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

Summary

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

• Advanced Osteosarcoma
• Recurrent Osteosarcoma
• Refractory Osteosarcoma

Interventions

BIOLOGICAL

FH FOLR1 ST CAR T-cells

Given IV

PROCEDURE

Leukapheresis

Undergo leukapheresis

DRUG

Fludarabine

Given IV

DRUG

Cyclophosphamide

Given IV

PROCEDURE

Echocardiography Test

Undergo echocardiography

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Computed Tomography

Undergo CT

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

PROCEDURE

Positron Emission Tomography

Undergo PET

PROCEDURE

Biopsy Procedure

Undergo tumor biopsy

Sponsors & Collaborators

• Washington Research Foundation

  collaborator UNKNOWN

• Fred Hutchinson Cancer Center

  lead OTHER

Principal Investigators

• Michelle Choe, MD · Fred Hutch/University of Washington/Seattle Children's Cancer Consortium

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

1 Year

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-16

Primary Completion

2044-01-31

Completion

2044-01-31

FDA Drug

Yes

Countries

• United States

Study Locations