Allogeneic Expanded Gamma Delta T Cells With GD2 Chemoimmunotherapy in Relapsed /Refractory Neuroblastoma or Refractory/ Relapsed Osteosarcoma

PHASE1RecruitingINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

November 6, 2023

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2025

Conditions
NeuroblastomaRefractory NeuroblastomaRelapsed NeuroblastomaRelapsed OsteosarcomaRefractory Osteosarcoma
Interventions
COMBINATION_PRODUCT

Ex Vivo Expanded Allogeneic γδ T Cells in Combination with Dinutuximab, Temozolomide, Irinotecan and Zoledronate

"The cell dose will be based on the subject's body weight. Subjects will receive a single infusion of third party, ex vivo expanded, frozen then thawed γδ T cell product at a dose of 3 x 106 cells/kg on Day 6 and then if they meet criteria for subsequent γδ T cell dose will receive a second dose of 3 x 106 cells/kg on Day 13. The dose will be escalated to 1 x 10\^7 and then 3 x 10\^7 cells/kg. In absence of any dose limiting toxicity, 3 x 10\^7 cells/kg will be accepted as the maximal dose.~Dinutuximab (17.5 mg/m2), temozolomide (100 mg/m2),irinotecan (50 mg/m2) and zoledronic acid (0.0125 mg/kg/dose) will be consistent across all dose levels."

Trial Locations (1)

30322

RECRUITING

Children's Healthcare of Atlanta, Atlanta

All Listed Sponsors
lead

Emory University

OTHER