Alpha/Beta T and B Cell Depletion With Zoledronic Acid for Solid Tumors

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

November 30, 2025

Primary Completion Date

February 28, 2030

Study Completion Date

February 28, 2030

Conditions
NeuroblastomaRhabdomyosarcomaSynovial SarcomaPeripheral Nerve Sheath TumorsClear Cell SarcomaAlveolar Soft Part SarcomaDesmoplastic Small Round Cell TumorChordomaRhabdoid TumorEpithelioid SarcomaMyoepithelial TumorOsteosarcomaEwing Sarcoma
Interventions
DEVICE

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.

DRUG

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."

Trial Locations (1)

32610

RECRUITING

University of Florida, Gainesville

All Listed Sponsors
lead

University of Florida

OTHER

NCT06625190 - Alpha/Beta T and B Cell Depletion With Zoledronic Acid for Solid Tumors | Biotech Hunter | Biotech Hunter