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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age6-25
SponsorUniversity of Florida

About this trial

Hematopoietic stem cell transplantation can cure patients with blood cancer and other underlying diseases. αβ-T cell and B cell depletion has been introduced to decrease GVHD and PTLD and has demonstrated effectiveness for hematologic malignancies and non-malignant diseases additionally increasing the donor pool as to allow for haploidentical transplant to safely occur.

While solid tumors can be highly chemotherapy sensitive, many remain resistant and require multimodalities of treatment. Immunotherapy has been developed to harness the immune system in fighting solid tumors, though not all have targeted effects. Some solid tumors are treated with autologous transplants; however, they do not always demonstrate an improved event free survival or overall survival. There has been evidence of the use of allogeneic stem cell transplants to provide a graft versus tumor effect, though studies remain limited.

By utilizing αβ-T cell and B cell depletion for stem cell transplants and combining with zoledronic acid, the immune system may potentially be harnessed and enhanced to provide an improved graft versus tumor effect in relapsed/refractory solid tumors and promote an improved event-free survival and overall survival.

This study will investigate the safety of treatment with a stem cell graft depleted of αβ-T cell and CD19+ B cells in combination with zoledronic acid in pediatric and young adult patients with select solid tumors, as well as whether this treatment improves survival rates in these patients.

Eligibility criteria

Qualifiers

Patients 6 months to ≤ 25 years old

neuroblastoma (high risk with relapsed or refractory disease),

relapsed/refractory rhabdomyosarcoma,

relapsed/refractory non-rhabdomyosarcoma soft tissue sarcoma (NRSTS): synovial sarcoma, malignant peripheral nerve sheath tumors (MPNST),

Disqualifiers

Patients with documented uncontrolled infection at the time of study entry are not eligible.

Patients with progressive solid tumor disease after relapsed/refractory treatment.

Demonstrated lack of compliance with medical care, as determined by the treating physician.

Patients who have received an allogeneic HSCT within 6 months.

Trial design

Treatments tested in this trial

  • Miltenyi CliniMACS Prodigy ® system
  • Zoledronic acid

Treatment groups

27 Participants
are divided into 1 treatment group

Sponsors and collaborators

University of Florida

Lead sponsor

Ocala Royal Dames for Cancer Research

Collaborator

Florida Department of Health

Collaborator