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Highlights
- Chimeric completes the final dose escalation cohort in the CHM 1101 Phase 1A brain cancer clinical trial.
- The safety and efficacy of the trial will be examined before the end of this year.
- Phase 1B trial has commenced and is currently open for enrolment.
Chimeric Therapeutics (ASX: CHM) has completed the fourth and final dose escalation cohort in the CHM 1101 (CLTX CAR T) Phase 1A clinical trial after treating the third participant in the trial.
The company is expected to share the update on efficacy and safety from the trial before the end of this year.
Details about the clinical trial
CHM has licensed the exclusive global rights to intellectual property covering the chlorotoxin CAR-T cells from City of Hope, a cancer treatment and research firm in the United States.
The trial’s principal investigator is Behnam Badie, M.D., Chief of Division of Neurosurgery at the City of Hope.
The clinical trial has been undertaken at the Los Angeles campus of City of Hope.
The study objective is to examine the efficacy and safety of CLTX CAR T and to ascertain the recommended dosing for a Phase 2 trial.
Participants with MMP2+ recurrent or progressive glioblastoma (GBM) were enrolled across four dose levels as a part of the trial. At this dose level, the participants received 440 x 106 CHM 1101 cells by dual intraventricular and intratumoral administration routes.
Phase 1B clinical trial is open for enrolment
The company has now begun with the development of CHM 1101 to a Phase 1B trial, which is open for enrolment at the Sarah Cannon Transplant & Cellular Therapy Program at St. David’s South Austin Medical Center in Austin, Texas.
This trial is a two-part clinical trial which intends to ascertain the suggested Phase 2 dose and administration schedule. Under Phase A of the trial, 3-6 participants will be enrolled at the maximum dose tested in the Phase 1A clinical trial.
If the company receives a favourable review of the CHM 1101 clinical trial, then the Part B dose expansion cohort will be opened, and 12-26 participants will be enrolled.
After completion of the Part B dose expansion cohort, CHM plans to design and commence a registration trial in line with the feedback and regulatory guidance.
CHM shares jump over 11%
Triggered by the update, CHM shares jumped 11.43% to trade at AU$0.039 apiece at the time of writing on 29 August 2023.
