Chimeric Therapeutics Ltd (ASX:CHM) has the ethics review board’s green light to initiate a multi-site Phase 1B clinical trial of CHM 1101 in patients with recurrent and/ or progressive glioblastoma multiforme (GBM).
The company sees this as a new chapter in the development of CHM 1101, which will see Chimeric rolling the two-part Phase 1B clinical study across multiple trial sites.
Two-part trial
Part A of the trial will treat three to six patients, wrapping up the Phase 1 CHM 1101 dose escalation/confirmation study started at City of Hope Cancer Center.
At the end of 2023, clinicians will conduct an assessment of clinical safety and efficacy data from the Phase 1 dose escalation/confirmation cohort. If the results of that assessment prove positive, Part B of the trial design will go ahead.
Part B of the trial is a dose expansion cohort designed to enrol between 12 and 26 patients with recurrent and/or progressive GBM using the recommended Phase 2 dosing plan and assessing for efficacy and safety.
Once the Part B dose expansion cohort is complete, a registration trial will be initiated in alignment with regulatory feedback.
Expanding clinical program
“Expanding our clinical program to additional sites is critical to our mission to deliver our medicines to the patients who need them,” said chief medical officer Dr Jason Litten.
“The two-part trial design also ensures that we are positioned to move rapidly into the dose expansion cohort upon a positive clinical assessment of the Phase 1 data at the end of 2023.”
The company will present additional details of its CHM Phase 1B trial design and objectives at the American Society of Clinical Oncology (ASCO) annual meeting as part of the Central Nervous System Tumors section on June 3, 2023.
About CHM 1101
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, patients who have a poor prognosis, with limited treatment options and a median survival of less than one year.
CHM 1101 cells uniquely use chlorotoxin (CLTX), a 36-amino acid peptide derived from deathstalker scorpion venom, as the tumour-targeting component of the chimeric antigen receptor (CAR).
In preclinical models, CHM 1101 CAR T cells have been shown to bind more broadly and specifically to GBM cells than other targeting domains like EGFR, HER-2 or IL-13.
CHM 1101 cells also demonstrated potent antitumour activity against glioblastoma while not exhibiting any off-tumour recognition of normal human cells and tissues, indicating a potentially optimal safety and efficacy profile.
CHM 1101 is being studied in an ongoing phase 1A clinical trial in recurrent/progressive glioblastoma at City of Hope Cancer Centre in California. Outcomes from the initial two dose levels of the Phase 1A trial have been previously presented and demonstrated patient safety with a disease stability rate of around 70%.