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CAR T cells (CD33CART) to treat acute myeloid leukemia (AML) that has come back (relapsed) or has not gotten better with treatment (refractory) in children and young adults
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Phase 1, Phase 2

6 Locations

NCT03971799

Clinical Trial Goal


To find out:
  • The highest dose of CD33CART that is safe to give
  • If CD33CART is safe and works well to treat AML that has relapsed or is refractory in children and young adults

You may be able to join this trial if you:


  • Are 1 – 35 years old
  • Have AML that has relapsed or is refractory
  • Have leukemia cells with CD33 marker (CD33+). Your doctor can tell you this
  • Have a related or unrelated donor available in case you need a blood or marrow transplant (BMT)
  • Have not had a 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 CD33CART, 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 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 standard drugs: 
  • Cyclophosphamide – Given as an intravenous (IV) infusion 1 time
  • Fludarabine – Given as IV infusions 1 time each day for 2 days

Then, the CD33CART is 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’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 CD33CART to treat AML that has relapsed or is refractory in children and young adults.

Watch a video about CAR T cell therapy

Contacts


Erin Leckrone, 763-406-5124, eleckron@nmdp.org

Hati Kobusingye, 763 406 4385, hkobusin@nmdp.org

Locations

Children's Hospital of Los AngelesRecruiting

Los Angeles, California
Kimberly Arieli, karieli@chla.usc.edu

Children's Hospital of ColoradoRecruiting

Aurora, Colorado
Maggie Dyer, Maggie.dyer@childrenscolorado.org

National Cancer Institute - NIHRecruiting

Bethesda, Maryland
: NCI Pediatric Leukemia Lymphoma BMT Team, 240-760-6970, ncipbllbmt@mail.nih.gov

Dana-Farber Cancer InstituteRecruiting

Boston, Massachusetts
Ashley Miles, AshleyK_Miles@DFCI.HARVARD.EDU

The Children's Hospital of PhiladelphiaRecruiting

Philadelphia, Pennsylvania
Raabia Khan, 267-425-7196, khanr@email.chop.edu

Seattle Children's Hospital/ Fred Hutchinson Cancer Research CenterRecruiting

Seattle, Washington
Jie Lang, Jie.Liang@seattlechildrens.org

ClinicalTrials.gov record


NCT03971799

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