27
Participants
Start Date
November 30, 2025
Primary Completion Date
February 28, 2030
Study Completion Date
February 28, 2030
Miltenyi CliniMACS Prodigy ® system
Subjects will receive an allogeneic stem cell transplant that has been depleted of ⍺/β T-cells and CD19+ B-cells using the Miltenyi CliniMACS Prodigy® system.
Zoledronic acid
"All subjects will receive zoledronic acid intravenously on days +28, +56, +84, +112, and +140.~Dosing in the phase Ib portion of the study will follow a 3 + 3 design where the first 3 subjects will receive the expected phase II dose of 1.25 mg/m2 (dose level 1). If no dose-limiting toxicities (DLTs) occur in these subjects, dose level 1 will be the maximum tolerated dose. However, if at least 1 DLT is observed in the first 3 patients, 3 additional subjects will be enrolled at dose level 1. If more than 2 DLTs are observed in these 6 subjects, then dose de-escalation to 0.8 mg/m2 (dose level 0) will occur and 3-6 additional subjects may be enrolled.~All subjects in the phase II portion of the study will receive the maximum tolerated dose determined in the phase Ib portion."
RECRUITING
University of Florida, Gainesville
University of Florida
OTHER