Clinical Trial Goal
To find out:
- The highest dose of CD22CART that's safe to give
- If CD22CART is safe and works well to treat HCL
You may be able to join this trial if you:
- Are 18 years old or older
- Have HCL (classic or variant type)
- Have leukemia cells with CD22 marker. Your doctor can tell you this
- Have not had an allogeneic (cells from a donor) blood or marrow transplant (BMT) in the last 3 months
- Agree to have other standard tests done to see if you 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.
To make CAR T cells, T cells are collected from you 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 you to find and destroy the cancer cells.
Before the CAR T-cell infusion, you’ll get chemotherapy (chemo) with 2 standard drugs:
To make CAR T cells, T cells are collected from you 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 you to find and destroy the cancer cells.
Before the CAR T-cell infusion, you’ll get chemotherapy (chemo) with 2 standard drugs:
- Cyclophosphamide – Given as an intravenous (IV) infusion 1 time
- Fludarabine – Given as IV infusions 3 times
Then, the CAR T cells are given to you through an IV infusion. The dose of cells you’ll get depends on when you start the trial and how safe it has been.
You'll have biopsies to see how well the treatment is working. The clinical trial doctors will check your health for up to 15 years.
The Food and Drug Administration (FDA) has not yet approved CD22CART.
Watch a video about CAR T-Cell Therapy
Contacts
Olena S Sierra Ortiz, (240) 858-3185, olena.sierraortiz@nih.gov
Robert J Kreitman, M.D., (301) 648-7375, kreitmar@mail.nih.gov
Locations
National Institutes of Health Clinical CenterRECRUITING
Bethesda, Maryland
For more information at the NIH Clinical Center contact National Cancer Institute Referral Office, 888-624-1937
Sponsors
lead: National Cancer Institute (NCI)
