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CAR T cells (BEAM-201) to treat T-cell acute lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma that has come back (relapsed) or not gotten better with treatment (refractory) in children and young adults

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Phase 1

1 Location

NCT06934382

Clinical Trial Goal


To find out:
  • The highest dose of BEAM-201 that's safe to give
  • If BEAM-201 is safe and works well to treat T-ALL or T-cell lymphoblastic lymphoma that has relapsed or is refractory in children and young adults

You may be able to join this trial if you:


  • Are 0 - 29 years old
  • Have T-ALL or T-cell lymphoblastic lymphoma that has relapsed or is refractory
  • Have cancer cells with with mutation CD7 (CD7+). Your doctor can tell you this
  • Have a donor that is willing and able to donate for you
  • Have not been treated with a drug that targets CD7
  • Have not had a blood or marrow transplant (BMT) in the last 3 months
  • Do not have acute graft-versus-host-disease (GVHD) grade 2 or more. Your doctor can tell you this
  • 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.
BEAM-201 is a type of allogeneic (cells from a donor) CAR T-cell therapy that targets CD7 on certain cells. 

To make CAR T cells, T cells are collected from a donor 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 standard drugs.

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 5 years. 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 BEAM-201. 

Watch a video about CAR T-Cell Therapy

Contacts


Cell Therapy Intake Team, 445-942-5891, CARTNurseNavigator@chop.edu

Melissa S Varghese, M.S., 845-553-5358, varghesem@chop.edu

Locations


Children's Hospital of PhiladelphiaRECRUITING

Philadelphia, Pennsylvania
Melissa S Varghese, BA, 845-553-5358, Varghesem@chop.edu

ClinicalTrials.gov record


NCT06934382. First posted on 4/18/25

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