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Study identifier: NCT07227571 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Genetically Engineered Cells (FH-FOLR1 ST CAR T Cells) for the Treatment of Advanced Refractory or Recurrent/Progressive Osteosarcoma, FIERCe Trial

Condition: Advanced Osteosarcoma · Recurrent Osteosarcoma · Refractory Osteosarcoma  ·  Sponsor: Fred Hutchinson Cancer Center

PhasePhase 1
Planned participants30
Who can joinAll sexes, 1 Year to 75 Years
Healthy volunteersNo

About this study

This phase I trial tests the safety, side effects, and best dose of FH-FOLR1 ST chimeric antigen receptor (CAR) T cells and how well they work in treating patients with osteosarcoma that recurred or spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) and that has not responded to previous treatment (refractory) or has come back after a period of improvement (recurrent)/is growing, spreading, or getting worse (progressive). CAR T-cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they attack tumor cells. T cells are taken from a patient's blood through a process called apheresis. Then the gene for a special receptor that binds to a certain protein on the patient's tumor cells, such as FOLR1, is added to the T cells in the laboratory. The special receptor is called a CAR. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by an intravenous infusion. Chemotherapy drugs, such as fludarabine and cyclophosphamide, are given to a patient before the manufactured FH-FOLR1 ST CAR T cells to make room for the CAR T cells in the blood and to enhance the CAR T cell activity in the patient. FH-FOLR1 ST CAR T cells may be safe, tolerable, and/or effective in treating patients with advanced refractory or recurrent/progressive osteosarcoma.

This description comes directly from the study's public registry record.

Talk to the study team

Fred Hutch Immunotherapy Intake  ·  206-606-4668  ·  immunotherapy@fredhutch.org

Seattle Children's Hospital Immunotherapy Intake  ·  immunotherapy@seattlechildrens.org

Always discuss trial participation with your own doctor first.

Locations (1)

Fred Hutch/University of Washington/Seattle Children's Cancer ConsortiumSeattle, Washington, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT07227571