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Locally made CAR T cells to treat B-cell lymphoma and acute lymphoblastic leukemia (ALL) that has come back (relapsed) or has not gotten better with treatment (refractory)

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18 - 79

Phase 2

1 Location

NCT05281809

Clinical Trial Goal


To find out if CAR T-cells made locally with the CliniMACS Prodigy device are safe and work well to treat B-cell lymphoma and ALL that has relapsed or is refractory

You may be able to join this trial if you:


  • Are 18 – 79 years old
  • Have B-cell lymphoma or ALL that has relapsed or is refractory. Some examples include:
    • Chronic lymphocytic leukemia (CLL)
    • Diffuse large B-cell lymphoma (DLBCL)
    • Follicular lymphoma
    • Lymphoplasmacytic lymphoma
    • Mantle cell lymphoma
    • Marginal zone lymphoma
  • Have cancer cells with CD19 marker. Your doctor can tell you this
  • Do not have untreated cancer cells in your brain or spinal cord 
  • 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 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 chemotherapy (chemo) with standard drugs.

Then, the CAR T cells are given to you through an IV infusion.

The clinical trial doctors will watch you closely over 2 weeks. 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 15 years.

The Food and Drug Administration (FDA) has approved CAR T-cell therapy to treat certain blood cancers. Making the CAR T cells locally with the CliniMACS Prodigy device is new and unproven.

Watch a video about CAR T-Cell Therapy 

Contacts


John Lister, MD, 412-578-4484, john.lister@ahn.org

Locations


AHN Cancer Institute - West Penn HospitalRECRUITING

Pittsburgh, Pennsylvania
Contacts:

  • John Lister, MD, 4125784484, john.lister@ahn.org
  • AHN Clinical Trials Contact, 412-330-6011, clinicaltrials@ahn.com
  • Cyrus Khan, MD
  • Salman Fazal, MD
  • Anna Koget, DO
  • Prerna Mewawalla, MD
  • Santhosh Sadashiv, MD
  • Yazan Samhouri, MD
  • Thomas Curley, MD

ClinicalTrials.gov record


NCT05281809. First posted on 3/16/22

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