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

Part of paid clinical trials in Seattle, Washington.

Sponsor
Fred Hutchinson Cancer Center
Study ID
NCT07227571
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Osteosarcoma
  • Recurrent Osteosarcoma
  • Refractory Osteosarcoma

Eligibility Criteria

Sex
ALL
Age
1 Year - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • FH FOLR1 ST CAR T-cells — BIOLOGICAL
    Given IV
  • Leukapheresis — PROCEDURE
    Undergo leukapheresis
  • Fludarabine — DRUG
    Given IV
  • Cyclophosphamide — DRUG
    Given IV
  • Echocardiography Test — PROCEDURE
    Undergo echocardiography
  • Multigated Acquisition Scan — PROCEDURE
    Undergo MUGA
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Positron Emission Tomography — PROCEDURE
    Undergo PET
  • Biopsy Procedure — PROCEDURE
    Undergo tumor biopsy

Study Details

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.

Key Dates

Start date
Jan 16, 2026
Status verified
Feb 2026
Primary completion
Jan 31, 2044
Completion
Jan 31, 2044

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (FH-FOLR1 ST CAR T cells)
    Patients undergo leukapheresis for manufacturing of the FH-FOLR1 ST CAR T cell product on study. Patients will receive lymphodepleting therapy with fludarabine IV on days -5 to -2 and cyclophosphamide IV on days -3 to -2. Patients receive FH-FOLR1 ST CAR T cells IV on day 0, 1 or 2 in the absence of unacceptable toxicity. Patients also undergo echocardiography or multigated acquisition scan (MUGA), blood sample collection, and CT, MRI or PET throughout the study. Additionally, patients may have the option of undergoing tumor biopsy on study.

Primary Outcome Measure

Incidence of treatment-related unexpected grade 3 or higher toxicity [ Time Frame: Up to 28 days post infusion ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutch/University of Washington/Seattle Children's Cancer ConsortiumSeattleWashington98109
Fred Hutch Immunotherapy Intake
[email protected]
206-606-4668
Seattle Children's Hospital Immunotherapy Intake
[email protected]
Michelle Choe, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Seattle, WA

By research site
Fred Hutch/University of Washington/Seattle Children's Cancer Consortium· Seattle, WA

Related Studies