Active — Not RecruitingPhase 1

PEACH TRIAL- Precision Medicine and Adoptive Cellular Therapy

United States24 participantsStarted 2021-09-20

Plain-language 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)).

Who can participate

Age range1 Year – 30 Years

SexALL

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Inclusion criteria

✓. 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
✓. DIPG must be ≥ 3 years of age at enrollment
✓. ANC (Absolute neutrophil count) ≥ 1000/µl (unsupported- \>24 hrs off G-CSF and 7 days off neulasta)
✓. Platelets ≥ 100,000/µl (can be transfused)
✓. Hemoglobin \> 8 g/dL (can be transfused)

What they're measuring

Number of Participants with Dose Limiting Toxicities as a Measure of Safety and Tolerability

Timeframe: 2 years

Trial details

NCT IDNCT04837547

SponsorUniversity of Florida

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09

View on ClinicalTrials.gov More Neuroblastoma trials