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

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age12+
SponsorEmory University

About this trial

The goal of this clinical trial is to determine the maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) of allogeneic expanded γδ T cells when delivered with Dinutuximab, temozolomide, irinotecan, and zoledronate in children with refractory or recurrent neuroblastoma or refractory/ relapsed osteosarcoma as well as to define the toxicities of allogeneic expanded γδ T cells when delivered with Dinutuximab, temozolomide, irinotecan, and zoledronate

Eligibility criteria

Qualifiers

Patients must be ≥ 12 months of age at the time of enrollment in the study.

Diagnosis: Histological confirmation of neuroblastoma or ganglioneuroblastoma at initial diagnosis. (Bone marrow samples with positive catecholamines are acceptable as confirmation of neuroblastoma) OR histological confirmation of osteosarcoma at diagnosis

First or greater relapse of neuroblastoma following completion of aggressive multi- drug frontline therapy.

First episode of progressive neuroblastoma during aggressive multi-drug frontline therapy.

Disqualifiers

Prior T cell therapy

Pregnancy, breast feeding, or unwillingness to use effective contraception during the study will not be entered on this study.

Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.

Patients with known active Central Nervous System (CNS) disease (excluding skull disease with intracranial extension). Patients with a history of CNS disease are required to have a brain CT and/ or MRI at study registration.

Trial design

Treatments tested in this trial

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

Treatment groups

24 Participants
are divided into 1 treatment group

Sponsors and collaborators