Australian cell therapy specialist Chimeric Therapeutics (ASX:CHM) has executed a clinical study agreement with The University of Texas MD Anderson Cancer Centre to support the “ADVENT-AML” Phase 1B study.
The study will evaluate Chimeric’s off-the-shelf universal donor NK cell therapy CHM 0201 in combination with standard of care therapy for patients with newly diagnosed Acute Myeloid Leukemia (AML).
The ADVENT-AML study is designed to enroll up to 20 subjects with newly diagnosed AML who are not eligible for intensive chemotherapy or allogeneic stem cell transplant, following completion of a dose confirmation cohort assessing the safety of this novel combination treatment in subjects with relapsed or refractory AML.
ADVENT-AML will be the first trial to evaluate the synergy of NK cell therapy in combination with the current standard of care of Azacitidine with Venetoclax (AZA-VEN). As the trial progresses beyond dose confirmation, it will also be the first trial to evaluate cellular therapy in newly diagnosed AML patients.
The study, which has received IND clearance by the FDA and is expected to open to enrollment at MD Anderson by year end 2023, will be led by Principal Investigator Abhishek Maiti MD, Assistant Professor in the Department of Leukemia at MD Anderson.
Acute Myeloid Leukemia (AML) is the most common acute leukemia in adults with a median age at diagnosis between 65-72 years. Despite treatment advances, patients who are not eligible for intensive chemotherapy or allogeneic stem cell transplant patients have limited therapeutic options. Outcomes for these high-risk subgroups are poor with median overall survival (mOS) of 6 to 9 months in the newly diagnosed setting and 2.4 months for patients with relapse or refractory disease. Consequently, novel therapies are urgently needed to improve outcomes for patients with AML.
“This exciting new clinical trial aligns with the emerging evidence that cell therapies provide the best clinical outcomes in the earliest line of treatment,” said Jason B Litten, MD, Chief Medical Officer of Chimeric Therapeutics.
“By combining CHM 0201 with the current standard of care for AML patients we may be able to significantly enhance the outcomes for these patients.”
Under the terms of the clinical study agreement, Chimeric will provide CHM 0201 study drug as well as partial financial support for study. In addition to the modest financial support from Chimeric, the study will be supported by grant funding from multiple funding sources including Gateway for Cancer Research.
