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Innovative Cellular Therapeutics Gets FDA Clearance to Start Phase I Trial of CAR T-Cell Therapy in US

NEW YORK – Innovative Cellular Therapeutics said on Thursday that the US Food and Drug Administration has cleared an investigational new drug application for its CAR T-cell therapy GCC19CART, allowing for the start of a Phase I clinical trial of the treatment in relapsed or refractory metastatic colorectal cancer patients whose tumors express the target antigen guanylate cyclase 2C (GCC or GUCY2C).

Rockville, Maryland-based ICT said in a statement it will begin the trial during the first half of 2022.

ICT will develop GCC19CART in house using its CoupledCAR platform, which is designed to optimize target selection and enhance the efficacy of CAR T cells. The firm has begun evaluating the therapy in several solid tumor indications in China, including colorectal cancer and thyroid cancer patients.

"This IND clearance builds upon the promising clinical data generated by our team in Shanghai demonstrating objective responses with manageable expected toxicity when administered to heavily pretreated colorectal cancer patients as single-agent experimental therapy," Eugene Kennedy, ICT's chief medical officer, said in a statement. "I look forward to advancing this program in the US while we continue to develop proof-of-concept data for additional solid tumor indications."