Australian cell therapy company Chimeric Therapeutics (ASX:CHM) has announced that the Phase 1B ADVENT-AML trial of CHM CORE-NK has advanced to the next planned cohort.
The ADVENT-AML (NCT05834244) Phase 1B clinical trial is an investigator-initiated trial currently open to enrollment at The University of Texas MD Anderson Cancer Center under principal investigator Dr Abhishek Maiti.
Chimeric said this is the first trial to evaluate the synergy of NK cell therapy in combination with the current standard of care for acute myeloid leukemia (AML), Azacitidine and Venetoclax.
In the first cohort, which opened to enrolment in the first quarter of 2024, three subjects with relapsed or refractory AML received CHM CORE-NK at dose level one, combined with standard-of-care Azacitidine and Venetoclax. No dose-limiting toxicities were reported during the 28-day DLT evaluation period.
Following a review of the data from the first three patients, the safety monitoring committee has authorised the trial to advance to the next cohort, in which three subjects with relapsed or refractory AML will receive CHM CORE-NK at Dose Level 2 in combination with Azacitidine and Venetoclax. The study is designed to then enrol up to 20 subjects with newly diagnosed AML who are not eligible for intensive chemotherapy or allogeneic stem cell transplant.
“It has been great to see the progress of this clinical trial for these AML patients,” said Dr Rebecca McQualter, chief operating officer of Chimeric.
