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
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.
- Are you 18 years old or older?
- Do you have aggressive B-cell non-Hodgkin lymphoma that has come back or not responded to past treatments?
- Have you already had at least two previous lines of treatment for your lymphoma?
- Are you able to have regular hospital visits and tests?
- Are you generally well, with your organs working adequately?
- Are you not currently involved in another clinical trial?
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
Locations (36)
- Centre Hospitalier Le MansVerified postcodeLe Mans, France· Recruiting
- CHU de Lille - Hôpital Claude HuriezVerified postcodeLille, France· Recruiting
- CHU de Limoges - CHU DupuytrenVerified postcodeLimoges, France· Recruiting
- Hospices Civils De Lyon - Hôpital Lyon SudVerified postcodeLyon, France· Recruiting
- CHU Montpellier - Hôpital Saint EloiVerified postcodeMontpellier, France· Recruiting
- APHP - Hôpital Pitié-SalpêtrièreVerified postcodeParis, France· Recruiting
- CHU de Bordeaux - Hôpital Haut-LévêqueVerified postcodePessac, France· Recruiting
- Wojewódzki Szpital Specjalistyczny w Białej PodlaskiejVerified postcodeBiała Podlaska, Poland· Recruiting
- IN-VIVO Bydgoszcz Sp. z o.o.Verified postcodeBydgoszcz, Poland· Recruiting
- Klinika Hematologii I Transplantologii UckVerified postcodeGdansk, Poland· Not yet recruiting
- Szpitale Pomorskie Sp. z o.o.Verified postcodeGdynia, Poland· Recruiting
- Narodowy Instytut Onkologii im. Marii Skłodowskiej Curie, Państwowy Instytut BadawczyVerified postcodeGliwice, 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?
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