Study of hALK.CAR T Cells for Patients with Relapsed/refractory High-risk Neuroblastoma

Inclusion Criteria:

1. Age ≥ 12 months and < 30 years at the time of consent. The first patient on eachdose level will need to be age ≥ 6 years old

2. Disease Status:

3. Patients must have histologic verification of neuroblastoma at diagnosis or atrelapse

4. Patients must have high-risk neuroblastoma according to Children's OncologyGroup (COG) risk classification at time of study enrollment

5. Patients must have persistent/refractory or relapsed disease for which standardcurative measures are no longer effective, as defined in the protocol

6. Patients must have evaluable or measurable disease per the revisedInternational Neuroblastoma Response Criteria (INRC)

7. Adequate washout from prior treatment regimens

8. Adequate organ function

9. Adequate performance status defined as Lansky or Karnofsky performance score ≥50%

10. Subjects of reproductive potential must agree to use acceptable birth controlmethods

11. Signed informed consent

Exclusion Criteria:

1. Pregnant or nursing (lactating) women

2. Patients with uncontrolled active infection

3. Patients who are concurrently receiving other investigational agents

4. Patients who have received prior CART-cell or other gene-modified immune-effectorcell therapy, are not eligible unless they are >8 weeks from time of infusion, havefully recovered from any associated toxicities and have documented lack ofpersistence of the product

5. Patients with a known additional malignancy other than non-melanomatous skin canceror carcinoma in situ, unless not requiring active treatment and stable ordisease-free for at least 3 years

6. Uncontrolled CNS metastasis

7. CNS disorder such as cerebrovascular ischemia/hemorrhage, dementia, cerebellardisease, or autoimmune disease with CNS involvement which may impair the ability toevaluate neurotoxicity

8. History of severe hypersensitivity reaction to compounds used in the study

9. HIV/HBV/HCV infection

10. Patients receiving systemic steroid therapy (physiologic replacement, inhaledsteroids and premedication for blood products are allowed)

11. Primary immunodeficiency or history of systemic autoimmune disease requiringsystemic immunosuppression/disease modifying agents within the last 2 years

12. Uncontrolled intercurrent illness

13. Inability to comply with the study requirements