Sino-US firm Innovative Cellular Therapeutics (ICT) announced the involvement of the first subject in a US-based Phase I clinical study for its GCC19CART, a CoupledCAR-based cell therapy, in relapsed / refractory metastatic colorectal cancer (R / R mCRC). The subject has completed apheresis, with cells successfully produced.
Study Details
The open-label, single-arm, multi-center, Phase I dosage escalation study (NCT05319314) is designed to assess the safety, tolerability, and efficacy of GCC19CART in US patients with R / R mCRC. The study was approved in August 2021.
Previous Results
GCC19CART has achieved major breakthroughs in a domestic investigational clinical study in third-line and above mCRC in China. Among 35 patients with advanced colorectal cancer, the medium-dose group objective response rate (ORR) of the dose-escalation trial reached 50%. In contrast, the two third-line colorectal cancer drugs approved by the US FDA, regorafenib and trifluridine / tipiracil, produced a respective 1% and 1.6% ORR. The median overall survival (mOS) of the middle-dose group of the GCC19CART dose-escalation trial has exceeded 14 months, with the vast majority of patients still alive. This indicates that the mOS will still be significantly prolonged, and the treatment effect is significantly better than the FDA-approved standard third-line therapies (mOS, 6-8 months). Additionally, the progression-free survival (PFS) of GCC19CART has exceeded six months. The product obtained fast-track designation status in the US in April this year.-Fineline Info & Tech
