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

Eligibility 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
• 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