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NCT07227571 · ClinicalTrials.gov registry record · Phase 1
Genetically Engineered Cells (FH-FOLR1 ST CAR T Cells) for the Treatment of Advanced Refractory or Recurrent/Progressive Osteosarcoma, FIERCe Trial
A Phase 1 study of Recurrent Osteosarcoma and Refractory Osteosarcoma, sponsored by Fred Hutchinson Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT07227571 is a Phase 1 study of Recurrent Osteosarcoma and Refractory Osteosarcoma that is actively recruiting participants, run by Fred Hutchinson Cancer Center. The registered enrollment target is 30 participants, below the 64-participant average among 13 other Recurrent Osteosarcoma trials with a reported enrollment target (53% lower). The trial reports 1 study location across 1 state.
The verdict
NCT07227571, a Phase 1 study of Recurrent Osteosarcoma and Refractory Osteosarcoma, is actively recruiting participants, sponsored by Fred Hutchinson Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- PROCEDURE Echocardiography Test
- PROCEDURE Leukapheresis
- BIOLOGICAL FH FOLR1 ST CAR T-cells
Study Locations (1)
Washington
- Fred Hutch/University of Washington/Seattle Children's Cancer Consortium - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2026-01-16 |
| Est. Completion | 2044-01-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07227571
The ClinicalTrials.gov registry entry for NCT07227571 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 64-participant average among 13 other Recurrent Osteosarcoma trials with a reported enrollment target (53% lower). The listed sponsor is Fred Hutchinson Cancer Center, which has 483 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Recurrent Osteosarcoma appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT07227571 reports 1 study location spanning 1 distinct geographic area - top geographies include Washington.
Frequently Asked Questions
What is clinical trial NCT07227571 about?
NCT07227571 is a clinical study titled "Genetically Engineered Cells (FH-FOLR1 ST CAR T Cells) for the Treatment of Advanced Refractory or Recurrent/Progressive Osteosarcoma, FIERCe Trial". 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 (advan...
What is the current status of trial NCT07227571?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2026-01-16. Estimated completion is 2044-01-31.
What conditions does trial NCT07227571 study?
This clinical trial studies the following conditions: Recurrent Osteosarcoma, Refractory Osteosarcoma, Advanced Osteosarcoma.
What interventions are being tested in trial NCT07227571?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Echocardiography Test (PROCEDURE), Leukapheresis (PROCEDURE), FH FOLR1 ST CAR T-cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT07227571?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07227571 being conducted?
This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.