Participate in Research at CU Anschutz

Study ICT-GCC19CART-US-001 (CARAPIA-1) is a Phase 1 study evaluating the safety, tolerability, clinical activity, pharmacokinetics and pharmacodynamics of GCC19CART in subjects with relapsed or refractory metastatic colorectal cancer. Primary 1. To evaluate the safety of GCC19CART in adult subjects with relapsed or refractory metastatic colorectal cancer 2. To obtain maximum tolerable dose (MTD) and the recommended phase 2 dose (RP2D)

This study plans to learn more about an investigational drug, GCC19CART. “Investigational” means that the study drug has not been approved by the U.S. Food and Drug Administration (FDA). This research study is a Phase I clinical trial, which tests the safety of an investigational drug and also tries to find the dose of the investigational drug to use for further studies. The U.S. Food and Drug Administration (FDA) has not approved GCC19CART as a treatment for any disease. This is the first time that GCC19CART will be given to humans in the United States. A small number of patients outside of the United States has been treated with GCC19CART in an early phase study. In this research study, we are working to see if GCC19CART is effective and safe to treat your colorectal cancer. GCC19CART is a type of immunotherapy known as chimeric antigen receptor (CAR) T cell therapy. Immunotherapy uses a participant’s own immune system to fight cancer. GCC19CART is being developed by Innovative Cellular Therapeutics. Currently your T cells (part of your immune cells) are not able to recognize or attack the cancer cells. GCC19CART therapy modifies your own T cells so that they can recognize and attack your cancer cells. Some colorectal cancer cells can be identified by a protein called GCC which is present on the surface of these cells. In this study, your immune cells will be collected from your blood in a procedure called leukapheresis. The T cells will be separated from the collected immune cells and will be modified in a laboratory. In the laboratory, new genes will be put into your T cells using genetic modification techniques. After they have been modified, the cells will be grown in the laboratory to reach the expected dose for the treatment. Adding in the new genes may enable your T cells (now called GCC19CART cells) to bind to the GCC protein, which your type of cancer cells carry on their surface. Binding to these GCC carrying tumor cells activates the GCC19CART cells, and they attack the cancer cells. The GCC19CART cells will be given back to you through an infusion into your vein. The modified T cells (GCC19CART cells) that are given back to you are now the investigational product because the modified T cells are no longer considered your original T cells. The GCC19CART cells will stay in your body after attacking the cancer cells. You will be monitored during the study to evaluate how long these GCC19CART cells stay in your body. You are being asked to be in this research study because you have colorectal cancer that has spread and is not responding to standard treatment.