P.E.A.C.H. Protocol Precision mEdicine and Adoptive Cellular tHerapy for the treatment of recurrent neuroblastoma and newly diagnosed diffuse intrinsic pontine glioma (DIPG).
Objective
Primary: 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 in two separate Study Arms. Arm 1: Subjects with DIPG. Arm 2: Subjects with Neuroblastoma. Secondary: To evaluate the overall safety profile of study treatment To evaluable the feasibility of producing and administering the protocol directed therapy To determine the activity of treatments chosen based on: Progression free survival (PFS). Overall Survival (OS). Overall response rate (ORR).