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NCT06609928 · ClinicalTrials.gov registry record · Phase 1
FH-FOLR1 Chimeric Antigen Receptor T Cell Therapy for Treating Pediatric Patients With Relapsed or Refractory Acute Myeloid Leukemia
A Phase 1 study of Recurrent Childhood Acute Myeloid Leukemia and Refractory Childhood Acute Myeloid Leukemia, sponsored by Fred Hutchinson Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT06609928 is a Phase 1 study of Recurrent Childhood Acute Myeloid Leukemia and Refractory Childhood Acute Myeloid Leukemia that is actively recruiting participants, run by Fred Hutchinson Cancer Center. The registered enrollment target is 12 participants, below the 57-participant average among 6 other Recurrent Childhood Acute Myeloid Leukemia trials with a reported enrollment target (79% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06609928, a Phase 1 study of Recurrent Childhood Acute Myeloid Leukemia and Refractory Childhood Acute Myeloid Leukemia, is actively recruiting participants, sponsored by Fred Hutchinson Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I trial tests the safety, side effects, and best dose of FH-FOLR1 chimeric antigen receptor (CAR) T cells in treating pediatric patients with FOLR1+ acute myeloid leukemia (AML) that has come back after a period of improvement (recurrent) or has not responded to previous treatment (refractory). 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 will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a FOLR1 on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Chemotherapy drugs, such as fludarabine and cyclophosphamide, are given to a patient before the manufactured FH-FOLR1 CAR T cells are infused back into the patient to assist in the CAR T cell activity in the patient. The trial is evaluating if giving FH-FOLR1 CAR T cell therapy is safe and tolerable for pediatric patients with recurrent or refractory AML.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Marrow Aspiration
- PROCEDURE Bone Marrow Biopsy
- BIOLOGICAL FOLR1 CAR T-cells
Study Locations (1)
Washington
- Fred Hutch/University of Washington/Seattle Children's Cancer Consortium - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2025-02-24 |
| Est. Completion | 2042-10-01 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06609928
The ClinicalTrials.gov registry entry for NCT06609928 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 57-participant average among 6 other Recurrent Childhood Acute Myeloid Leukemia trials with a reported enrollment target (79% lower). The listed sponsor is Fred Hutchinson Cancer Center, which has 483 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Recurrent Childhood Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT06609928 reports 1 study location spanning 1 distinct geographic area - top geographies include Washington.
Frequently Asked Questions
What is clinical trial NCT06609928 about?
NCT06609928 is a clinical study titled "FH-FOLR1 Chimeric Antigen Receptor T Cell Therapy for Treating Pediatric Patients With Relapsed or Refractory Acute Myeloid Leukemia". This phase I trial tests the safety, side effects, and best dose of FH-FOLR1 chimeric antigen receptor (CAR) T cells in treating pediatric patients with FOLR1+ acute myeloid leukemia (AML) that has come back after a period of improvement (recurrent) or has not responded to previous treatment (refrac...
What is the current status of trial NCT06609928?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2025-02-24. Estimated completion is 2042-10-01.
What conditions does trial NCT06609928 study?
This clinical trial studies the following conditions: Recurrent Childhood Acute Myeloid Leukemia, Refractory Childhood Acute Myeloid Leukemia.
What interventions are being tested in trial NCT06609928?
The interventions under investigation include: Cyclophosphamide (DRUG), Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), FOLR1 CAR T-cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT06609928?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06609928 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.