OncoMatch/Clinical Trials/NCT07227571
Genetically Engineered Cells (FH-FOLR1 ST CAR T Cells) for the Treatment of Advanced Refractory or Recurrent/Progressive Osteosarcoma, FIERCe Trial
Is NCT07227571 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments including FH FOLR1 ST CAR T-cells and Fludarabine for advanced osteosarcoma.
Treatment: FH FOLR1 ST CAR T-cells · Fludarabine · Cyclophosphamide — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Osteosarcoma
Performance status
ECOG OR LANSKY/KARNOFSKY 0–2
ECOG performance status of 0-2 (if treated at adult facility) or Lansky/Karnofsky score ≥ 60 (if treated at pediatric facility). Participants who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for purposes of assessing performance status
Prior therapy
Must have received: anthracycline
Must have received an anthracycline-based regimen or been deemed ineligible to receive this therapy
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 500 cells/mm^3; Hemoglobin ≥ 8 g/dL; Platelets ≥ 100,000 per mm^3. Participants receiving blood product transfusion are acceptable as long as they are not determined to be transfusion refractory.
Kidney function
Serum creatinine ≤ 1.5 x ULN based on age and gender; or estimated creatinine clearance > 50 mL/min as calculated using the Cockcroft-Gault formula and not dialysis dependent. Age-specific creatinine cutoffs provided.
Liver function
Total bilirubin ≤ 3 x ULN or conjugated bilirubin ≤ 2 mg/dL. Participants with suspected Gilbert syndrome may be included if total bilirubin (Bili) > 3 mg/dL but no other evidence of hepatic dysfunction. AST and ALT < 5 x ULN.
Cardiac function
Left ventricular ejection fraction (LVEF) ≥ 50% or shortening fraction ≥ 28% by echocardiogram or MUGA scan.
Serum creatinine ≤ 1.5 x upper limit of normal (ULN) based on age and gender; or estimated creatinine clearance > 50 mL/min as calculated using the Cockcroft-Gault formula and not dialysis dependent. Total bilirubin ≤ 3 x ULN or conjugated bilirubin ≤ 2 mg/dL. AST and ALT < 5 x ULN. Pulmonary: ≤ grade 1 dyspnea at rest and arterial oxygen saturation (SaO2) ≥ 92% on ambient air. If pulmonary function tests (PFTs) are performed based on the clinical judgement of the treating physician, participants with forced expiratory volume in 1 second (FEVI) ≥ 50% of predicted and diffusion capacity of the lung for carbon monoxide (DLCO) (corrected) of ≥ 40% of predicted will be eligible. Left ventricular ejection fraction (LVEF) may be established with echocardiogram or MUGA scan, and left ejection fraction must be ≥ 50% or shortening fraction ≥ 28%. Absolute neutrophil count (ANC) ≥ 500 cells/ mm^3. Hemoglobin ≥ 8 g/dL. Platelets ≥ 100,000 per mm^3. Participants receiving blood product transfusion are acceptable as long as they are not determined to be transfusion refractory.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Fred Hutch/University of Washington/Seattle Children's Cancer Consortium · Seattle, Washington
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