FH-FOLR1 Chimeric Antigen Receptor T Cell Therapy for Treating Pediatric Patients With Relapsed or Refractory Acute Myeloid Leukemia

Part of paid clinical trials in Seattle, Washington.

Sponsor
Fred Hutchinson Cancer Center
Study ID
NCT06609928
Phase
PHASE1
Status
Recruiting
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Conditions

  • Recurrent Childhood Acute Myeloid Leukemia
  • Refractory Childhood Acute Myeloid Leukemia

Eligibility Criteria

Sex
ALL
Age
N/A - 6 Years
Healthy Volunteers
Not accepted

Interventions

  • FOLR1 CAR T-cells — BIOLOGICAL
    Given IV
  • Biospecimen Collection — PROCEDURE
    Undergo CSF and blood sample collection
  • Bone Marrow Aspiration — PROCEDURE
    Undergo bone marrow aspiration
  • Bone Marrow Biopsy — PROCEDURE
    Undergo bone marrow biopsy
  • Cyclophosphamide — DRUG
    Given IV
  • Echocardiography Test — PROCEDURE
    Undergo ECHO
  • Fludarabine — DRUG
    Given IV
  • Pheresis — PROCEDURE
    Undergo apheresis
  • Positron Emission Tomography — PROCEDURE
    Undergo PET

Study Details

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.

Key Dates

Start date
Feb 24, 2025
Status verified
Jan 2026
Primary completion
Oct 1, 2027
Completion
Oct 1, 2042

Study Design

Enrollment
12 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (FH-FOLR1 CAR T)
    Patients undergo apheresis to obtain T cells for product manufacturing. Patients receive lymphodepleting chemotherapy with fludarabine IV on days -4 to -1 and cyclophosphamide IV on days -4 and -3. Patients receive FH-FOLR1 CAR T IV on day 0. Patients undergo ECHO at screening, undergo collection of CSF and blood samples and bone marrow aspiration/biopsy throughout the study, and may undergo PET scan on study and during follow up.

Primary Outcome Measure

Incidence of adverse events [ Time Frame: Up to 15 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutch/University of Washington/Seattle Children's Cancer ConsortiumSeattleWashington98109
Katherine G. Tarlock, MD
[email protected]
206-667-7121
Katherine G. Tarlock, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Fred Hutch/University of Washington/Seattle Children's Cancer Consortium· Seattle, WA

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