality of life.
  • Joining a study offers potential access to new treatments but also comes with risks.

Who may be eligible?

To join this study, you must be at least 18 years old. The study is open to both men and women.

It is specifically for people who have been diagnosed with advanced T-cell lymphoma. This includes certain types of skin T-cell lymphomas, such as Sézary Syndrome where the cancer has returned or isn't getting better with other treatments, and Mycosis Fungoides that is at stage 1B, 2, 3, or 4.

There might be other health requirements or conditions that would mean you can or cannot join the study. If you think you might be eligible, it's best to talk to your doctor or the study 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.

  1. Are you 18 years old or older?
  2. Have you been diagnosed with advanced T-cell lymphoma?
  3. Do you have Sézary Syndrome that has come back or isn't responding to treatment?
  4. Do you have Mycosis Fungoides at stage 1B, 2, 3, or 4? (Note: Stage 1B is relevant here)
  5. Are you able to attend clinic visits regularly?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the study medicine, lacutamab, alone or possibly with chemotherapy, depending on which group you are in. You will have regular visits to the clinic so doctors can monitor your health, check for any side effects, and see how the treatment is affecting your cancer. These visits will involve physical exams, blood tests, and possibly other scans or tests.

Researchers will also ask you about your quality of life, using special questionnaires that ask how you are feeling and how your symptoms (like itching) are. They will also take blood samples to measure the amount of the study medicine in your body and see how your immune system reacts to it.

The total amount of time you spend in the study will vary depending on how you respond to the treatment and your individual circumstances. There will also be follow-up checks after you finish treatment.

Potential risks and benefits

Taking part in a clinical study offers potential benefits such as access to a new treatment before it's widely available and closer monitoring of your health. However, there are also potential risks, including side effects from the study medicine or other treatments, which will be carefully monitored. Not everyone will benefit from the treatment, and it may not work for your cancer. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (6)

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

Common questions

What is T-cell lymphoma?

T-cell lymphoma is a type of cancer that starts in white blood cells called T-cells, which are part of your immune system. It can affect different parts of the body, including the skin.

What does 'advanced' T-cell lymphoma mean?

Advanced means the cancer has spread or is at a later stage, or that previous treatments haven't been successful.

What is lacutamab?

Lacutamab is a new medicine being tested in this study. It aims to target specific cells linked to T-cell lymphoma.

What does a 'Phase II study' mean?

A Phase II study means researchers are looking more closely at how well a new treatment works and if it's safe, after it has already shown some promise in earlier, smaller studies.

Will I definitely get the new medicine?

Yes, in this study, all participants will receive lacutamab, either on its own or combined with chemotherapy, as there is no placebo group.

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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