A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of RO7443904 in Combination with Glofitamab in Participants with Relapsed/Refractory B-Cell Non-Hodgkin’s Lymphoma
This study is investigating a new treatment for people in the UK living with a specific type of blood cancer called B-Cell Non-Hodgkin’s Lymphoma. This is for patients whose cancer has either returned after initial treatment (relapsed) or hasn't responded well to previous therapies (refractory). The new treatment involves a medicine called RO7443904, given in combination with an existing medicine called glofitamab. The main goals of this early-stage study are to understand if this new combination is safe, how well people tolerate it, how the body handles the medicines, and if it could be effective against the cancer. It's a way for doctors to learn more about promising new treatments before they can be widely used.
At a glance
What is this study about?
This clinical trial is designed to investigate a new treatment approach for B-Cell Non-Hodgkin’s Lymphoma, a type of cancer that starts in white blood cells called lymphocytes. Specifically, it's for people whose lymphoma has either come back after treatment (this is called 'relapsed') or hasn't improved with standard treatments (this is called 'refractory'). It's important to find new options for these patients.
The study involves a newer medicine called RO7443904, which is being tested alongside an existing medicine called glofitamab. The researchers want to find out several things. Firstly, they need to know if this combination treatment is safe and if people can tolerate any side effects it might cause. Secondly, they'll be looking at how the body processes these medicines, which helps them understand the right doses. Finally, they'll be watching to see if the treatment has a positive effect on the cancer.
This is an early-stage study, meaning it's one of the first times this new combination is being tested in people. Early studies like this are crucial for developing new medicines. They help doctors understand if a treatment has the potential to be a future option for patients, paving the way for larger studies if the results are promising.
Key takeaways
- This study is for adults with a type of blood cancer called B-Cell Non-Hodgkin’s Lymphoma that has come back or not responded to treatment.
- It's testing a new medicine (RO7443904) combined with another medicine (glofitamab).
- The main goals are to check if the treatment is safe, how it affects the body, and if it helps fight the cancer.
- This is an early-stage study, which is an important step in finding new treatments.
- You can ask your doctor for more information if you think this study might be for you.
Who may be eligible?
To take part in this study, you need to be an adult aged 18 or older. There is no upper age limit, so older adults can also be considered.
This study is specifically for both men and women who have been diagnosed with B-Cell Non-Hodgkin’s Lymphoma. Your lymphoma must have either returned after previous treatments or not responded to those treatments.
There will be other detailed criteria, like specific medical history and test results, that doctors will need to check to make sure the study is a safe and suitable option for you. Your blood tests, general health, and other conditions will all be carefully reviewed.
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?
- Have you been diagnosed with B-Cell Non-Hodgkin’s Lymphoma?
- Has your lymphoma come back after treatment, or not responded to previous treatments?
- Are you able to attend regular hospital visits and appointments?
- Do you feel you are generally well enough to participate in a study?
What does participation involve?
If you decide to take part in this study, you would receive the new treatment combination (RO7443904 and glofitamab). You would have regular visits to the hospital or clinic for check-ups, receiving your medication, and having assessments. These assessments would include things like blood tests, physical exams, and specialist scans to monitor your health and how the treatment is affecting your lymphoma.
The research team would closely monitor you throughout the study for any side effects or changes in your condition. After the main treatment period, there would likely be a follow-up period where you continue to have check-ups, probably less frequently, to see how you are doing in the long term. The total duration of your involvement, including treatment and follow-up, would be fully explained by the study team before you decide to join.
Potential risks and benefits
Locations (3)
- —UnverifiedDenmark
- —UnverifiedFrance
- —UnverifiedItaly
Common questions
What is B-Cell Non-Hodgkin’s Lymphoma?
It's a type of cancer that starts in white blood cells called B-lymphocytes, which are part of your immune system.
What does 'relapsed/refractory' mean?
Relapsed means your cancer has come back after treatment. Refractory means your cancer didn't respond to previous treatments.
Is this a new treatment?
Yes, RO7443904 is a new medicine being tested, used with an existing one called glofitamab, for this specific condition.
Who can join this study?
Adults aged 18 and over, both men and women, with relapsed or refractory B-Cell Non-Hodgkin’s Lymphoma who meet other specific health criteria.
What will happen during the study?
You'll receive the treatment at a clinic, have regular check-ups, blood tests, and scans to monitor your health and the cancer.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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