Clinical Trial Goal
To find out:
- The highest dose of Senza5 that's safe to give
- If Senza5 safe and works well to treat T-NHL with CD5 mutation that has relapsed or is refractory
You may be able to join this trial if you:
- Are 18 years or older
- Have T-NHL that has relapsed or is refractory
- Have cancer cells with a CD5 mutation. Your doctor can tell you this
- Do not have lymphoma in your brain or spinal cord
- Have not had any of the following in the last 3 months:
- Autologous (your own cells) blood or marrow transplant (BMT)
- CAR T cell therapy
- 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.
Senza5 is a type of CAR T cell therapy that targets CD5 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 chemotherapy (chemo) with 2 of standard drugs:
Senza5 is a type of CAR T cell therapy that targets CD5 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 chemotherapy (chemo) with 2 of standard drugs:
- Cyclophosphamide – Given as intravenous (IV) infusions 3 times
- Fludarabine – Given as IV infusions 3 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 Senza5.
Watch a video about CAR T-Cell Therapy
Locations
Columbia University Irving Medical CenterRECRUITING
New York, New York
Clinical Protocol and Data Management Office, 212-342-5162, cancerclinicaltrials@cumc.columbia.edu
University of Pennsylvania - Abramson Caner CenterRECRUITING
Philadelphia, Pennsylvania
Contacts:
- Brittany J Koch - Program Manager, Lymphoma Clinical Research, MPH, CCRP, 215-776-5548, Brittany.Koch@pennmedicine.upenn.edu
- Michael McNicholas - Clinical Trial Nurse, MBA, MSN, OCN, RN, 267-804-4081, michael.mcnicholas@pennmedicine.upenn.edu
Sponsors
collaborator: University of Pennsylvania, lead: Vittoria Biotherapeutics
