Clinical Trial Goal
To find out if ATLCAR.CD30 is safe and works well to treat PTCL that has relapsed or is refractory
You may be able to join this trial if you:
- Are 18 years old or older
- Have PTCL that has relapsed or is refractory
- Have had at least 2 different treatments for the lymphoma
- Have lymphoma cells with CD30 markers. Your doctor can tell you this
- Do not have cutaneous T-cell lymphoma
- 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. ATLCAR.CD30 are T cells that are made to target CD30 on certain cells.
Bendamustine, cyclophosphamide and fludarabine are chemotherapy (chemo) drugs that block the growth of cancer cells.
To make ATLCAR.CD30, 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. ATLCAR.CD30 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 ATLCAR.CD30 infusion, you’ll get chemo with 2 or 3 standard drugs:
Bendamustine, cyclophosphamide and fludarabine are chemotherapy (chemo) drugs that block the growth of cancer cells.
To make ATLCAR.CD30, 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. ATLCAR.CD30 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 ATLCAR.CD30 infusion, you’ll get chemo with 2 or 3 standard drugs:
- Bendamustine – Given as intravenous (IV) infusions 1 time each day for 3 days. Each infusion takes 1 hour
- Cyclophosphamide – Given as IV infusions 1 time each day for 3 days. Only people who get a second infusion of ALTCAR.CD30 cells get this
- Fludarabine – Given as IV infusions 1 time each day for 3 days. Each infusion takes 30 minutes
Then, the ATLCAR.CD30 are given to you through up to 2 IV infusions. The infusion takes about 10 minutes. The dose of cells you’ll get depends on when you start the trial and how safe it’s been.
The clinical trial doctors will watch you closely over the first 24 hours. You’ll have scans to see how well 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 this kind of CAR T cell to treat PTCL that has relapsed or is refractory.
Watch a video about CAR T cell therapy
Contacts
Lori Stravers, 919-966-4432, UNCImmunotherapy@med.unc.edu
Shamina Williams, 919-966-4432, UNCImmunotherapy@med.unc.edu
Locations
Lineberger Comprehensive Cancer Center at University of North CarolinaRECRUITING
Chapel Hill, North Carolina
Contacts:
- Catherine Cheng, 919-445-4208, UNCImmunotherapy@med.unc.edu
- Caroline Babinec, 919-962-7426, UNCImmunotherapy@med.unc.edu
Wake Forest Baptist Medical CenterRECRUITING
Winston-Salem, North Carolina
Contacts:
- Jana Hall Project Manager, 919-966-4432, UNCImmunotherapy@med.unc.edu
- Caroline Jones Dinkins, 919-966-4432, UNCImmunotherapy@med.unc.edu
Sponsors
lead: UNC Lineberger Comprehensive Cancer Center
