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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
Tumor-specific ex vivo expanded autologous lymphocyte transfer (TTRNA-xALT)
Biological/VaccineThere 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.
Treatment groups
24 Participants
are divided into 2 treatment groupsGroup A: Arm 1: Subjects with Diffuse Intrinsic Pontine Glioma (DIPG).Experimental treatment 1 intervention
Group B: Arm 2: Relapsed/Refractory Neuroblastoma (NB)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants with Dose Limiting Toxicities as a Measure of Safety and Tolerability
To evaluate the dose-limiting toxicities (DLTs) and to establish the maximum tolerated dose (MTD) of treating children with molecular targeted therapy in combination with adoptive cellular therapy
Time frame
2 yearsSecondary outcomes
1
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
To evaluate the overall safety profile of study treatment
Time frame
2 years plus 30 days2
Number of Participants that are able to have vaccine produced and delivered
To evaluable the feasibility of producing and administering the protocol directed therapy
Time frame
2 years3
Number of participants with progression free survival (PFS) during study
To determine the activity of treatments chosen based on Progression free survival (PFS)
Time frame
7 years4
Number of participants with overall survival (OS) during study
To determine the activity of treatments chosen based on Overall Survival (OS)
Time frame
7 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Florida
Lead sponsor
Beat Childhood Cancer Research Consortium
Collaborator
Source ClinicalTrials.gov