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PEACH TRIAL- Precision Medicine and Adoptive Cellular Therapy
Sponsor: University of Florida
Summary
A Phase I open-label, multicenter study, to evaluate the safety, feasibility, and maximum tolerated dose (MTD) of treating children with newly diagnosed DIPG or recurrent neuroblastoma with molecular targeted therapy in combination with adoptive cell therapy (Total tumor mRNA-pulsed autologous Dendritic Cells (DCs) (TTRNA-DCs), Tumor-specific ex vivo expanded autologous lymphocyte transfer (TTRNA-xALT) and Autologous G-CSF mobilized Hematopoietic Stem Cells (HSCs)).
Official title: PEACH TRIAL- Precision mEdicine and Adoptive Cellular tHerapy for the Treatment of Recurrent Neuroblastoma and Newly Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG)
Key Details
Gender
All
Age Range
1 Year - 30 Years
Study Type
INTERVENTIONAL
Enrollment
24
Start Date
2021-09-20
Completion Date
2032-09
Last Updated
2026-04-28
Healthy Volunteers
No
Interventions
Tumor-specific ex vivo expanded autologous lymphocyte transfer (TTRNA-xALT)
There will be two immunotherapy products manufactured and administered to subjects enrolled on this trial. The first product will be autologous dendritic cells (DCs) loaded with total tumor messenger ribonucleic acid (mRNA) (TTRNA) derived from malignant tumors. The second product will be autologous T lymphocytes stimulated ex vivo against TTRNA antigens for autologous transfer (TTRNA-xALT). DCs are professional antigen-presenting cells critical for the initiation of B and T-cell responses in vivo.
Locations (3)
University of Florida
Gainesville, Florida, United States
Levine Children's Hospital
Charlotte, North Carolina, United States
Penn State Milton S. Hershey Medical Center and Children's Hospital
Hershey, Pennsylvania, United States