On December 17, 2021 Chimeric Therapeutics (ASX:CHM, "Chimeric"), a clinical-stage cell therapy company and the ASX leader in cell therapy, reported the successful completion of the 2nd dose cohort in the CLTX CAR T phase 1 dose escalation study at the City of Hope, a world-renowned cancer research and treatment organization near Los Angeles (Press release, Chimeric Therapeutics, DEC 17, 2021, View Source [SID1234597356]).
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All patients in the 2nd 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.
The successful completion of this 2nd patient cohort is a significant milestone for CLTX CAR T cell therapy as the 2nd dose cohort introduced dual routes (intraventricular and intratumoral) of CLTX CAR T administration.
The study now advances to the 3rd 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.
"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," said Jennifer Chow, Chimeric Therapeutics Chief Executive Officer.
About the CLTX CAR T (CHM1101) Clinical Trial:
The CLTX CAR T phase 1 clinical trial is currently in progress at a single site in California with plans to expand to a multi-site trial in 2022. The design is a single arm trial in patients with MMP2+ recurrent or progressive glioblastoma.
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. Secondary endpoints include bioactivity and efficacy measures.
The trial is designed with 4 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. Dose level 1 was completed with no dose limiting toxicities in April 2021. Authorised on behalf of the Chimeric Therapeutics board of directors by Chairman Paul Hopper.
ABOUT CHLOROTOXIN CAR T
Chlorotoxin CAR T (CLTX CAR T) cell therapy is a first and 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-tumor recognition of normal human cells and tissues, indicating a potentially optimal safety and efficacy profile