Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 1 study of Recurrent Osteosarcoma and Refractory Osteosarcoma, sponsored by Fred Hutchinson Cancer Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What NCT07227571 shows while recruiting
NCT07227571 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 64-participant average among 13 other Recurrent Osteosarcoma trials with a reported enrollment target (53% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Recurrent Osteosarcoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07227571's enrollment target sits among peer trials
30 10th of 13 higher than 3 of 13 other Recurrent Osteosarcoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Recurrent Osteosarcoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Study of Onivyde With Talazoparib or Temozolomide in Children With Recurrent Solid Tumors and Ewing Sarcoma
RECRUITING · Phase 1
-
Gemcitabine, Docetaxel, and Hydroxychloroquine in Treating Participants With Recurrent or Refractory Osteosarcoma
ACTIVE NOT RECRUITING · Phase 1
-
Pepinemab in Treating Younger Patients With Recurrent, Relapsed, or Refractory Solid Tumors
COMPLETED · Phase 1
-
Nivolumab With or Without Ipilimumab in Treating Younger Patients With Recurrent or Refractory Solid Tumors or Sarcomas
COMPLETED · Phase 1
-
Atezolizumab and Cabozantinib for the Treatment of Adolescents and Young Adults With Recurrent or Metastatic Osteosarcoma, TACOS Study
RECRUITING · Phase 2
-
Humanized Monoclonal Antibody 3F8 (Hu3F8) With Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in the Treatment of Recurrent Osteosarcoma
ACTIVE NOT RECRUITING · Phase 2
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00977977 · 30 participants · Phase 2
Rituximab Plus Cyclosporine in Idiopathic Membranous Nephropathy
- NCT01459107 · 30 participants · Phase 2
Human Upper Extremity Allotransplantation
- NCT01666080 · 30 participants · NA
Second or Greater Allogeneic Hematopoietic Stem Cell Transplant Using Reduced Intensity Conditioning (RIC)
- NCT01720836 · 30 participants · Phase 1
Study of the Immune Response of MUC1 (Mucin1) Peptide Vaccine for Non-small Cell Lung Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI