PEACH TRIAL- Precision Medicine and Adoptive Cellular Therapy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age1-30
SponsorUniversity of Florida
About this trial
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 criteria
Qualifiers
Patients that have relapsed following standard of care therapy or having progressed during standard of care therapy and non-responsive/progressive to accepted curative chemotherapy.
Neuroblastoma must be age >12 months at enrollment
Newly-diagnosed patients willing to undergo biopsy
Must be within 2 months of diagnosis and prior to starting radiation
Disqualifiers
Absence of tumor on biopsy specimen or a diagnosis other than NBL or glioma on biopsy
Known autoimmune or immunosuppressive disease or human immunodeficiency virus infection.
Subjects with significant renal, cardiac, pulmonary, hepatic or other organ dysfunction.
Prior allergic reaction to GM-CSF or Td.
Trial design
Treatments tested in this trial
- Tumor-specific ex vivo expanded autologous lymphocyte transfer (TTRNA-xALT)
Treatment groups
24 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Florida
Lead sponsor
Beat Childhood Cancer Research Consortium
Collaborator
Source ClinicalTrials.gov