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 (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 ce

Trial Details

NCT ID
NCT06609928
Phase
PHASE1
Sponsor
Fred Hutchinson Cancer Center
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • FOLR1 CAR T-cells
  • Biospecimen Collection
  • Bone Marrow Aspiration
  • Bone Marrow Biopsy
  • Cyclophosphamide
  • Echocardiography Test
Locations (sample)
  • Seattle, Washington, United States|47.60621,-122.33207

Key Eligibility Criteria

  • Subject age ≤ 6 years.
  • Weight ≥ 7 kilograms.
  • AML that expresses FOLR1 by flow cytometry as assessed by Hematologics, Inc.
  • Laboratory and meets one of the below definitions:

For full eligibility, visit ClinicalTrials.gov.

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