BOB1-TCR therapy for treatment of relapsed or refractory B-cell malignancies - A Phase 1/2 clinical trial
This research study is investigating a new treatment called BOB1-TCR therapy for people with specific types of blood cancer that have come back or haven't responded to other treatments. These cancers include certain kinds of B-cell leukaemia, multiple myeloma, and non-Hodgkin B-cell lymphoma. The study has two main parts. The first part (Phase 1) is focused on safety: finding the right dose of the BOB1-TCR treatment that patients can tolerate well, and making sure it can be made reliably. The second part (Phase 2) will then study how effective this treatment is in fighting the cancer and will continue to monitor for any side effects over a longer period. This is one of the very first times this specific treatment will be given to people, aiming to see if it could be a helpful new option for patients.
At a glance
What is this study about?
This study is about a new and promising treatment called BOB1-TCR therapy for certain types of blood cancer. These include specific forms of B-cell leukaemia (a cancer of white blood cells), multiple myeloma (a cancer starting in the bone marrow), and non-Hodgkin B-cell lymphoma (another type of cancer affecting white blood cells).
If you have one of these conditions and your cancer has either returned after previous treatments or hasn't responded to them, this study might be relevant. The B-cell cancers are a group of conditions where certain white blood cells (B cells) grow abnormally. The BOB1-TCR therapy is designed to target and fight these specific cancer cells.
The study is split into two main sections: Phase 1 and Phase 2. Phase 1 is all about safety – it's the very first time this treatment drug, called LUMC-BOB1-B7-TCR.1, will be given to people. The main goals here are to find the right, safe dose to use and to check for any important side effects. Once a safe dose is found, Phase 2 will begin. In this phase, researchers will look more closely at how well the treatment works in reducing the cancer and will continue to monitor for any side effects over a period of up to two years. This is an important step in seeing if this new treatment could help people with these conditions.
Key takeaways
- Investigating a new treatment (BOB1-TCR therapy) for B-cell blood cancers.
- Aimed at cancers that haven't responded well to other treatments or have come back.
- Study has two parts: first to find a safe dose, then to see how well it works.
- Open to adults aged 18 and over.
- Participants will be closely monitored for safety and effectiveness for up to two years.
Who may be eligible?
To join this study, people generally need to be aged 18 or older – there's no upper age limit. The study is open to both men and women.
More specific details about your health, your type of cancer, and your previous treatments would be checked by the study doctors to see if you meet all the criteria for taking part. These checks are important to make sure the study is safe for you and that the results will be clear.
It's important to remember that not everyone with these conditions will be able to join. The study team will review your medical history carefully to decide if this particular treatment is suitable for your situation.
- Are you 18 years old or older?
- Do you have a B-cell blood cancer like specific types of leukaemia, multiple myeloma, or non-Hodgkin lymphoma?
- Has your cancer returned or not responded to previous treatments?
- Are you able to attend regular hospital appointments for tests and check-ups?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, you would first go through some screening tests to make sure the study is right for you. If you qualify, you would receive the study treatment called LUMC-BOB1-B7-TCR.1. This treatment involves a special process where your own immune cells are collected, modified in a lab, and then given back to you.
During and after receiving the treatment, you would have regular hospital visits for check-ups. These visits will involve blood tests, physical examinations, and other tests to monitor how you're responding to the treatment and to check for any side effects. These follow-up appointments will continue for up to two years after your treatment, though the frequency of visits might change over time. The study staff will explain the full schedule of appointments and what each involves.
Potential risks and benefits
Locations (1)
- —Netherlands
Common questions
What kind of cancers is this study for?
This study is for specific types of B-cell cancers, including certain forms of B-cell leukaemia, multiple myeloma, and non-Hodgkin B-cell lymphoma that have returned or not responded to other treatments.
What does 'Phase 1/2' mean?
Phase 1 means this is one of the first times this treatment is being given to people, mainly to check its safety and find the right dose. Phase 2 then looks at how well the treatment works and continues to monitor for side effects.
What is BOB1-TCR therapy?
It's a new type of treatment that uses specially modified cells to target and fight certain cancer cells in your body.
How long will I be monitored if I join?
You would be monitored closely for any side effects and how the treatment is working for up to two years after receiving the treatment.
Can anyone with these cancers join the study?
No, there are specific rules about who can join. The study team will check your medical details carefully to see if it's suitable and safe for you.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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