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- Chimeric Therapeutics (CHM) treats the third participant in its phase 1A dose escalation study using CHM 1101, bringing the fourth and final cohort to a close
- The trial used a maximum dose of 440 X 10 CHM 1101 CAR T cells to evaluate the safety and maximum dose in patients with recurrent or progressive glioblastoma
- Meanwhile, a phase 1B trial is ongoing at the Sarah Cannon Transplant ND Cellular Therapy Program at Saint David’s South Austin Medical Center
- Both trials will determine a recommended phase two dose and administration schedule to initiate a registration clinical trial
- CHM shares are up 14.3 per cent, trading at 4 cents at 2:54 pm AEST
Chimeric Therapeutics (CHM) has treated the third patient participating in its phase 1A dose escalation study at the City of Hope Hospital in California.
This clinical trial involves the company’s novel drug candidate, CHM 1101, and marks the completion of the fourth and final cohort.
The study focused on assessing safety and determining the maximum tolerated dose in patients with recurrent or progressive glioblastoma (GBM).
In this final dose cohort, patients received CHM 1101 cells at a total dose 440 X 10 CHM 1101 CAR T cells administered through dual routes: intratumoral and intraventricular.
Simultaneously, a phase 1B trial is ongoing at the Sarah Cannon Transplant and Cellular Therapy Program at Saint David’s South Austin Medical Center. Both trials aim to establish a recommended phase two dose and administration schedule.
“We are very pleased that the phase 1A City of Hope clinical trial has completed dose escalation at all four planned dose levels,” CHM CEO and Managing Director Jennifer Chow said.
“We look forward to providing an update on the safety and efficacy of the trial before the end of the year.”
Chimeric Therapeutics has obtained exclusive global rights to its intellectual property related to chlorotoxin CAR-T cells from the City of Hope, a prominent cancer research and treatment organization in the United States.
The phase 1B trial consists of two parts, with the first part enrolling between three and six patients at the highest dose tested during the phase 1A clinical trial at the City of Hope.
Based on a favourable review of the results from this assessment, the second part of the trial, a dose expansion cohort, will enrol an additional 12 to 26 participants.
Upon successful completion of the second part of the dose expansion cohort, the company intends to design and initiate a registrational trial in accordance with regulatory guidance and feedback.
CHM shares were up 14.3 per cent, trading at 4 cents at 2:54 pm AEST.
