Clinical Trial Goal
To find out:
- The highest dose of HG-CT-1 that's safe to give
- If HG-CT-1 is safe and works well to treat AML that has relapsed or is refractory in children and adults
You may be able to join this trial if you:
- Are 12 years old or older
- Have AML that has relapsed or is refractory
- Have cancer cells with mutation/marker FLT3 (FLT3+). Your doctor can tell you this
- Have an identified donor who is willing and able to donate for blood or marrow transplant (BMT)
Have not had allogeneic (cells from a donor) BMT in the last 3 months - Do not have graft-versus-host-disease (GVHD)
- 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.
Cyclophosphamide and fludarabine are chemotherapy (chemo) drugs that block the growth of cancer cells.
HG-CT-1 is a type of CAR T-cell therapy that targets FLT3 on certain 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:
Cyclophosphamide and fludarabine are chemotherapy (chemo) drugs that block the growth of cancer cells.
HG-CT-1 is a type of CAR T-cell therapy that targets FLT3 on certain 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:
- Cyclophosphamide – Given as intravenous (IV) infusions. The dose you'll get depends on when you start the trial and how safe it has been
- Fludarabine – Given as IV infusions. The dose you'll get depends on when you start the trial and how safe it has been
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.
The clinical trial doctors will watch you closely over 1 year. 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 HG-CT-1.
Watch a video about CAR T-Cell Therapy
Locations
Sponsors
collaborator: MD Anderson Cancer Center University of Texas, lead: Hemogenyx Pharmaceuticals LLC
