Soheil Meshinchi, Professor of Translational Science and Therapeutics at Fred Hutch, shared on LinkedIn:
“An exciting milestone for AML immunotherapy: we have received FDA clearance to proceed with our CLEC2A-directed CAR T-cell clinical trial which will be enrolling adult and pediatric patients at Fred Hutch Cancer Center, Seattle Children’s Hospital and Children’s Hospital of LA. CLEC2A is the second of three AML-restricted CAR T-cell therapies we are bringing into clinical implementation. Our FOLR1 CAR T-cell trial is advancing into phase II trial after safely treating eight patients with significant efficacy. Our mesothelin CAR T-cell trial is anticipated to activate in early 2027.
Together, these programs advance our goal of effectively targeting AML-restricted antigens while preserving normal hematopoiesis. This first-in-human CLEC2A study will mark the first clinical effort to target this novel antigen, identified through our TpAML-supported proteo-genomic discovery program.
Our initial focus is KMT2A-rearranged and monosomy 7 AML – subsets with a pressing need for more effective therapies. As an AML-restricted target, that is silent in normal hematopoiesis, CLEC2A offers the potential to eradicate leukemia without hematopoietic toxicity. The trial will test whether the potent antileukemic activity observed in our preclinical models translates into effective therapy without on-target hematopoietic toxicity.
A special acknowledgment goes to Danielle Kirkey, the engineer behind this effort and principal investigator of the clinical study. Her scientific leadership and dedication have been instrumental in bringing this therapy from discovery to clinical readiness. In 4 years! We also thank Dr. Wei Li at the University of Pittsburgh for developing the fully human antibody that forms the foundation of our CLEC2A CAR.
Our collaboration with Professor Franco Locatelli and his team at Ospedale Pediatrico Bambino Gesù (OPBG) in Rome is central to this work. Together, we are advancing all three AML-restricted CAR T-cell programs along parallel clinical development paths at Fred Hutch and OPBG, supporting trial activation in the United States and Europe.
For CLEC2A, the Rome team is advancing a retroviral construct using the same antibody binder, with anticipated trial activation in early 2027. Joint protocol development and shared scientific expertise connect these efforts across both centers. We are grateful to our collaborators and the TpAML community whose support has helped turn target discovery into new therapeutic possibilities for patients with AML.”
Mazyar Shadman, Medical Director of Cellular Immunotherapy at Fred Hutch Cancer Center, added:
“Exciting news. Strong homegrown AML Immunotherapy CART portfolio at Fred Hutch.
Congratulations to Dr. Soheil Meshinchi and colleagues and look forward to delivering these novel treatments to our patients at Fred Hutch Bezos Family Immunotherapy Clinic.”
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