Chimeric Therapeutics announced activation of a Phase 1B clinical trial in patients with recurrent and/or progressive glioblastoma multiforme (GBM) to assess the safety and efficacy of CHM 1101, the company's first in class CLTX CAR T cell therapy. 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.

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. CHM 1101 (CLTX CAR T) is a first-in-class CAR T therapy that has the potential to address the high unmet medical need of patients with recurrent or progressive glioblastoma.

Research to develop the intellectual property covering this CAR T cell therapy took place at City of Hope. CHM 1101 cells uniquely utilize chlorotoxin (CLTX), a peptide component of scorpion venom, as the tumor-targeting component of the chimeric antigen receptor (CAR). CHM 1101 CAR T cells have been shown in preclinical models to bind more broadly and specifically to GBM cells than other targeting domains like EGFR, HER-2 or IL-13.

In preclinical models, CHM 1101 cells also demonstrated potent antitumor activity against glioblastoma while not exhibiting any off-tumor recognition of normal human cells and tissues, indicating a potentially optimal safety and efficacy profile. CHM 1101 is currently being studied in a Phase 1B clinical trial in recurrent /progressive glioblastoma. Initial positive data from the investigator-initiated Phase 1A trial has been presented on patients treated in the first two dose levels of the trial.