Cancer – PLAT-08: A Phase 1 Study of SC-DARIC33 in Children and Young Adults with Relapsed or Refractory CD33+ AML
Condition or Therapy:
Relapsed/refractory acute myeloid leukemia in children and young adults
What is the goal of this study?
PLAT-08 is a phase 1 clinical trial. Phase 1 trials focus on finding out a dose that can be safely given.
This study uses a kind of CAR T cell known as a DARIC T cells. The DARIC T cells that we use on this study (called SC-DARIC33) are designed to be given with a drug called rapamycin, which turns the DARIC T cell on. Being able to turn the DARIC cells on and off may help control the side effects of the treatment and help the DARIC T cells last longer.
The goals of the PLAT-08 study are to find out:
- How safe are the SC-DARIC33 T cells?
- What are the side effects of the SC-DARIC33 T cells?
- How well does this SC-DARIC33 T cell treatment fight cancer?
- How long do the SC-DARIC33 T cells stay in your body?
- How do SC-DARIC33 T cells act inside your body?
- How much rapamycin is needed to turn the activity of DARIC T cells on?
Who can join the study?
This study might be a good fit for children and young adults who:
- Are ages 0 to 30 years old.
- Have relapsed or refractory CD33+ acute myeloid leukemia.
What will happen if my child takes part in this study?
If you choose to participate in the study, you would need to have your T cells collected. This is done by a process called apheresis. During apheresis, blood is removed and run through an apheresis machine, which collects the white blood cells and returns the rest of your blood to you through the IV or temporary apheresis catheter.
After apheresis, your white blood cells, labeled with your information above, will be sent to the Therapeutics Cell Manufacturing Facility, part of Seattle Children’s Therapeutics, where your T cells will be changed and grown to make your DARIC T cell treatment.
Before you get the DARIC T cells, you would have tests and a physical exam by one of the study providers to make sure it is safe for you to receive them. You would also need some more chemotherapy to make room for your DARIC T cells.
You would then receive your DARIC T cells as an infusion. About two days after you have received the DARIC T cells, you would start to take rapamycin, the drug that turns the DARIC T cells on. You would be expected to take rapamycin for 19 days. After receiving DARIC T cells, you would be followed closely for 6 weeks with 11 visits to the hospital during those 6 weeks.
After this initial close follow up period, you would continue to be followed up for 15 years. These visits would be frequent in the first few years and then annual. You could have these visits at Seattle Children's Hospital or at your local hospital if you wanted.
You can read more about the PLAT-08 study on clinicaltrials.gov.