Clinical Trial Goal
To find out:
- The highest dose of CAR T cells (CD4CAR) that's safe to give
- If CD4CAR CAR T cells are safe and work well to treat CMML that has relapsed or is refractory
You may be able to join this trial if you:
- Are 18 years old or older
- Have CMML that has relapsed or is refractory
- Have cancer cells with a CD4 marker (CD4+). Your doctor can tell you this
- Have not been treated with CAR T-cell or gene therapy before
- 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 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 month. You'll have biopsies to see how well the treatment is working. The clinical trial doctors will check your health for 15 years.
The Food and Drug Administration (FDA) has not yet approved CD4CAR CAR T cells.
Watch a video about CAR T-Cell Therapy
YMVkPF1tUG8
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 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 month. You'll have biopsies to see how well the treatment is working. The clinical trial doctors will check your health for 15 years.
The Food and Drug Administration (FDA) has not yet approved CD4CAR CAR T cells.
Watch a video about CAR T-Cell Therapy
YMVkPF1tUG8
Contacts
Cristina Roach, RN, 317-274-0840, jeschwar@iu.edu
Jennifer Schwartz, MD, PhD, 317-274-0840, jeschwar@iu.edu
Locations
University of Miami Sylvester Comprehensive Cancer Center, Miami, Florida 33136RECRUITING
Miami, Florida
Contacts:
- Amer Beitinjaneh, MD, 305-243-9127, abeitinjaneh@miami.edu
- Anakrystine Vallin, 305-243-3450, axv1336@med.miami.edu
Indiana University Melvin and Bren Simon Comprehensive Cancer CenterRECRUITING
Indianapolis, Indiana
Contacts:
- Cristina Roach, RN, 317-274-0840, jeschwar@iu.edu
- Jennifer Schwartz, MD, 317-278-9504, jeschwar@iu.edu
Albert Einstein Health NetworkNOT_YET_RECRUITING
The Bronx, New York
Joel Victor, BA, 718-920-6680, jovictor@montefiore.org
The University of Texas MD Anderson Cancer CenterRECRUITING
Houston, Texas
Brianna Kammerer, RN, 832-270-9423, bekammerer@mdanderson.org
Sponsors
collaborator: iCell Gene Therapeutics, collaborator: The Leukemia and Lymphoma Society, lead: Huda Salman
