Clinical Trial Goal
To find out:
- The highest dose of CAR T cells that's safe to give
- If CART123 is safe and works well to treat AML that has relapsed or is refractory
You may be able to join this trial if you:
- Are 18 years old or older
- Have AML that has relapsed or is refractory
- Have a donor that is either:
- A family member that is your half match and can be your donor
- A fully matched unrelated donor
- Do not have cancer cells with mutation JAK2 V617F. Your doctor can tell you this
- Have not had allogeneic (cells from a donor) blood or marrow transplant (BMT) in the last 3 months
- Have not been treated with CART123
- Do not have active 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.
CART123 is a type of CAR T-cell therapy that targets CD123 on certain cells.
Ruxolitinib is a small molecule inhibitor that blocks JAK1 and JAK2 in certain cells. This means the drug tries to stop certain T-cell signals that can lead to tissue damage.
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:
CART123 is a type of CAR T-cell therapy that targets CD123 on certain cells.
Ruxolitinib is a small molecule inhibitor that blocks JAK1 and JAK2 in certain cells. This means the drug tries to stop certain T-cell signals that can lead to tissue damage.
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:
- Ruxolitinib - A pill that you take by mouth 2 times each day for 6 days
Next, 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.
Then, you'll get:
- Ruxolitinib - A pill that you take by mouth 2 times each day for 2 weeks
The clinical trial doctors will watch you closely over 3 months 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 CART123.
Watch a video about CAR T-Cell Therapy
Contacts
Abramson Cancer Center Clinical Trials Service, 215-349-8245, PMCancerResearch@pennmedicine.upenn.edu
Locations
University of PennsylvaniaRECRUITING
Philadelphia, Pennsylvania
215-349-8245, PMCancerResearch@pennmedicine.upenn.edu
Sponsors
collaborator: Novartis, lead: University of Pennsylvania
