Allogeneic Stem Cell Transplant Depleting AlphaBeta T and CD19 B Cells Combined with Zoledronic Acid for Treating Relapsed or Refractory Solid Tumors in Children, Adolescents, and Young Adults

What this Trial Is About

Researchers are investigating a treatment for children, adolescents, and young adults with relapsed or refractory solid tumors. The study evaluates the safety and potential survival benefits of an allogeneic stem cell transplant depleted of alphabeta T cells and CD19 B cells combined with zoledronic acid. This approach aims to enhance the immune systems graft versus tumor effect and improve event-free and overall survival rates in these patients. Participants receive a stem cell transplant processed using the Miltenyi CliniMACS Prodigy system to remove specific immune cells. Zoledronic acid is given intravenously on days 28, 56, 84, 112, and 140 post-transplant. The study includes a phase Ib dose-finding portion to determine the maximum tolerated dose of zoledronic acid, followed by a phase II portion where all subjects receive this dose. During the trial, participants are closely monitored through various assessments including disease-free survival and incidence of acute graft-versus-host disease at multiple time points up to two years after transplant. The research team evaluates overall survival rates at 100 days, 1 year, and 2 years post-transplant. The study spans several years, with participants undergoing treatment and follow-up evaluations to track safety and effectiveness.

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