A Phase 2 study of durcabtagene autoleucel, B-cell maturation Antigen (BCMA)-directed CAR-T Cells in adult participants with relapsed and refractory multiple myeloma
This research study is looking at a new type of treatment called durcabtagene autoleucel. It's a special cell therapy for adults who have multiple myeloma, a type of blood cancer, that has come back after previous treatments or isn't getting better with current medicines. The main goal of the study is to find out how effective this new cell therapy is at shrinking the cancer. Researchers will also look at how long the treatment works, how it affects patients' quality of life, and any side effects. This is a Phase 2 study, meaning it’s focused on checking if the treatment works and is safe in a larger group of people.
At a glance
What is this study about?
This study is focused on a new treatment called durcabtagene autoleucel, sometimes shortened to 'CAR-T cells,' for adults living with multiple myeloma. Multiple myeloma is a cancer that affects plasma cells, a type of white blood cell found in the bone marrow. When we say "relapsed and refractory," it means the cancer has returned after initial treatments, or it hasn't responded to the usual medicines.
The main aim of this study is to see how well this new CAR-T cell therapy works. CAR-T cell therapy is a cutting-edge treatment where a patient's own immune cells are collected, specially modified in a lab to better recognise and fight cancer cells, and then given back to the patient. Researchers will be carefully checking to see if the treatment helps to shrink the cancer or even make it disappear.
Beyond simply checking if the treatment works, the study will also look at other important things. This includes how long the benefits of the treatment last, whether it improves how patients feel day-to-day (their quality of life), and any side effects that might occur. The study also investigates how the treatment works in the body over time. This information helps doctors understand if this new therapy could be a good option for future patients.
Key takeaways
- This study is testing a new cell therapy (CAR-T) for multiple myeloma.
- It's for adults whose cancer has returned or isn't responding to treatment.
- The main goal is to see if the treatment shrinks the cancer.
- Researchers will also track side effects and quality of life.
- You'll have regular check-ups if you join the study.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To join this study, you must be an adult aged 18 or older. Both men and women can take part.
You would be considered for this study if you have multiple myeloma that has either come back after you've had previous treatments, or if it isn't responding to the treatments you're currently receiving. This is sometimes called "relapsed and refractory" multiple myeloma.
Before you can join, the study team will need to do some tests to make sure that this particular treatment and study are safe and suitable for your specific health situation.
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 multiple myeloma?
- Has your multiple myeloma come back or not responded to past treatments?
- Are you willing to undergo specific tests and procedures for the study?
What does participation involve?
If you decide to take part in this study, you will first undergo screening tests to confirm you are eligible. The treatment involves several stages. You may receive some medications – cyclophosphamide, fludarabine, or bendamustine – to prepare your body for the cell therapy. Then, your own immune cells will be collected. These cells will be sent away to be specially prepared as durcabtagene autoleucel.
Once your modified cells are ready, they will be given back to you. During and after this, you will be closely monitored by the study team, and you might receive other medications like tocilizumab or PHE885 if needed. You will have regular visits to the clinic for check-ups, blood tests, scans, and to discuss how you are feeling. These visits are important to track how well the treatment is working and to monitor for any side effects. The total duration of your participation, including follow-up, will be explained in detail by the study team.
Potential risks and benefits
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Common questions
What is multiple myeloma?
Multiple myeloma is a type of cancer that starts in plasma cells, which are found in your bone marrow.
What does 'relapsed and refractory' mean?
It means your cancer has either come back after treatment or isn't responding to current treatments.
What are CAR-T cells?
CAR-T cells are a specially modified type of your own immune cells, designed to find and attack cancer cells.
What will I receive in the study?
You'll receive the new cell therapy, durcabtagene autoleucel, and potentially other medications to prepare you or manage side effects.
Can I leave the study at any time?
Yes, you can choose to leave the study at any point without it affecting your usual medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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