Phase I Study of Donor Gamma Delta T Cells with Chemoimmunotherapy for Children with Refractory or Relapsed Neuroblastoma and Osteosarcoma

What this Trial Is About

This research aims to find the highest safe dose and the recommended dose for Phase II of a treatment using allogeneic expanded gamma delta T cells alongside dinutuximab, temozolomide, irinotecan, and zoledronate in children with difficult-to-treat or returning neuroblastoma or osteosarcoma. These cancers are aggressive pediatric solid tumors with survival rates under 50%, highlighting the need for new targeted therapies. The study focuses on safety, toxicity, and early effectiveness of this novel cell therapy combined with chemotherapy and immunotherapy. Participants will receive a single infusion of donor-derived, expanded T cells on Day 6 after completing a regimen of dinutuximab, temozolomide, irinotecan, and zoledronate. If eligible, a second T cell infusion occurs on Day 13. The T cell dose starts at 3 million cells per kilogram and may increase up to 30 million cells per kilogram following a standard dose escalation design. Patients may receive up to four courses, each including two infusions one week apart. Chemotherapy and immunotherapy doses remain consistent across dose levels. During the study, participants undergo evaluations for side effects and disease response after initial and later treatment courses. Blood samples may also be collected and stored for future research. Safety monitoring includes watching for toxicities from enrollment through 30 days after treatment. The maximum tolerated dose and recommended Phase II dose will be determined within 21 days. Participants will be followed for treatment effects and side effects throughout the study period.

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