155
Participants
Start Date
October 28, 2025
Primary Completion Date
November 1, 2030
Study Completion Date
October 1, 2034
mCD19-CAR-CD28-CD3-zeta.(anti-CD19 CAR) retroviral vector-transduced allogeneic peripheral blood lymphocytes (PBL)
CAR-T cell infusion given at four escalating dose levels (DL1: 3 x 10\^4 cells/kg, DL2: 1 x 10\^5 cells/kg, DL3: 3 x 10\^5 cells/kg, DL4: 1 x 10\^6 cells/kg) with a dose de-escalation dose (DL-1: 1 x 10\^4 cells/kg), if needed.
Fludarabine
Pre-transplant: 30 mg/m\^2 IV infusion over 30-60 minutes once daily for 5 days from day -6 through day -2
Cyclophosphamide
"Pre-transplant: 14.5 mg/kg/day IV daily for 2 days pre-transplant on day -6 and day -5.~Post-transplant: 25 mg/kg/day on day +3 and day +4."
Mycophenolate Mofetil
15 mg/kg orally or IV three times daily (max 1000 mg/dose) starting on day +5, continued through day +35 post-transplant.
Sirolimus
Loading dose of 6 mg orally given on day +5, then maintenance dose starting at 2 mg orally daily on day +6 with dose adjustments to maintain a trough of 5-12 ng/ml, continued through day +60 post-transplant.
CD19 Flow Cytometry Assay
Assay used to determine CD19+ status
CD19 Immunohistochemical Assay
Assay used to determine CD19+ status
Total Body Irradiation
400 centigray (cGy) to be delivered in 2 fractions as 200 cGy per fraction twice a day on Day -1 pre-transplant.
National Institutes of Health Clinical Center, Bethesda
National Cancer Institute (NCI)
NIH