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Allogeneic (cells from a donor) CAR T cells (CD30.CAR-EBVST) to treat lymphoma that has come back (relapsed) or has not gotten better with treatment (refractory) in children and adults

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12 - 75

Phase 1

2 Locations

NCT04288726

Clinical Trial Goal


To find out:
  • The highest dose of CD30.CAR-EBVST that's safe to give
  • If CD30.CAR-EBVST is safe and works well to treat lymphoma that has relapsed or is refractory in children and adults

You may be able to join this trial if you:


  • Are 12 - 75 years old
  • Have 1 of the following types of lymphoma that has relapsed or is refractory:
    • Anaplastic T-cell lymphoma (ATCL)
    • Diffuse large B-cell lymphoma (DLBCL)
    • Extranodal NK/T-cell lymphoma 
    • Hodgkin lymphoma
    • Peripheral T-cell lymphoma (PTCL)
    • Post-transplant lymphoproliferative disease (PTLD)
  • Have lymphoma cells with CD30 marker. 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


CD30.CAR-EBVST are created from Epstein Barr virus (EBV)-specific T cells from a donor that target CD30 on certain cells. CAR stands for chimeric antigen receptors and T stands for T cells, a type of immune cell. Doctors think this treatment will help find and destroy cancer cells.

In this trial, you’ll be placed in 1 of 2 groups depending on if you've had a blood or marrow transplant (BMT) recently:
  • Group 1 – Have not had a BMT recently
  • Group 2 – Have had a BMT recently

If you're in Group 1, you’ll first get standard chemotherapy (chemo) with 2 of drugs:
  • Cyclophosphamide – Given as intravenous (IV) infusions
  • Fludarabine –  Given as IV infusions

Both groups will get CD30.CAR-EBVST given to you through an IV infusion that lasts 10 minutes. The dose of CD30.CAR-EBVST 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 the first 3 hours. You'll have biopsies and/or scans to see how well the treatment is working. The clinical trial doctors will check your health for up to 5 years.

The Food and Drug Administration (FDA) has approved cyclophosphamide and fludarabine to treat lymphoma. The FDA has not yet approved CD30.CAR-EBVST.

Contacts


Carlos Ramos, MD, 832-824-4817, caramos@bcm.edu

Vicky Torrano, (832) 824-7821, vtorrano@bcm.edu-

Locations


Houston Methodist HospitalRECRUITING

Houston, Texas
Carlos Ramos, MD, (713) 441-1450, caramos@bcm.edu

Texas Children's HospitalRECRUITING

Houston, Texas
Carlos Ramos, MD, (713) 441-1450, caramos@bcm.edu

ClinicalTrials.gov record


NCT04288726. First posted on 2/28/20

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