Chimeric Therapeutics (ASX:CHM) is celebrating the successful treatment of the third participant, required to complete the fourth and final planned dose escalation cohort, in a Phase 1A dose escalation study being conducted at City of Hope evaluating the safety and maximum tolerated dose of Chimeric’s CHM 1101 in patients with recurrent or progressive glioblastoma (GBM).
Chimeric Therapeutics has licensed the exclusive global rights to intellectual property covering the chlorotoxin CAR-T cells from City of Hope, one of the largest cancer research and treatment organizations in the United States. Behnam Badie, M.D., City of Hope Chief of Division of Neurosurgery, is the trial’s principal investigator. The trial has been conducted at City of Hope’s Los Angeles campus.
The Phase 1A study enrolled clinical trial participants with MMP2+ recurrent or progressive GBM across four dose levels. Study objectives were to evaluate the safety and efficacy of CLTX CAR T and to establish recommended dosing for a Phase 2 trial. Participants at this dose level received a total dose of 440 X 106 CHM 1101 (CLTX CAR T) cells through dual routes of intratumoral and intraventricular administration.
“We are very pleased that the Phase 1A City of Hope clinical trial has completed dose escalation at all four planned dose levels,” said Jennifer Chow, CEO and Managing Director of Chimeric Therapeutics. “We look forward to providing an update on the safety and efficacy from the trial before the end of the year.”
Chimeric has now advanced development of CHM 1101 to a Phase 1B clinical trial currently open for enrolment at the Sarah Cannon Transplant & Cellular Therapy Program at St. David’s South Austin Medical Centre in Austin, Texas.
The trial is being conducted under a US IND and 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 clinical trial participants at the highest dose tested in the Phase 1A clinical trial at City of Hope.
In late 2023, Chimeric will provide an update on the clinical safety and activity from the CHM 1101 clinical program. Based on a favourable review of the results of that assessment, Part B of the trial, a dose expansion cohort, will be opened to enrol 12 to 26 additional participants.
Upon successful completion of the Part B dose expansion cohort, the Company intends to design and initiate a registrational trial, in alignment with regulatory guidance and feedback.
