Engineered Neuroblastoma Cellular Immunotherapy (ENCIT)-01

Prior treatment

• Presence of any concurrent medical condition that, in the opinion of the protocol PI or designee, would prevent the patient from undergoing protocol-based therapy.
• Receiving any other anti-cancer agents or radiotherapy at the time of study entry

Other illness

• History of relevant CNS pathology or current relevant CNS pathology (non-febrile seizure disorder requiring ongoing anti-epileptic medications, paresis, aphasia, cerebrovascular ischemia/hemorrhage, severe brain injuries, dementia, cerebellar disease, organic brain syndrome, psychosis, coordination or movement disorder). Patients may have CNS intracranial tumor.
• Presence of active malignancy other than NB
• Presence of known intracranial metastatic neuroblastoma. Skull based disease with soft tissue extension is allowed.
• Presence of active severe infection
• Presence of a primary immunodeficiency/bone marrow failure syndrome

Other

• Pregnant or breast-feeding
• Unable to tolerate apheresis procedure including placement of temporary apheresis catheter if necessary
• Unwilling or unable to provide consent/assent for participation in the study and 15-year follow-up

• Prior diagnosis of NB or ganglioneuroblastoma either by histologic verification and/or demonstration of tumor cells in the bone marrow with increased catecholamine levels.
• Male or female subjects ≤ 26 years of age
• Diagnosis of high risk NB at initial diagnosis or if non-high risk at time of initial diagnosis must have had evidence of metastatic progression when \> 18 months of age.
• Measurable or evaluable disease
• Lansky or Karnofsky performance status score of ≥ 50
• Life expectancy of ≥ 8 weeks.
• Recovered from significant acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to enrollment onto this study.
• ≥ 7 days since last chemotherapy or biologic therapy administration
• No systemic corticosteroids (unless physiologic replacement dosing) within 7 days of enrollment. Topical Administration (e.g. inhaled or dermatologic) is allowed.
• ≥ 3 half-lives or 30 days from time of last dose of anti-tumor directed antibody therapy, whichever is shorter from time of enrollment
• ≥ 6 weeks from myeloablative therapy and autologous stem cell transplant (timed from stem cell infusion). Patients who received stem cell infusion following non-myelo-ablative therapy are eligible once they meet all other eligibility requirements. Patient must NOT have received a prior allogeneic hematopoietic stem cell transplant.
• No prior genetically modified cell therapy that is still detectable.
• Must not be receiving external beam radiation therapy at the time of study enrollment. ≥ 12 weeks from prior I131 MIBG therapy.
• Adequate organ function
• Adequate laboratory values
• Negative HIV antigen and antibody, Hepatitis B surface antigen and Hepatitis C antibody within 3 months prior to enrollment. For patients with positive Hepatitis C Ab, negative PCR testing must be documented in order to be eligible.