Clinical Trial Goal
To find out:
- The highest dose of CYAD-02 that’s safe to give
- If CYAD-02 is safe and works well to treat AML or MDS that has relapsed or is refractory
You may be able to join this trial if you:
- Are 18 years old or older
- Have one of the following diseases that has relapsed or is refractory, and there are no more standard treatments available:
- AML
- MDS that doctors consider intermediate or high risk
- Agree to have other standard tests done to see if you can be in the clinical trial
Trial Details
CYAD-02 is a type of CAR T therapy. 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 CYAD-02, 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 CYAD-02 infusion, you’ll get chemotherapy (chemo) with:
To make CYAD-02, 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 CYAD-02 infusion, you’ll get chemotherapy (chemo) with:
- Cyclophosphamide – Given as intravenous (IV) infusions 1 time each day for 3 days
- Fludarabine – Given as IV infusions 1 time each day for 2 days
Then, the CYAD-02 is given to you through an IV infusion up to 4 times. The dose you’ll get depends on when you start the trial and how safe it’s been.
The clinical trial doctors will watch you closely over the first 24 hours. You’ll have biopsies to see how well 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 CYAD-02.
Watch a video about CAR T cell therapy
Locations
Mayo Clinic Cancer CenterNOT_YET_RECRUITING
Jacksonville, Florida
Mohamed Kharfan Dabaja, MD, 904-953-3376
University of Kansas Cancer CenterRECRUITING
Fairway, Kansas
Tara LIN, MD, 913-945-5052
Sponsors
lead: Celyad Oncology SA
