BiCAR Therapy - A Phase II Trial Evaluating Glofitamab, a Bispecific CD3xCD20 Antibody for Relapse/Refractory Lymphomas after CAR T-cells therapy
This research study, called BiCAR Therapy, is exploring a new treatment option for people living with lymphoma. Lymphoma is a type of cancer that affects the immune system. We are focusing on individuals whose lymphoma has returned or hasn't improved after other treatments, including a special type of therapy called CAR T-cell therapy. The main goal is to see if a medication called glofitamab, given alongside another drug named obinutuzumab, can help people live longer. This is a Phase II trial, meaning it's an early stage of testing, looking at how safe and effective the new treatment is. We'll also be checking how well people tolerate the treatment, their overall response to it, and its impact on their quality of life.
At a glance
What is this study about?
This study is investigating a new treatment approach for a type of cancer called lymphoma. Lymphoma affects certain cells in your immune system. Sometimes, despite receiving treatments like chemotherapy or a newer method called CAR T-cell therapy, the lymphoma can return or not respond as expected. When this happens, it's known as 'relapsed/refractory lymphoma'. Finding new and effective options for these situations is very important.
In this study, we are looking at a specific new medicine called glofitamab. Glofitamab is a type of antibody, which is a protein designed to target specific cancer cells. It’s given along with another medication called obinutuzumab. The main purpose of this study is to see if this combination of medicines can help people with relapsed/refractory lymphoma live longer. This is what doctors call 'Overall Survival'.
This is a Phase II clinical trial. This means it's an early but important stage of research where we are checking how well the treatment works and if it's safe for patients. We will also be looking at other important aspects, such as how the body reacts to the medicines (tolerability), how much the lymphoma shrinks or responds to the treatment, how long any benefits last, and if it makes a difference to a person's general well-being and quality of life.
Key takeaways
- This study is for adults with lymphoma that has returned or not responded to previous therapies, including CAR T-cell therapy.
- It's testing a new combination of drugs, glofitamab and obinutuzumab, to see if they can help people live longer.
- This is a Phase II trial, meaning it's an early but important stage of research.
- Participation involves regular hospital visits for treatment and monitoring, including tests and scans.
- There are potential benefits (new treatment access) and potential risks (side effects), which will be fully explained.
- You can withdraw from the study at any time without affecting your normal care.
Who may be eligible?
To join this study, participants generally need to be at least 18 years old. The study is open to both men and women.
Crucially, you would need to have specific types of lymphoma that have either come back after previous treatment or haven't gotten better with treatment, including if you've already had 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.
- Are you 18 years old or older?
- Have you been diagnosed with lymphoma?
- Has your lymphoma come back or not responded to past treatments?
- Have you had CAR T-cell therapy in the past for your lymphoma?
- Are you able to attend regular hospital visits and follow the study schedule?
- Are you open to trying a new, investigational treatment?
What does participation involve?
If you decide to take part, you would receive the study medications, glofitamab and obinutuzumab, as per the study plan. This might involve regular hospital visits for treatments and check-ups. You would have various assessments throughout the study, which could include blood tests, scans (like CT or PET scans) to monitor your lymphoma, and questionnaires to understand your health and how you're feeling.
The research team would follow your health closely while you are receiving treatment and continue to monitor you for a period afterwards to see how you are doing over time. The exact number of visits and the total duration in the study would be explained in detail by the study team, but clinical trials generally involve a commitment over several months to possibly a few years for treatment and follow-up.
Potential risks and benefits
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Common questions
What is lymphoma?
Lymphoma is a type of cancer that starts in infection-fighting cells of the immune system, called lymphocytes. These cells are in the lymph nodes, spleen, thymus, bone marrow, and other parts of the body.
What does 'relapsed/refractory' mean?
It means your lymphoma has either come back after a period of improvement (relapsed) or it hasn't responded to previous treatments (refractory).
What is CAR T-cell therapy?
CAR T-cell therapy is a newer treatment where a patient's own immune cells (T-cells) are taken from their blood, modified in a lab to fight cancer, and then put back into the patient.
What is glofitamab?
Glofitamab is a drug being tested; it's an antibody designed to help your immune system recognise and attack lymphoma cells more effectively.
Will I definitely get the new treatment if I join?
Yes, in this Phase II study, all participants will receive the study medications (glofitamab and obinutuzumab).
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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