BioSpace News Archive

Drug Development

Carina Biotech Receives FDA “Safe to Proceed” Letter for IND Application for Phase 1/2a Clinical Trial of LGR5-Targeted CAR-T Cell Therapy Candidate for Treatment of Advanced Colorectal Cancer

Carina Biotech Pty Ltd (“Carina,” “the Company”) announced today that it has received the “safe to proceed” letter from the U.S. FDA for its Investigational New Drug (NDA) application to conduct a first-in-human Phase 1/2a clinical trial of CNA3103, its LGR5-targeted chimeric antigen receptor T cell (CAR-T) therapy candidate, in patients with advanced colorectal cancer (CRC).

January 23, 2023
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5 min read