Clinical Trial Finder

Inclusion Criteria:

1. Age ≥ 12 months and < 30 years at the time of consent. The first patient on each dose level will need to be age ≥ 6 years old. 2. Disease Status: 1. Patients must have histologic verification of neuroblastoma at diagnosis or at relapse. 2. Patients must have high-risk neuroblastoma according to Children's Oncology Group (COG) risk classification at time of study enrollment. 3. Patients must have persistent/refractory or relapsed disease for which standard curative measures are no longer effective, as defined in the protocol. 4. Patients must have evaluable or measurable disease per the revised International Neuroblastoma Response Criteria (INRC) 3. Adequate washout from prior treatment regimens. 4. Adequate organ function. 5. Adequate performance status defined as Lansky or Karnofsky performance score ≥50% 6. Subjects of reproductive potential must agree to use acceptable birth control methods. 7. 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-effector cell therapy, are not eligible unless they are >8 weeks from time of infusion, have fully recovered from any associated toxicities and have documented lack of persistence of the product. 5. Patients with a known additional malignancy other than non-melanomatous skin cancer or carcinoma in situ, unless not requiring active treatment and stable or disease-free for at least 3 years. 6. Uncontrolled CNS metastasis. 7. CNS disorder such as cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or autoimmune disease with CNS involvement which may impair the ability to evaluate 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, inhaled steroids and premedication for blood products are allowed) 11. Primary immunodeficiency or history of systemic autoimmune disease requiring systemic immunosuppression/disease modifying agents within the last 2 years. 12. Uncontrolled intercurrent illness. 13. Inability to comply with the study requirements

This study consists of two phases. The primary objectives of Phase 1 and Phase 2 are: Phase 1:

• - To identify the maximum tolerated dose (MTD) of autologous hALK.

CAR T cells, and the recommended phase 2 dose (RP2D) in participants with relapsed/refractory high-risk neuroblastoma.

• - To evaluate the feasibility of manufacturing autologous hALK.

CAR T cells. Phase 2: To estimate the complete response (CR) and partial response (PR) rates per revised International Neuroblastoma Response Criteria (INRC) of participants with relapsed or refractory high-risk neuroblastoma who are treated with hALK.CAR T cells.

Arms

Experimental: Phase 1 Dose Escalation

The dose escalation arm will determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of hALK.CAR T cells using a standard 3+3 dose escalation design.

Interventions

Biological: - Autologous hALK.CAR T cells

Autologous chimeric antigen receptor T cells targeting the human Anaplastic Lymphoma Kinase (ALK) receptor