Soheil Meshinchi, Professor of Translational Science and Therapeutics at Fred Hutch, shared a post on LinkedIn:
“After the successful delivery of first in human FOLR1-CART to infants with CBF/GLIS AML, we are excited to announce that the Fred Hutch FOLR1-CART has now received FDA clearance to proceed for treatment of relapsed/refractory osteosarcoma. Activation for accrual is expected in early January 2026.
This trial is based on the observation that FOLR1 is highly expressed in osteosarcoma, and preclinical studies from our lab demonstrated strong efficacy of the FHCC FOLR1-CART in osteosarcoma in vitro and in vivo models (PMID: 40919994). The safety and efficacy data from the first three patients treated with this CART for CBF/GLIS AML facilitated the rapid FDA clearance of this product in osteosarcoma.
The study will be open to patients ages 1–75 years. Dr. Michelle Choe and Dr. Lawrence Fong from FHCC will serve as the clinical leads for the trial (ClinicalTrials.gov ID: NCT07227571). We anticipate expansion of the trial to include other FOLR1 positive malignancies in children and adults in the next year.”
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