Actively Recruiting
Genetically Engineered Cells (FH-FOLR1 ST CAR T Cells) for the Treatment of Advanced Refractory or Recurrent/Progressive Osteosarcoma, FIERCe Trial
Led by Fred Hutchinson Cancer Center · Updated on 2026-02-11
30
Participants Needed
1
Research Sites
941 weeks
Total Duration
On this page
Sponsors
F
Fred Hutchinson Cancer Center
Lead Sponsor
W
Washington Research Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Genetically Engineered Cells (FH-FOLR1 ST CAR T Cells) for the Treatment of Advanced Refractory or Recurrent/Progressive Osteosarcoma, FIERCe Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 1 to 75 years at enrollment
- Confirmed diagnosis of osteosarcoma by tissue testing
- Received anthracycline-based chemotherapy or deemed ineligible for it
- Evidence of new or progressive measurable or evaluable disease within 6 months before consent
- Discontinuation of all anti-cancer therapies with required washout periods before enrollment
- Recovery to grade 1 from adverse events of prior therapy before enrollment
- Ability to understand and sign informed consent
- Willingness to use effective contraception during and 12 months after CAR T cell infusion if of child-bearing potential or fertile male
- ECOG performance status 0-2 (adult) or Lansky/Karnofsky score ≥ 60 (pediatric)
- Life expectancy of at least 8 weeks
- Able to tolerate leukapheresis or has apheresis product available
- Prior or concurrent malignancies allowed if they do not interfere with study assessments
- Treated brain metastases allowed if stable for 3 months and no ongoing symptomatic CNS issues
- Kidney function within specified limits based on age and gender
- Total bilirubin ≤ 3 x ULN or conjugated bilirubin ≤ 2 mg/dL; Gilbert syndrome cases considered
- AST and ALT less than 5 x ULN
- Pulmonary function with ≤ grade 1 dyspnea and oxygen saturation ≥ 92% on room air
- Left ventricular ejection fraction ≥ 50% or shortening fraction ≥ 28%
- Absolute neutrophil count ≥ 500 cells/mm³
- Hemoglobin ≥ 8 g/dL
- Platelets ≥ 100,000 per mm³
- Acceptable blood transfusions if not transfusion refractory
You will not qualify if you...
- Active autoimmune disease needing immunosuppressive therapy (case-by-case exceptions)
- Corticosteroid therapy exceeding prednisone 15 mg/day or equivalent, except pulsed use for disease control
- Concurrent use of other investigational anti-cancer agents
- Active uncontrolled infections (controlled HIV, hepatitis B/C allowed if well managed)
- Uncontrolled illnesses such as symptomatic heart failure, unstable angina, or arrhythmias
- Ongoing treatment for serious immune-related adverse events from prior immunotherapy
- Significant active neurologic diseases unless approved by investigator
- Pregnancy or potential to conceive/father children during study and 4 months after T cell infusion
- Unwillingness to provide consent for participation and 15-year follow-up if treated
- Any medical, social, or psychiatric condition interfering with study participation
- Known allergies to study treatment components
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fred Hutch/University of Washington/Seattle Children's Cancer Consortium
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
F
Fred Hutch Immunotherapy Intake
CONTACT
S
Seattle Children's Hospital Immunotherapy Intake
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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