Clinical Trial Using Humanized CART Directed Against BCMA (ARI0002h) in Patients With Relapsed/Refractory Multiple Myeloma to Proteasome Inhibitors, Immunomodulators and Anti-CD38 Antibody
This clinical trial is testing a new type of treatment called ARI0002h for adults with multiple myeloma, a cancer that affects plasma cells in the blood. This treatment is a special cell therapy (CAR T-cell therapy) designed to target specific cancer cells. It's being studied in patients whose multiple myeloma has returned after previous treatments or hasn't responded to standard medications, including proteasome inhibitors, immunomodulators, and an anti-CD38 antibody. The main goal is to find out how safe the treatment is and how well it works. This is a Phase II study, meaning researchers are looking at its effectiveness and safety in a larger group of people.
At a glance
What is this study about?
This study is exploring a new way to treat multiple myeloma, a type of cancer that starts in your bone marrow. When you have multiple myeloma, certain cells called plasma cells don't work properly and grow too much, which can cause problems in your body. We're looking at a treatment called ARI0002h. This isn't a typical medicine; it's a special kind of cell therapy, sometimes called CAR T-cell therapy. It involves taking some of your own immune cells, changing them in a lab so they can recognise and fight your cancer cells better, and then putting them back into your body.
This trial is specifically for people whose multiple myeloma has been particularly stubborn. This means either your cancer has come back after you've had other treatments, or those treatments haven't worked as well as hoped. These previous treatments might include certain types of drugs like proteasome inhibitors, immunomodulators, and a specific antibody therapy (we call them anti-CD38 antibodies).
The main purpose of this study is to see if this new cell therapy, ARI0002h, is safe for patients and how well it helps control their multiple myeloma. Researchers will carefully monitor how your body reacts to the treatment and look for any improvements in your condition. This information will help doctors understand if this new therapy could become a helpful option for people with this type of cancer in the future.
Key takeaways
- Tests a new cell therapy (ARI0002h) for multiple myeloma.
- For adults whose cancer hasn't responded or has returned after other treatments.
- Aims to check safety and how well it works.
- Involves regular assessments and follow-up.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To join this study, you need to be an adult, aged 18 or older. Both men and women are welcome to take part.
The study is specifically for people who have been diagnosed with multiple myeloma. It's important that your multiple myeloma has either returned after you've had other treatments, or it hasn't responded well to the treatments you've tried before. These past treatments usually include specific types of medicines like proteasome inhibitors, immunomodulators, and a medicine called an anti-CD38 antibody.
There will also be other specific health checks and tests to make sure that the treatment is suitable and safe for you to receive. Your medical team will review all your health information to see if you meet all the requirements for this study.
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 after previous treatments?
- Has your multiple myeloma not responded to past treatments like proteasome inhibitors, immunomodulators, or anti-CD38 antibody?
- Are you able to attend regular hospital visits?
What does participation involve?
If you decide to take part in this study, you will likely have several visits to the hospital or clinic. These visits will involve various tests and assessments, such as blood tests, possibly bone marrow samples, and scans, to check your overall health and how the treatment is affecting you. You will also receive the study treatment, ARI0002h, which involves preparing your body for the cell therapy, receiving the cells, and then careful monitoring afterwards.
After the initial treatment, there will be a follow-up period where doctors will continue to monitor your health and the effects of the treatment. This helps them understand the long-term safety and effectiveness. The total length of time you'll be involved in the study, including treatment and follow-up, will be explained in detail by the study team, as it can vary. All visits and procedures will be clearly outlined to you.
Potential risks and benefits
Locations (1)
- —UnverifiedSpain
Common questions
What is multiple myeloma?
Multiple myeloma is a type of cancer that affects plasma cells, which are a type of white blood cell found in your bone marrow.
What is CAR T-cell therapy?
CAR T-cell therapy is a type of treatment that uses your own modified immune cells to find and destroy cancer cells.
Who can join this study?
Adults (18 years or older) with multiple myeloma whose cancer has come back or not responded to previous standard treatments may be eligible.
What does 'relapsed/refractory' mean?
'Relapsed' means the cancer has come back after treatment. 'Refractory' means the cancer has not responded to treatment or has progressed despite treatment.
Will I get the new treatment if I join?
This is a Phase II study, so everyone in the study will typically receive the treatment being tested, ARI0002h.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
Community discussion
Powered by our forum at community.patient.info. Please be respectful — this is not medical advice.