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CAR T cells (DuoCAR20.19.22-D95) to treat B-cell acute lymphoblastic leukemia (B-ALL) or B-cell non-Hodgkin lymphoma (B-NHL) that has come back (relapsed) or not gotten better with treatment (refractory)

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18 and older

Phase 1

1 Location

NCT06879340

Clinical Trial Goal


To find out:
  • The highest dose of DuoCAR20.19.22-D95 that's safe to give
  • If DuoCAR20.19.22-D95 is safe and works well to treat B-ALL or B-NHL 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 that has relapsed or is refractory:
    • B-ALL
    • B-NHL. Some examples include:
      • Diffuse large B-cell lymphoma (DLBCL)
      • Follicular lymphoma
      • High-grade B-cell lymphoma
      • Primary cutaneous DLBCL
      • Primary mediastinal large B-cell lymphoma
  • Have cancer cells with one or more of the following mutations (your doctor can tell you this):
    • CD19
    • CD20
    • CD22
  • Do not have lymphoma in your brain or spinal cord
  • Have not had CAR T-cell therapy 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.
Cyclophosphamide and fludarabine are chemotherapy (chemo) drugs that block the growth of cancer cells.
DuoCAR20.19.22-D95 is a type of CAR T-cell therapy that targets CD19, CD20 and CD22 on certain cells

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 chemo with 2 standard drugs:
  • Cyclophosphamide – Given as intravenous (IV) infusions 4 times
  • Fludarabine –  Given as IV infusions 2 times

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 1 year. You'll have scans 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 DuoCAR20.19.22-D95. 

Watch a video about CAR T-Cell Therapy

Locations


University of Kansas Cancer CenterRECRUITING

Westwood, Kansas
Contacts:

ClinicalTrials.gov record


NCT06879340. First posted on Mar 17

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