Chimeric Therapeutics Ltd (ASX:CHM) passed a key milestone by completing the second dose cohort in the Chlorotoxin CAR T (CLTX CAR T) phase 1 dose-escalation study at the City of Hope, a world-renowned cancer research and treatment organisation near Los Angeles.
Notably, all patients in the second dose cohort were dosed with a total dose of 88 X 106 CLTX CAR T cells (double that used in the first dose cohort) and have now advanced past the 28-day follow up period without experiencing any dose-limiting toxicities.
Looking ahead, the study now advances to the third dose cohort, which will administer CLTX CAR T cells to patients through the dual routes of administration at an increased total dose of 220 X 106 CLTX CAR T cells.
“Important milestone”
Chimeric CEO Jennifer Chow said: “Chimeric is incredibly pleased to have reached this important milestone with our CLTX CAR T cell therapy.
“Demonstrating safety with dual routes of administration (ICT and ICV) at this 2nd CLTX CAR T dose level is very encouraging.
“We now look forward to further advancing the development of CLTX CAR T as we enter the 3rd dose level in the trial.”
About CLTX CAR T clinical trial
The CLTX CAR T phase 1 clinical trial is in progress at a single site in California with plans to expand to a multi-site trial in 2022.
The primary endpoints of the trial are to assess the safety of CLTX CAR T cells, determine the maximum tolerated dose schedule and a recommended Phase 2 dosing plan.
This trial is designed with four dose levels ranging from 44 X 106 to 440 X 106 CLTX CAR T cells and studies both single and dual routes of administration of cells.
About Chlorotoxin Car T
Chlorotoxin CAR T (CLTX CAR T) cell therapy is the first and best in class CAR T cell therapy which has the potential to address the high unmet medical need of patients with recurrent/ progressive glioblastoma.
CLTX CAR T cell therapy uniquely utilises 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.