Chimeric Therapeutics (ASX:CHM) has announced that the CHM CDH17 clinical trial has advanced to Dose Level 2, following the observation of no safety concerns or off-target effects at Dose Level 1.
The company stated that Dose Level 1 tested 50 million CHM CDH17 CART+ cells in clinical trial subjects, providing early signs of activity and a compelling safety profile. Specifically, there were four subjects treated, three with colorectal cancer (CRC) and one with an intestinal neuroendocrine tumour (NET). In this group of advanced cancer patients, no dose-limiting toxicities or unexpected safety findings were reported, said Chimeric.
One patient experienced Grade 1 cytokine release syndrome (CRS) 10 days after receiving CHM CDH17 that was associated with peripheral CART+ cell expansion and persistence.
"Chimeric is encouraged by these safety findings and early signs of clinical activity with one NET patient experiencing stable disease for five months and one CRC patient with stable disease that is ongoing at four months," said the company.
"The emergence of CRS, a hallmark of CAR-T cell expansion, is an indication that CHM CDH17 is engaging patients’ immune systems and highlights its potential as a transformative new medicine for cancer patients," it said.
Under Dose Level 2, 150 million CHM CDH17 CART+ cells will be administered in a single dose.
“This represents a major milestone for Chimeric as we continue to build momentum and deliver on the promise of our technology,” said Dr Rebecca McQualter, CEO of Chimeric Therapeutics.
