RecruitingPhase 1NCT04837547

PEACH TRIAL- Precision Medicine and Adoptive Cellular Therapy

PEACH TRIAL- Precision mEdicine and Adoptive Cellular tHerapy for the Treatment of Recurrent Neuroblastoma and Newly Diagnosed Diffuse Intrinsic Pontine Glioma (DIPG)


Sponsor

University of Florida

Enrollment

24 participants

Start Date

Sep 20, 2021

Study Type

INTERVENTIONAL

Conditions

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)).


Eligibility

Min Age: 1 YearMax Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called Tumor-specific ex vivo expanded autologous lymphocyte transfer (TTRNA-xALT) for people with diffuse intrinsic pontine glioma and neuroblastoma. The study is currently recruiting participants at 3 locations. People eligible for this study include aged 1 Year to 30 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALTumor-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

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NCT04837547


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