• New CHM 1101 (CLXT CAR T) multi-center clinical trial activated at Sarah Cannon Research Institute (SCRI) in Austin, Texas
• Enrolment now open to patients with recurrent and/or progressive glioblastoma multiforme (GBM), the most common and most deadly primary brain cancer

The trial is now open for enrollment at the Sarah Cannon Transplant & Cellular Therapy Program at St. David’s South Austin Medical Center in Austin, Texas.

“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,” said Jennifer Chow, CEO and Managing Director of Chimeric Therapeutics. “This multi-center 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.”

This Phase 1B trial, being conducted under a US IND, is a two-part clinical trial designed to determine a recommended Phase 2 dose and administration schedule. Part A of the trial will enroll 3-6 patients at the highest dose tested in the ongoing clinical trial at City of Hope Cancer Centre.

In late 2023, Chimeric will assess the clinical safety and activity from the CHM 1101 clinical program. Based on a favorable review of the results of that assessment, Part B of the trial, a dose expansion cohort, will be opened to enroll 12 to 26 additional patients.

Upon successful completion of the Part B dose expansion cohort, the Company intends to design and initiate a registration trial, in collaboration 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-center clinical trial. 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,” said Jason B Litten MD, Chief Medical Officer, Chimeric Therapeutics.

CHM 1101 demonstrated safety with ~70% disease stability in the initial two dose cohorts in the City of Hope Phase 1A investigator-initiated clinical trial.

Additional details on the CHM Phase 1B trial design and objectives were presented on June 3 at the American Society of Clinical Oncology (ASCO) annual meeting as part of the Central Nervous System Tumors section as abstract TPS2086/Poster 440a, “Phase 1B multicenter study to evaluate CHM 1101 in patients with recurrent or progressive glioblastoma”.