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Innovative Cellular Therapies Begins Trial of Autologous CAR T-Cell Therapy in Colorectal Cancer

NEW YORK – Innovative Cellular Therapeutics on Thursday said it has enrolled the first colorectal cancer patient to a Phase I trial of its investigational cell therapy GCC19CART. 

The Rockville, Maryland-based firm is evaluating its autologous CAR T-cell therapy in 30 patients with relapsed or refractory metastatic colorectal cancer whose tumors are positive for guanylate cyclase (GCC) as determined by immunohistochemistry. The cell therapy is also designed to target GCC. 

The primary goal in the study, dubbed CARAPIA-1, is to evaluate safety and tolerability, and determine the recommended Phase II dose. Researchers will also measure preliminary efficacy such as overall response rate, duration of response, and progression-free survival as secondary endpoints. 

GCC19CART is designed using Innovative Cellular Therapeutics' CoupledCAR technology, which the firm hopes can overcome the challenges of treating solid tumors with CAR T-cell therapy by improving T-cell proliferation and tumor infiltration. The company said the treatment demonstrated promising activity in a proof-of-concept clinical study in China. 

Innovative Cellular Therapeutics is starting the CARAPIA-1 trial after the US Food and Drug Administration cleared its investigational new drug application in September.