Actively Recruiting
Alpha/Beta T and B Cell Depletion With Zoledronic Acid for Solid Tumors
Led by University of Florida · Updated on 2026-03-11
27
Participants Needed
1
Research Sites
207 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Alpha/Beta T and B Cell Depletion With Zoledronic Acid for Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 6 months to 25 years old
- Relapsed or refractory solid tumor with failure or ineligibility for autologous transplant or less than 20% chance of cure with autologous transplant, including neuroblastoma, rhabdomyosarcoma, non-rhabdomyosarcoma soft tissue sarcomas (such as synovial sarcoma and malignant peripheral nerve sheath tumors), high-risk adult-type soft tissue sarcomas, other high-risk extracranial solid tumors, relapsed/refractory bone tumors, or other high-risk solid tumors with less than 10% expected survival with conventional treatment
- No more than one active malignancy at enrollment (exceptions for prior or concurrent malignancies that do not affect safety or efficacy)
- Haplo-identical related donor with at least one full haplotype match
- Karnofsky or Lansky performance score of 60% or higher
- Adequate organ function within 4 weeks before starting preparative treatment, including lung function (FEV1, FVC, DLCO ≥ 50% predicted or no dyspnea and no supplemental oxygen for young children), kidney function (creatinine clearance or GFR ≥ 60 mL/min/1.73 m2 or age/gender appropriate serum creatinine), and heart function (ejection fraction ≥ 40%)
- Written informed consent and agreement to comply with study procedures
- Individuals capable of childbearing must use contraception during the study and for one year after transplant
- Partners of participants must also use physician-approved contraception during the study and for one year post-transplant
You will not qualify if you...
- Uncontrolled infection at study entry (no antimicrobial treatment or worsening despite treatment)
- Lack of compliance with medical care as determined by physician
- Receipt of allogeneic hematopoietic stem cell transplant within 6 months
- No eligible allogeneic donor available
- Life expectancy less than 3 months
- Organ function not meeting inclusion criteria
- Unwillingness or inability to use acceptable contraception during study and for one year after transplant
- Known pregnancy or breastfeeding
- Any other disease or condition that contraindicates study treatment or interferes with safety or results, as judged by physician
- Prisoners or involuntarily incarcerated individuals or those detained for psychiatric or physical illness treatment
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Florida
Gainesville, Florida, United States, 32610
Actively Recruiting
Research Team
G
Giselle Moore-Higgs, PhD, APRN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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