Immunotherapy of Neuroblastoma Patients Using a Combination of Anti-GD2 and NK Cells

Inclusion Criteria:

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A) Inclusion criteria for activated NK cell Recipient:

1. Age 6 months to 25 years old.
2. Patients with high risk or relapsed neuroblastoma who have measurable residual disease (based on imaging findings with Curie scoring or MIBG or PET imaging criteria) after receiving or has refused to receive standard therapy.

   1. High risk will be defined as stage IV disease with poor response to chemotherapy. Residual disease after surgery or prior to autologous stem cell rescue which is part of Standard of Care. Infants with nMYC amplification will not automatically qualify for the protocol unless they have residual disease after surgery.
   2. Recurrence after completion of standard treatment.
3. Shortening fraction greater than or equal to 25% or Left ventricular ejection fraction (LVEF) greater than or equal to 40%.
4. Glomerular filtration rate greater than or equal to 60 ml/min/1.73 m2.
5. Pulse oximetry greater than or equal to 92% on room air.
6. Direct bilirubin less than or equal to 3.0 mg/dL (50 mmol/L).
7. Alanine aminotransferase (ALT) is no more than 2 times the upper limit of normal.
8. Aspartate transaminases (AST) is no more than 2 times the upper limit of normal.
9. Karnofsky or Lansky performance score of greater than or equal to 50.
10. Does not have a current pleural or pericardial effusion.
11. Has a suitable adult family member donor available for NK cell donation.
12. Has recovered from all acute NCI Common Terminology Criteria for Adverse Events (CTCAE) grade II-IV non-hematologic acute toxicities resulting from prior therapy per the judgment of the PI.
13. At least two weeks since receipt of any biological therapy, systemic chemotherapy, and/or radiation therapy.
14. Is not receiving more than the equivalent of prednisone 10 mg daily.
15. Not pregnant (negative serum or urine pregnancy test to be conducted within 7 days prior to enrollment).
16. Not lactating.

B) Inclusion criteria for NK cell Donor:

1. First and second degree relative acceptable.
2. 18 years of age or above.
3. Not lactating.
4. Greater than or equal to 3 of 6 HLA match to recipient.
5. .Meets eligibility and suitability criteria for hematopoietic cells donation as per institutional guidelines.
6. Not pregnant (negative serum or urine pregnancy test to be conducted within 7 days prior to enrollment).

Exclusion Criteria:

* Failure to meet any of the above criteria