54
Participants
Start Date
March 26, 2018
Primary Completion Date
July 10, 2024
Study Completion Date
January 13, 2025
CD19/CD22 CAR T-Cells
Cluster of differentiation 19 (CD19)/cluster of differentiation 22 (CD22) chimeric antigen receptor (CAR) T-cells will be infused on Day 0 after lymphodepleting chemotherapy regimen.
Fludarabine
Fludarabine is administered as an intravenous (IV) infusion in an appropriate solution over 30 minutes. To prevent undue toxicity the dose will be based on body surface area (BSA) (25-30 mg/m\^2/dose) on Days -4, -3, -2 or Days -5, -4, -3, -2.
Cyclophosphamide
Cyclophosphamide will be diluted in an appropriate solution and infused over one hour. The dose will be based on the body surface area (BSA), at 900 mg/m\^2/dose after fludarabine infusion on Day -2 or 600 mg/m\^2/dose on Days -3 \& -2.
Apheresis
According to institutional standards.
Anti-emetic
Prophylaxis and treatment.
Diphenhydramine
Pre-medication: 0.5-1 mg/kg/dose (maximum 50 mg/dose) by mouth or intravenous over 10-15 minutes.
Acetaminophen
Pre-medication: 15 mg/kg/dose (maximum 650 mg/dose by mouth).
ECG
Pre-cell infusion.
ECHO
Pre-cell infusion.
MRI Brain
Pre-cell infusion.
Bone marrow biopsy
Pre-cell infusion.
Cardiac MRI
Screening
National Institutes of Health Clinical Center, Bethesda
National Cancer Institute (NCI)
NIH