FDA clears IND application for CAR-T to treat metastatic colorectal cancer
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The FDA cleared an investigational new drug application for GCC19CART, a chimeric antigen receptor T-cell therapy designed to treat patients with relapsed or refractory metastatic colorectal cancer.
GCC19CART (Innovative Cellular Therapeutics) is an autologous, gene-edited CAR T-cell therapy that targets the enzyme guanylate cyclase 2C (GCC) on the surface of cancer cells.
The agent is manufactured using ICT’s proprietary CoupledCAR technology to improve CAR T-cell efficacy in solid tumors.
The IND clearance will allow the company to start enrollment of a clinical trial that will evaluate GCC19CART for patients with relapsed or refractory metastatic colorectal cancer. The phase 1 CARAPIA-1 trial should begin by the first half of 2022, according to an ICT-issued press release.
A pilot study conducted in China evaluated GCC19CART for seven patients with relapsed or refractory colorectal cancer whose disease progressed after multiple rounds of chemotherapy and radiotherapy.
The results — presented at this year’s virtual AACR Annual Meeting — showed evidence of clinical response among four patients (57.1%). One patient achieved complete response to the novel CAR T-cell therapy.
“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 [patients with] heavily pretreated colorectal cancer as single-agent experimental therapy,” Eugene Kennedy, MD, chief medical officer of ICT, said in the release. “I look forward to advancing this program in the U.S. while we continue to develop proof-of-concept data for additional solid tumor indications.”
Reference:
Xiao L, et al. Abstract LB146. Presented at: American Association for Cancer Research Annual Meeting (virtual meeting); April 10-15, 2021.
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