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

Inclusion Criteria:

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

• Diagnosis: Histological confirmation of neuroblastoma or ganglioneuroblastoma atinitial diagnosis. (Bone marrow samples with positive catecholamines are acceptableas confirmation of neuroblastoma) OR histological confirmation of osteosarcoma atdiagnosis

• Response to prior therapy:

• High-risk neuroblastoma with refractory, relapsed or progressive disease,defined as:

• First or greater relapse of neuroblastoma following completion of aggressivemulti- drug frontline therapy.

• First episode of progressive neuroblastoma during aggressive multi-drugfrontline therapy.

• Persistent/refractory neuroblastoma as defined by less than a complete responseby the revised International Neuroblastoma Response Criteria (INRC) after atleast 4 cycles of aggressive multidrug induction chemotherapy on or accordingto a high-risk neuroblastoma protocol (such as A3973 or ANBL0532).

• Note that this excludes patients initially considered low or intermediate-riskneuroblastoma that progressed to high-risk disease but the patient has notprogressed after the diagnosis of high-risk neuroblastoma.

• Relapsed or refractory osteosarcoma that is not responsive to standardtreatment

• Disease Status

• Patients must have measurable or evaluable disease per revised INRC forsubjects with neuroblastoma or measurable or evaluable disease by ResponseEvaluation Criteria in Solid Tumors (RECIST) v1.1 for subjects withOsteosarcoma

• Performance Level:Patients must have a Lansky (≤16 years) or Karnofsky (>16years) score of ≥50

• Prior Therapy

• Patients must have fully recovered from the acute toxic effects of all priorchemotherapy, immunotherapy, or radiotherapy before study registration.

• Prior dinutuximab therapy is allowed regardless of prior response orprogression on dinutuximab

• Prior temozolomide therapy is allowed

• Prior zoledronate is allowed

• Prior dinutuximab/temozolomide/irinotecan chemoimmunotherapy is allowed

• Prior T cell therapy is excluded

• Organ Function Requirements:

• Hematologic Functions : Absolute Neutrofil count ≥750/uL and platelet count ≥ 75,000/µl, transfusion independent .

• Renal Function: Patients must have adequate renal function defined asage-adjusted serum creatinine ≤1.5 ULN for age.

• Liver Function: Total bilirubin ≤ 1.5 x ULN for age and serum glutamic-pyruvictransaminase (SGPT) (ALT) ≤ 135 U/L (≤ 3x ULN).

• Cardiac Function: Normal ejection fraction (≥ 55%) documented by eitherechocardiogram or radionuclide multigated acquisition scan (MUGA) evaluation ORNormal fractional shortening (≥ 27%) documented by echocardiogram

• Pulmonary Function: Normal pulmonary function with no evidence of dyspnea atrest, no exercise intolerance.

Exclusion Criteria:

• Prior T cell therapy

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

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

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

• Patients with prior allogeneic stem cell transplant

• Patients who are on hemodialysis

• Patients with an active or uncontrolled infection. Patients on prolonged antifungaltherapy are still eligible if they are culture negative, afebrile, and meet otherorgan function criteria

• Known history of human immunodeficiency virus (HIV) infection, hepatitis B, orhepatitis C. Testing is not required in the absence of clinical findings orsuspicion.

• Patients with disease of any major organ system that would compromise their abilityto withstand therapy.

• Patients who have had to permanently discontinue Dinutuximab due to toxicity

• Patients with serious, uncontrolled cardiac arrhythmias

• Patients with a history of myocarditis

• Patients who have received any live vaccines within 30 days before enrollment