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RecruitingPHASE2INTERVENTIONAL

MEN1703 (SEL24) to Treat Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma (JASPIS-01)

This study, called JASPIS-01, is for people with aggressive B-cell non-Hodgkin lymphoma that has come back or isn't responding to their current treatments. Researchers are testing a new drug, MEN1703 (also known as Dapolsertib hydrochloride). It will be given either on its own or together with another drug called glofitamab. The main goal is to check how safe these treatments are and if they can help shrink the lymphoma. There are two groups of patients: one group hasn't had a specific type of antibody treatment before, while the other group has tried many standard treatments and needs new options. The study will look at different doses and combinations of the drugs.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
Ryvu Therapeutics SA
Enrolment target
178
Start
05 Dec 2024
Estimated completion
01 Dec 2026

What is this study about?

This study is looking into new ways to treat a type of cancer called aggressive B-cell non-Hodgkin lymphoma. This is a type of blood cancer where certain white blood cells behave abnormally. Sometimes, despite treatment, this lymphoma can come back or stop responding to the medicines. When this happens, doctors call it "relapsed or refractory" lymphoma.

The study involves two experimental drugs: MEN1703 (also called Dapolsertib hydrochloride) and glofitamab. Researchers want to see if MEN1703, given by itself or with glofitamab, can be a safe and effective treatment option for people whose lymphoma has returned or isn't responding to other treatments. "Safe" means making sure the side effects aren't too severe, and "effective" means watching if the drugs can shrink the lymphoma or stop it from growing.

The study is divided into different parts and enrols two main groups of patients. One group will be people who haven't had a specific type of powerful antibody treatment before, but have tried at least two other standard treatments. The second group includes people who have already tried many standard treatments, including the antibody treatments, and are looking for new options. Depending on which group you are in, you might receive MEN1703 alone or a combination of MEN1703 and glofitamab. The study will carefully check how well these treatments work and how patients feel during the process.

Key takeaways

  • This study is for adults with aggressive B-cell non-Hodgkin lymphoma that has returned or isn't responding to standard treatments.
  • It tests new drugs, MEN1703 (alone or with glofitamab), to check safety and effectiveness.
  • There are different treatment pathways depending on your past medical history.
  • Participation involves regular hospital visits, tests, and closely monitored drug administration.
  • Potential benefits include access to new treatments; risks include unknown side effects.
  • You have the right to leave the study at any time.

Who may be eligible?

To join this study, you would need to be at least 18 years old and have been diagnosed with aggressive B-cell non-Hodgkin lymphoma that has either come back or isn't responding to past treatments. You must have already had at least two different courses of standard treatment for your lymphoma.

It's important that you are generally well enough to take part, with your body's organs working adequately. Doctors will check for things like your blood counts, kidney function, and liver function. You also need to have at least one measurable area of lymphoma that doctors can track with scans.

There are also reasons why you might not be able to join. For example, if your lymphoma is in your brain or spinal cord, or if you've recently had other anti-cancer treatments within a couple of weeks, you might not be eligible. If you've had a specific type of treatment called a PIM inhibitor before, you wouldn't be able to participate either. The researchers will also make sure you don't have allergies to the study drugs or other health problems that could make the treatment unsafe for you.

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. Do you have aggressive B-cell non-Hodgkin lymphoma that has come back or not responded to past treatments?
  3. Have you already had at least two previous lines of treatment for your lymphoma?
  4. Are you able to have regular hospital visits and tests?
  5. Are you generally well, with your organs working adequately?
  6. Are you not currently involved in another clinical trial?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned to one of two main groups, depending on your past treatments. You might receive MEN1703 alone or MEN1703 combined with glofitamab. The researchers will start with different doses to find the safest and most effective amount.

The treatment is given in cycles, with each cycle lasting 21 days. If you're in Group 1, you'll have treatment for a maximum of 12 cycles. If you're in Group 2, you'll continue treatment as long as the doctors see a benefit and the lymphoma isn't getting worse. During the study, you'll have regular hospital visits for check-ups, blood tests, and scans (like CT or PET-CT scans) to see how you're responding to the treatment and to monitor your general health. You may also need to provide a small sample of your lymph node tissue.

Potential risks and benefits

Taking part in a clinical trial means you might be among the first to receive a new treatment that could potentially help manage your lymphoma, especially if standard treatments haven't worked well. However, this is still an experimental treatment, and there's no guarantee it will be effective for you. There will likely be side effects, some of which might be serious, and the full extent of these is still being understood. Your medical team will carefully monitor you for any side effects and manage them as best they can. You are free to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (36)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Centre Hospitalier Le Mans
    Verified postcode
    Le Mans, France· Recruiting
  • CHU de Lille - Hôpital Claude Huriez
    Verified postcode
    Lille, France· Recruiting
  • CHU de Limoges - CHU Dupuytren
    Verified postcode
    Limoges, France· Recruiting
  • Hospices Civils De Lyon - Hôpital Lyon Sud
    Verified postcode
    Lyon, France· Recruiting
  • CHU Montpellier - Hôpital Saint Eloi
    Verified postcode
    Montpellier, France· Recruiting
  • APHP - Hôpital Pitié-Salpêtrière
    Verified postcode
    Paris, France· Recruiting
  • CHU de Bordeaux - Hôpital Haut-Lévêque
    Verified postcode
    Pessac, France· Recruiting
  • Wojewódzki Szpital Specjalistyczny w Białej Podlaskiej
    Verified postcode
    Biała Podlaska, Poland· Recruiting
  • IN-VIVO Bydgoszcz Sp. z o.o.
    Verified postcode
    Bydgoszcz, Poland· Recruiting
  • Klinika Hematologii I Transplantologii Uck
    Verified postcode
    Gdansk, Poland· Not yet recruiting
  • Szpitale Pomorskie Sp. z o.o.
    Verified postcode
    Gdynia, Poland· Recruiting
  • Narodowy Instytut Onkologii im. Marii Skłodowskiej Curie, Państwowy Instytut Badawczy
    Verified postcode
    Gliwice, Poland· Recruiting

Common questions

What is aggressive B-cell non-Hodgkin lymphoma?

It's a fast-growing cancer of the white blood cells called B-lymphocytes, which are part of your immune system.

What do 'relapsed' or 'refractory' mean?

Relapsed means the lymphoma has come back after treatment. Refractory means it hasn't responded to previous treatments.

What are MEN1703 and glofitamab?

These are experimental drugs being tested to treat this type of lymphoma. They work in different ways to fight cancer.

Will I know which treatment I'm getting?

Yes, for most of the study, you will know. In one optional part, some patients might be chosen randomly to receive either the combination treatment or glofitamab alone.

How long will I be in the study?

If you're in Group 1, up to 12 cycles (about 8 months). If you're in Group 2, you'll continue as long as the treatment helps and you tolerate it well.

How to find out more

Head of Clinical Operations

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

Interested in taking part?

Register your interest

Share your details and the research team for "MEN1703 (SEL24) to Treat Relapsed or Refractory Aggressive B…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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