- Chimeric Therapeutics has completed the follow-up period for the first patient cohort in CLTX CAR T Phase 1 clinical trial.
- After the significant safety milestone for the CLTX CAR T cell therapy, the Company will advance to the second dosing level.
- In the second cohort, CLTX CAR T cells will be administered by ICT (intratumoral) and ICV (intracranial intraventricular) routes at a higher dose.
ASX-listed developer of ground-breaking CAR T cell therapies Chimeric Therapeutics Limited (ASX:CHM) announced that it has successfully completed a 28-day follow-up for the first patient cohort in CLTX CAR T Phase 1 clinical trial.
The biotechnology firm confirmed that all patients dosed in the first patient cohort in Phase 1 CLTX CAR T cell clinical trial at City of Hope had advanced beyond the follow-up period without suffering any dose-limiting toxicities.
The revolutionary CLTX CAR T therapy, which uses chlorotoxin - a peptide derived from scorpion toxin – is being trialled for the treatment of patients with progressive or recurrent glioblastoma (GBM).
CHM to advance CLTX CAR T trial to second dosing level
Having achieved the significant safety milestone for CLTX CAR T cell therapy, the Company will now advance the trial to the second dosing level.
In this cohort, CLTX CAR T cells will be administered by ICT (intratumoral) and ICV (intracranial intraventricular) routes at a total dose of 88 x 106 CAR T cells.
Dose escalation in CLTX CAR T Phase 1 trial, Source: CHM Presentation (18 March 2021)
Commenting on the significant development, COO Jennifer Chow said:
CLTX CAR T Phase 1 Trial Background
The CLTX CAR T clinical trial is being conducted at City of Hope, a prominent cancer research and treatment centre in California, US.
Chimeric Therapeutics announced the successful completion of dosing of the first patient cohort in Phase 1 dose-escalation study in March 2021. At that time, the Company observed that all patients in the cohort would have to complete a 28-day follow-up monitoring period for dose-limiting toxicities before advancing to the next dose level of the study.
The Company also disclosed that the trial can now advance to the second dose level as all the patients in the first cohort had passed the follow-up period without any dose-limiting toxicities.
The initiation of the second cohort will introduce administration by ICT and ICV routes at a dose of 88 x 106 CAR T cells. Moreover, this will facilitate patient dosing without a mandated stagger.
- The study will evaluate the safety and maximum tolerated dose of CLTX CAR T cell therapy of Chimeric in patients with recurrent or progressive GBM.
- Phase 1 study intends to enrol 18-36 patients with MMP2+ recurrent or progressive GBM across four dose levels.
- The study objectives are to assess the efficacy as well the safety of CLTX CAR T cells.
- It will also determine the recommended dose for the upcoming Phase 2 clinical trial.
On 23 April 2021, CHM shares were trading at AU$0.290 (at AEST 10:44 AM).