Clinical stage cell therapy company Chimeric Therapeutics (ASX:CHM) has confirmed that all patients dosed in the first patient cohort in City of Hope’s phase 1 CLTX CAR T cell clinical trial have now advanced beyond the 28-day follow up period without experiencing dose-limiting toxicities.
Achievement of this safety milestone for all patients in cohort 1 enables the trial to advance to the second dosing level, which will administer CLTX CAR T cells by two routes (intratumoral (ICT) and intracranial intraventricular (ICV)) at a total dose of 88 x 106 CAR T cells.
The CLTX CAR T cell clinical trial is taking place at City of Hope, a world-renowned cancer research and treatment center near Los Angeles.
As all patients in the initial dose cohort have now passed the 28-day follow up period without experiencing dose limiting toxicities, the trial is now able to advance to the second dose level.
Initiation of dosing at the second dose level will introduce administration by two routes (intratumoral (ICT) and intracranial intraventricular (ICV)) at a total dose of 88 x 106 CAR T cells, and will enable patient dosing without a mandated stagger.
Chairman, Paul Hopper, said the objective of this study is to evaluate the safety and maximum tolerated dose of Chimeric’s Chlorotoxin CAR T (CLTX CAR T) cell therapy in patients with recurrent or progressive glioblastoma (GBM).
The Phase 1 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 cells and to establish recommended dosing for a phase 2 trial.
We are very pleased to have reached this significant milestone with our CLTX CAR T cell therapy as it enables us to advance the development of this important therapy for patients with progressive or recurrent Glioblastoma,” Mr Hopper said.
Chlorotoxin CAR T (CLTX CAR T) cell therapy is a first and potentially best in class CAR T cell therapy that has the potential to address the high unmet medical need of patients with recurrent/ progressive glioblastoma. Research to develop the intellectual property covering this CAR T cell therapy took place at City of Hope.
CLTX CAR T cell therapy uniquely utilizes chlorotoxin (CLTX), a peptide derived from scorpion toxin, as the tumour- targeting component of the chimeric antigen receptor (CAR). CLTX and CLTX 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, CLTX CAR T cells also demonstrated potent antitumor activity against glioblastoma while not exhibiting any off-tumour recognition of normal human cells and tissues, indicating a potentially optimal safety and efficacy profile.