Clinical Trial Goal
To find out:
- The highest dose of CAR T cells that's safe to give
- If CAR T cells are safe and work well to treat acute leukemia that has relapsed or is refractory in children, teens and young adults
You may be able to join this trial if you:
Your child:
- Is 21 years old or younger
- Has acute leukemia that has relapsed or is refractory
- Has cancer cells with mutation/marker CD19 (CD19+) or CD22 (CD22+). Your child's doctor can tell you this
- You agree to have other standard tests done to see if your child can be in the clinical trial
Trial Details
CAR stands for chimeric antigen receptors and T stands for T cells, a type of immune cell. This treatment helps your own immune system find and destroy cancer cells.
CD-19-CD22 is a type of CAR T-cell therapy that targets CD19 and CD22 on certain cells.
Cyclophosphamide and fludarabine are chemotherapy (chemo) drugs that block the growth of cancer cells.
Mesna is a drug that helps protect your bladder from the side effects of chemotherapy (chemo).
To make CAR T cells, T cells are collected from your child by apheresis. Apheresis is a process to collect cells from the bloodstream using a needle similar to when you donate blood. The T cells are genetically modified to grow special proteins called CARs. CARs help T cells find the cancer cells. The CAR T cells are grown in a lab until there are millions of them. Then, they’re given back to your child to find and destroy the cancer cells.
Before the CAR T-cell infusion, your child will get treatment with 3 standard drugs:
CD-19-CD22 is a type of CAR T-cell therapy that targets CD19 and CD22 on certain cells.
Cyclophosphamide and fludarabine are chemotherapy (chemo) drugs that block the growth of cancer cells.
Mesna is a drug that helps protect your bladder from the side effects of chemotherapy (chemo).
To make CAR T cells, T cells are collected from your child by apheresis. Apheresis is a process to collect cells from the bloodstream using a needle similar to when you donate blood. The T cells are genetically modified to grow special proteins called CARs. CARs help T cells find the cancer cells. The CAR T cells are grown in a lab until there are millions of them. Then, they’re given back to your child to find and destroy the cancer cells.
Before the CAR T-cell infusion, your child will get treatment with 3 standard drugs:
- Cyclophosphamide – Given as intravenous (IV) infusions. The dose your child will get depends on when they start the trial and how safe it has been
- Fludarabine – Given as IV infusions. The dose your child will get depends on when they start the trial and how safe it has been
- Mesna - Given as IV infusions. The dose your child will get depends on when they start the trial and how safe it has been
Then, the CAR T cells are given to your child through an IV infusion. The dose of cells your child will get depends on when they start the trial and how safe it has been.
The clinical trial doctors will watch your child closely over 1 month. Your child will have biopsies to see how well the treatment is working. The clinical trial doctors will check your child's health for up to 15 years.
The Food and Drug Administration (FDA) has not yet approved CD19-CD22 CAR T cell therapy.
Watch a video about CAR T-Cell Therapy
Locations
St. Jude Children's Research HospitalRECRUITING
Memphis, Tennessee
Rebecca Epperly, MD, 888-226-4343, referralinfo@stjude.org
Sponsors
lead: St. Jude Children's Research Hospital
