Chimeric Therapeutics Ltd (ASX:CHM), the only clinical-stage cell therapy company on the ASX, is set to begin a Phase 1B clinical trial to test the safety and efficacy of its first-in-class CLTX CAR T cell therapy, CHM 1101, in patients with recurrent or progressive glioblastoma multiforme (GBM).
GBM is known as the most common and deadly primary brain cancer, with only a 6.8% five-year survival rate and an average life expectancy of about eight months.
The trial is now open for enrolment at the Sarah Cannon Transplant & Cellular Therapy Program at St David’s South Austin Medical Center in Austin, Texas.
New chapter in CHM 1101 development
“We are very excited to be activating the first site in our CHM 1101 Phase 1B clinical trial as it marks a new chapter in the development of CHM 1101,” Chimeric Therapeutics CEO and managing director Jennifer Chow said.
“This multi-centre trial will enable us to more rapidly advance the development of CHM 1101 with recruitment across multiple clinical trial sites and also prepare us to accelerate the next phase of development if supported by the clinical results.”
In late 2023, Chimeric will assess the clinical safety and activity from the CHM 1101 clinical program.
Should the review of results be favourable, Chimeric will open Part B of the trial, a dose expansion cohort, to enrol 12 to 26 additional patients.
Upon successful completion of Part B, the company plans to design and initiate a registration trial, in consultation with global regulatory feedback.
“We’re very pleased to be building upon the City of Hope investigator-initiated trial and advancing CHM 1101 to a multi-centre clinical trial,” Chimeric chief medical officer Jason B Litten MD said.
“GBM continues to represent an important unmet medical need and the early clinical results from the City of Hope trial provide support that CHM 1101 may improve outcomes for GBM patients.”