Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: INTERVENTIONAL
Official Title: A Phase I Study of Allogeneic Ex Vivo Expanded Gamma Delta (??) T Cells (IND # 28460) in Combination With Dinutuximab, Temozolomide, Irinotecan, and Zoledronate in Children With Refractory, Relapsed,
Brief Summary:
High risk neuroblastoma is an aggressive and often lethal pediatric solid tumor.
Survival remains less than 50% and those patients who do survive suffer many treatment-related acute and chronic toxicities.
Chemoimmunotherapy using a combination of an anti-GD2 monoclonal antibody (dinutuximab) and different chemotherapy agents in the relapsed/refractory (r/r) neuroblastoma population, has demonstrated the most robust response rates to date, shifting the clinical practice to administer chemoimmunotherapy as a standard treatment for patients with r/r neuroblastoma.
The goal of this study is to improve upon GD2 chemoimmunotherapy regimens for neuroblastoma by delivering standard drugs like temozolomide, irinotecan, and dinutuximab in combination with a novel cell-based immunotherapy called gamma delta (??) T cells in addition to zoledronate that enhances ?? T cell activation and potency.
?? T cells are an innovative approach to cell therapy for neuroblastoma as they are major histocompatibility complex (MHC) independent and directly cytotoxic to tumor cells without the need for engineering them to recognize the tumor.
The study team has developed a Good Manufacturing Practice (GMP)-compliant manufacturing strategy to expand safe ?? T cells from healthy donors for this trial.
This is a Phase 1 study to determine the safety, recommended phase 2 dose, and preliminary efficacy of allogeneic (third party), ex vivo expanded ?? T cells in combination with dinutuximab, temozolomide, irinotecan and zoledronate in children with refractory, relapsed, or progressive neuroblastoma.