Clinical Trial Goal
To find out if CAR19PK is safe and works well to treat CD19+ 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 0 - 21 years old
- Has CD19+ leukemia that has relapsed or is refractory
- Does not have graft-versus-host-disease (GVHD)
- Has not had an allogeneic (cells from a donor) blood or marrow transplant (BMT) in the last 3 months
- 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.
CAR19PK is a type of CAR T-cell therapy that targets CD19 on certain cells.
Cyclophosphamide and fludarabine are chemotherapy 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 chemo with 2 standard drugs:
CAR19PK is a type of CAR T-cell therapy that targets CD19 on certain cells.
Cyclophosphamide and fludarabine are chemotherapy 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 chemo with 2 standard drugs:
- Cyclophosphamide – Given as intravenous (IV) infusions
- Fludarabine – Given as IV infusions
Then, the CAR T cells are given to your child through an IV infusion.
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 CAR19PK.
Watch a video about CAR T-Cell Therapy
Locations
St. Jude Children's Research HospitalRECRUITING
Memphis, Tennessee
Aimee Talleur, MD, 866-278-5833, referralinfo@stjude.org
Sponsors
lead: St. Jude Children's Research Hospital
