Actively Recruiting
Genetically Engineered FH-FOLR1 ST CAR T Cells for Treating 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
N/A
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
Researchers are evaluating the safety, side effects, and best dose of FH-FOLR1 ST chimeric antigen receptor (CAR) T cells in treating patients with advanced osteosarcoma that has returned, spread, or not responded to previous treatments. This phase I trial focuses on patients with refractory, recurrent, or progressive osteosarcoma to study how these genetically modified immune cells work against tumor cells. CAR T-cell therapy involves modifying a patient's T cells to target a specific protein on tumor cells called FOLR1. Participants undergo leukapheresis to collect T cells for manufacturing the FH-FOLR1 ST CAR T cell product. Before receiving CAR T cells, patients get lymphodepleting chemotherapy with fludarabine and cyclophosphamide intravenously over several days. The CAR T cells are then infused intravenously on day 0, 1, or 2 if no serious toxicity occurs. Throughout the study, patients may undergo echocardiography or MUGA scans, blood sample collections, and imaging tests like CT, MRI, or PET. Tumor biopsies are optional. After the CAR T cell infusion, patients are closely monitored for at least 28 days. Follow-up visits occur frequently in the first weeks and months, then every six months for three years, followed by annual visits for up to ten years. Those with ongoing CAR T cell persistence have additional follow-ups. Researchers assess treatment-related toxicities, maximum tolerated dose, disease progression, survival, response rates, and clinical benefits during the study.
CONDITIONS
Brief 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 regimen or deemed ineligible for it
- Evidence of new or measurable disease progression within 6 months prior to consent
- Discontinued all anti-cancer therapy with specified washout periods before enrollment
- Recovered to grade 1 from previous treatment side effects
- Willing and able to sign informed consent
- Females of child-bearing potential and fertile males must use effective contraception before, during, and 12 months after treatment
- ECOG performance status 0-2 or Lansky/Karnofsky score ≥ 60
- Life expectancy of at least 8 weeks
- Able to tolerate apheresis or have an available apheresis product
- Prior or concurrent malignancies allowed if not interfering with study
- Treated brain metastases allowed if stable and no ongoing symptoms
- Kidney function within specified limits based on age and gender
- Liver function within specified limits
- Pulmonary function with minimal symptoms and adequate oxygen saturation
- Left ventricular ejection fraction ≥ 50% or shortening fraction ≥ 28%
- Adequate blood counts (neutrophils, hemoglobin, platelets)
- Blood transfusions allowed if not refractory
You will not qualify if you...
- Active autoimmune disease requiring immunosuppressive therapy (case-by-case exceptions possible)
- Corticosteroid use above specified dosage limits (some exceptions allowed)
- Concurrent use of other investigational anti-cancer agents
- Active uncontrolled infections, except controlled HIV, hepatitis B or C
- Uncontrolled or serious concurrent illnesses limiting study compliance
- Ongoing treatment for prior serious immune-related adverse events, except certain hormone or steroid therapies
- Significant active neurologic diseases, except certain neuropathies
- Pregnant, possibly pregnant, or planning conception during the trial and 4 months after infusion
- Unwilling to provide consent or assent for the study and 15-year follow-up
- Other medical, social, or psychiatric conditions 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 5 days
Participants undergo leukapheresis to collect cells for manufacturing the FH-FOLR1 ST CAR T cell product and receive lymphodepleting therapy with fludarabine and cyclophosphamide before treatment.
Multiple visits during days -5 to -2 for fludarabine and days -3 to -2 for cyclophosphamide
Duration - Single day treatment on day 0, 1, or 2
Participants receive FH-FOLR1 ST CAR T cells intravenously on day 0, 1, or 2 if no unacceptable toxicity occurs.
1 visit (in-person) for CAR T cell infusion
Duration - At least 28 days post infusion
Participants are closely monitored for safety and response including echocardiography or MUGA scans, blood sample collection, and imaging (CT, MRI, or PET). Tumor biopsy may also be performed optionally.
Frequent visits during the first 28 days after infusion
Duration - Up to 10 years
Participants have follow-up visits to assess safety and treatment persistence with periodic assessments including imaging and blood tests for up to 10 years.
Visits on days 1, 7, 14, 21, 28, and 42; months 2, 3, 6, 12, and 24; then every 6 months for 3 years followed by annually for 10 years. Additional visits for those with ongoing CAR T cell persistence.
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
S
Seattle Children's Hospital Immunotherapy Intake
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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