On December 22, 2022 Chimeric Therapeutics, a clinical stage cell therapy company and an Australian leader in cell therapy, reported the successful completion of the planned dosing of the third patient cohort (n=3) in the Phase 1 dose escalation study evaluating the safety and maximum tolerated dose of Chimeric’s CHM 1101 (CLTX CAR T) cell therapy, in patients with recurrent or progressive glioblastoma (GBM) (Press release, Chimeric Therapeutics, DEC 22, 2022, View Source [SID1234625531]).
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The Phase 1A CHM 1101 clinical trial is taking place at City of Hope, one of the largest cancer research and treatment organizations in the United States. Chimeric Therapeutics has licensed the exclusive global rights to intellectual property covering the chlorotoxin CAR-T cells from City of Hope. Behnam Badie, M.D., City of Hope Chief of Division of Neurosurgery, is the trial’s principal investigator.
The Phase 1A study aims to enroll 18-36 patients with MMP2+ recurrent or progressive GBM across 4 dose levels. Study objectives are to evaluate the safety and efficacy of CLTX CAR T and to establish recommended dosing for a Phase 2 trial.
Patients (n=3) in this third dose level received a total dose of 240 X 106 CHM 1101 (CLTX CAR T) cells through dual routes of intratumoral and intraventricular administration.
Once the final evaluable patient of this third dose cohort successfully completes the 28 DLT period, the study will be able to advance to recruitment of patients at the fourth and final planned dose level of 440 X 106 CHM 1101 (CLTX CAR T) cells through dual routes of administration (intratumoral and intracranial intraventricular).
About CHM 1101 (Chlorotoxin CAR T):
CHM 1101, Chimeric’s Chlorotoxin CAR T (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/ progressive glioblastoma.
CHM 1101 uniquely utilizes chlorotoxin (CLTX), a peptide derived from scorpion toxin, as the tumour-targeting component of the chimeric antigen receptor (CAR) which has 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 also demonstrated potent antitumor activity against glioblastoma while not exhibiting any off-tumor recognition of normal human cells/tissues, supporting a potentially optimal safety and efficacy profile.