Cell therapy company Chimeric Therapeutics (ASX:CHM) has announced the completion of Good Manufacturing Practice (GMP) manufacturing to enable the treatment of the first clinical participant in the CHM CDH17 CAR-T trial.
The cells of the trial participants were collected at Sarah Cannon Cancer Centre in Nashville, Tennessee, and transported to the contract manufacturing site.
The company said that following GMP manufacturing, the CHM CDH17 CAR-T cells passed specification testing and quality Assurance review and are in transit back to the clinical trial site for infusion.
“We are delighted to have a successful manufacturing run for our first clinical trial participant; This milestone is the culmination of more than two years of focused effort to develop and implement a GMP compliant manufacturing process to support this patient population in need of new treatment options.” said Dr Kelly Thornburg, Chimeric Therapeutics head of technical operations.
The Phase 1/2 trial (NCT06055439) is a two-stage study designed to determine a recommended Phase 2 dose of CHM CDH17 and evaluate its safety and objective response rate in participants with advanced colorectal, gastric, and intestinal neuroendocrine tumours.
The company said additional clinical trial sites are anticipated to open in the second half of 2024.