Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06609928
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
FH-FOLR1 Chimeric Antigen Receptor T Cell Therapy for Treating Pediatric Patients With Relapsed or Refractory Acute Myeloid Leukemia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1 Study of FOLR1 CAR T for Pediatric Patients With Relapsed or Refractory AML
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 patients 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 patients blood Then the gene for a special receptor that binds to a FOLR1 on the patients 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
Detailed Description:
OUTLINE This is a dose-escalation study of FH-FOLR1 CAR T
Patients undergo apheresis to obtain T cells for product manufacturing receive lymphodepleting chemotherapy with fludarabine intravenously IV on days -4 to -1 cyclophosphamide IV on days -4 and -3 and receive FH-FOLR1 CAR T IV on day 0 Patients undergo echocardiography ECHO at screening undergo collection of cerebrospinal fluid CSF blood samples and bone marrow aspirationbiopsy throughout the study and may undergo imaging such as positron emission tomography PET scan
After completion of study treatment patients are followed up for 15 years
Patients undergo apheresis to obtain T cells for product manufacturing receive lymphodepleting chemotherapy with fludarabine intravenously IV on days -4 to -1 cyclophosphamide IV on days -4 and -3 and receive FH-FOLR1 CAR T IV on day 0 Patients undergo echocardiography ECHO at screening undergo collection of cerebrospinal fluid CSF blood samples and bone marrow aspirationbiopsy throughout the study and may undergo imaging such as positron emission tomography PET scan
After completion of study treatment patients are followed up for 15 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None