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RecruitingPHASE1INTERVENTIONAL

A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab or Glofitamab in Combination With CC-220 and/or CC-99282 in Participants With B-Cell Non-Hodgkin Lymphoma

This study is looking at new ways to treat a specific type of blood cancer called B-cell Non-Hodgkin Lymphoma. Researchers are combining different medications, including mosunetuzumab or glofitamab, with other drugs like Iberdomide or Golcadomide. The main goals are to find out if these new combinations are safe, how well they work to fight the cancer, and how the body processes the medicines. It's for adults whose Non-Hodgkin Lymphoma has come back or hasn't improved with other treatments. The study will happen in two main parts: an initial dose-finding stage to work out the best amount of medicine, and a later stage to evaluate the chosen doses in more people. This research could help find better treatment options for people with this type of cancer.

At a glance

Status
Recruiting
Phase
PHASE1
Sponsor
Hoffmann-La Roche
Enrolment target
121
Start
26 Oct 2022
Estimated completion
15 Sep 2029

What is this study about?

This study is designed to explore new treatment options for a type of blood cancer called B-cell Non-Hodgkin Lymphoma (NHL). When you have lymphoma, certain white blood cells called lymphocytes grow abnormally. In this study, doctors are looking at combinations of medicines, including two drugs called mosunetuzumab or glofitamab, alongside other medications like Iberdomide or Golcadomide. Mosunetuzumab and glofitamab are types of treatments called 'monoclonal antibodies' which are designed to help your immune system find and fight cancer cells.

The main aims are to understand how safe these new drug combinations are when given together, how well they work to shrink or control the cancer, and how your body takes in, breaks down, and gets rid of the medicines. By studying these things, doctors hope to find more effective ways to help people living with NHL, especially when previous treatments haven't worked as well as hoped.

This research is important because it could lead to new ways of treating B-cell Non-Hodgkin Lymphoma. If the treatments are found to be safe and effective, they could eventually become available to more patients in the future. Everyone involved in the study will be closely monitored to ensure their safety and to collect as much information as possible about the new treatments.

Key takeaways

  • This study is for adults with B-cell Non-Hodgkin Lymphoma that hasn't responded well to other treatments.
  • It's testing new combinations of anti-cancer medicines to see if they are safe and effective.
  • The study is in its early stages (Phase 1), focusing on finding the right dose and checking for side effects.
  • Participation involves regular checks and monitoring of your health and the cancer.
  • You would have access to potential new treatments not yet widely available.

Who may be eligible?

To join this study, you need to be at least 18 years old. You must have been diagnosed with a specific type of blood cancer called B-cell Non-Hodgkin Lymphoma, and your cancer needs to have come back or not responded well to at least two previous treatments. If your cancer is a specific type called Follicular Lymphoma, you might be able to join after just one previous treatment if it’s needed.

Your general health and physical ability to carry out daily activities will be assessed. Doctors will also need to see that your cancer is active and can be measured using scans like PET/CT. You'll also need to have healthy blood counts and other lab results, and provide a recent sample of your tumor tissue.

If you have a type of NHL called DLBCL and have only had one previous treatment, you might qualify if you can't have or have chosen not to have certain other standard treatments like a stem cell transplant or CAR T-cell therapy.

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 B-cell Non-Hodgkin Lymphoma that has come back or not responded to previous treatments?
  3. Are you generally well enough to participate in a clinical study?
  4. Is your cancer still active and measurable by scans?
  5. Are your blood tests and other lab results within healthy limits?
Answer every question to see your result.

What does participation involve?

This information isn't fully detailed in the brief summary. However, typically, taking part in a study like this would involve regular visits to the clinic for check-ups, blood tests, and scans to monitor your health and how the treatment is working. You would receive the study medications, which might be given as injections under the skin (SC) or into a vein (IV). You would also likely have specific appointments for doctor consultations and to discuss any side effects. The total length of your participation would depend on the study design and your individual response to treatment, but trials often involve an initial treatment period followed by a follow-up phase. You would receive full details of the schedule if you were considering joining.

Potential risks and benefits

Participating in a clinical trial may offer potential benefits, such as access to new, experimental treatments that are not yet widely available. These treatments might help control your cancer where standard therapies haven't worked. However, there are also potential risks involved. The new medications might cause side effects, some of which could be serious or unexpected. These will be explained in detail by the study team. You have the right to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (26)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • UCSF/Hematology, Blood & Marrow Transplant, And Cellular Therapy (HBC) Program
    Verified postcode
    San Francisco, United States· Recruiting
  • University of Colorado
    Verified postcode
    Aurora, United States· Recruiting
  • Moffitt Cancer Center
    Verified postcode
    Tampa, United States· Recruiting
  • The University of Chicago
    Verified postcode
    Chicago, United States· Recruiting
  • Levine Cancer Institute
    Verified postcode
    Charlotte, United States· Recruiting
  • UT MD Anderson Cancer Center
    Verified postcode
    Houston, United States· Recruiting
  • Soroka
    Verified postcode
    Beersheba, Israel· Recruiting
  • Rambam Health Care Campus
    Verified postcode
    Haifa, Israel· Recruiting
  • Hadassah University Hospital - Ein Kerem
    Verified postcode
    Jerusalem, Israel· Recruiting
  • Center Hospital
    Verified postcode
    Ramat Gan, Israel· Recruiting
  • Sourasky Medical Center
    Verified postcode
    Tel Aviv, Israel· Recruiting
  • IRCCS Azienda Ospedaliero Universitaria di Bologna
    Verified postcode
    Bologna, Italy· Recruiting

Common questions

What is Non-Hodgkin Lymphoma?

Non-Hodgkin Lymphoma is a type of cancer that starts in white blood cells called lymphocytes, which are part of your body's immune system.

What are Mosunetuzumab and Glofitamab?

These are special medicines called 'antibodies' designed to help your body's immune system fight off the cancer cells more effectively.

What does 'Phase 1' mean for a study?

A Phase 1 study is usually the first time a new treatment or combination of treatments is tested in people. The main goals are to check if it's safe and to find the right dosage.

What are the main goals of this study?

The main goals are to see how safe the new combinations of drugs are, how well they work against the cancer, and how your body handles them.

Will I definitely get the new treatment if I join?

In a study, you would receive the study treatment, but the specific combination might vary depending on which group you are assigned to as the study progresses through its different phases.

How to find out more

Reference Study ID Number: CO43805 https://forpatients.roche.com/

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 "A Study Evaluating the Safety, Pharmacokinetics, and Efficac…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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