Measurable residual disease driven strategy for one or two infusions of nonviral, transposon-manipulated CARCIK CD19 cells. A Phase II study in pediatric and adult patients with relapsed/refractory B cell precursor ALL (BCP-ALL).
This research study is for adults with a type of blood cancer called B-cell Acute Lymphoblastic Leukaemia (B-cell ALL) if their cancer has returned or hasn't improved with other treatments. It's looking at a new cell therapy called CARCIK-CD19. This therapy uses specially changed immune cells to fight the cancer. We want to find out how many people respond to this treatment within 28 days of their first dose. We'll also be tracking how long the positive effects last, whether they receive one or two doses. The study will also carefully check for any side effects to make sure the treatment is safe, both after the first and potentially second dose, and to see if there are differences in safety depending on where the cells come from. Participants will be closely monitored to understand their overall health and well-being during the study.
At a glance
What is this study about?
This study is about a new way to treat a type of blood cancer called B-cell Acute Lymphoblastic Leukaemia (B-cell ALL). This cancer affects white blood cells and can be very serious. Sometimes, standard treatments don't work, or the cancer comes back. This study is for those adults whose B-cell ALL has returned or hasn't responded to previous treatments.
The new treatment being tested is called CARCIK-CD19. It's a type of cell therapy. In simple terms, it involves taking special immune cells, called T-cells, and changing them in a laboratory so they become very good at finding and attacking cancer cells that have a specific marker (called CD19) on their surface. These changed cells are then given back to the patient. The aim is for these 'super-powered' cells to destroy the cancer.
The main goal of this study is to see how many patients respond positively to the CARCIK-CD19 treatment within 28 days of their first dose. We also want to understand how long these positive effects last. The study will also be looking very carefully at how safe this treatment is, checking for any side effects after one or two doses, and seeing if the safety varies depending on whether the cells are from the patient themselves, a donor, or umbilical cord blood. Ultimately, this research aims to find out if CARCIK-CD19 could be a helpful new treatment option for B-cell ALL.
Key takeaways
- This study is for adults with B-cell ALL that has returned or is hard to treat.
- It uses a new cell therapy called CARCIK-CD19 to target cancer.
- The main goals are to see how many people respond and for how long.
- Safety is a major focus, with careful monitoring for side effects.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
This study is open to adults who are 18 years old and older. It doesn't matter if you are male or female, as long as you meet the other requirements.
To be considered for this study, you must have B-cell Acute Lymphoblastic Leukaemia (B-cell ALL). This means your condition would need to be in a specific phase where it has either come back after previous treatments or hasn't responded well to those treatments.
There will be other important health checks and specific medical criteria that your doctor will need to review to make sure this study is safe and appropriate for you. They will explain all of these in detail.
- Are you 18 years old or older?
- Have you been diagnosed with B-cell Acute Lymphoblastic Leukaemia (B-cell ALL)?
- Has your B-cell ALL come back after treatment, or has it not responded to previous treatments?
- Are you able to attend regular hospital appointments for treatment 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 will receive doses of the CARCIK-CD19 treatment. This will involve at least one administration, and for some, potentially a second dose, usually given through an intravenous drip, similar to how you might receive other medications. You will have regular hospital visits, especially in the initial stages, for medical assessments, blood tests, and scans to check how you are responding to the treatment and to monitor for any side effects.
These assessments typically include checking your blood counts, looking for signs of cancer in your blood and bone marrow, and reviewing your general health. After the initial treatment period, follow-up visits will continue for a longer time, becoming less frequent as time goes on. These follow-up appointments are important to see how your health is over the long term and to track the lasting effects of the treatment. The total duration of your participation, including follow-up, could be several years.
Potential risks and benefits
Locations (1)
- —Italy
Common questions
What kind of cancer is B-cell ALL?
B-cell ALL is a fast-growing cancer of white blood cells that starts in the bone marrow, the soft inside part of your bones.
What is CARCIK-CD19?
CARCIK-CD19 is a special cell therapy where immune cells are modified in a lab to specifically find and attack your cancer cells.
Is this treatment entirely new?
Yes, this is a new type of treatment being studied to see its effects, especially in patients whose cancer has come back or not responded to other treatments.
How long will I be involved in the study?
Your involvement, including treatment and follow-up, could last for several years to monitor long-term effects.
Can I stop being part of the study at any time?
Yes, you have the right to leave the study at any time, and this will not affect your future 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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