PHOX2B PC-CAR T Cells for Relapsed Neuroblastoma

Eligibility Criteria

• * 1. Patients must be ≥ 1 years of age
• * 2. Patients must demonstrate expression of at least one of the following HLA alleles by HLA genotyping (conducted at CHOP) to be eligible.
• 3. Patients must have high-risk neuroblastoma according to COG risk classification at the time of study enrollment. Patients who were initially considered low- or intermediate-risk, but then reclassified as high-risk are also eligible.
• 4. Patients must have a previously histologically confirmed diagnosis of neuroblastoma That is recurrent/relapsed or refractory/persistent according to INRC AND For which standard curative measures do not exist or are no longer effective. Patients at first relapse are eligible as no known curative therapies exist for relapsed high-risk neuroblastoma.
• 5. Patients must have evaluable or measurable disease at enrollment. 5. The patient must have experienced at least one of the following:
• 6. Patients must have a Lansky (≤ 16 years) or Karnofsky (\> 16 years) score of ≥ 60.
• 7. Patients must have adequate renal function defined as age-adjusted serum creatinine ≤1.5 ULN for age: Age Male Female 12 months to \< 2 years 0.6 0.6 2 to \< 6 years 0.8 0.8 6 to \< 10 years 1.0 1.0 10 to \< 13 years 1.2 1.2 13 to \< 16 years 1.5 1.4
• * 16 years 1.7 1.4
• 8. Liver Function as follows:
• 1. Total bilirubin ≤ 1.5 x ULN (exception: total bilirubin ≤ 3 ULN for patients with Gilbert's Disease or liver metastases).
• 2. Alanine aminotransferase (ALT) ≤ 3.0 ULN (exception: ALT ≤ 5 x ULN for patients with liver metastases).
• 3. Aspartate aminotransferase (AST) ≤ 3.0 ULN (exception: ALT ≤ 5 x ULN for patients with liver metastases).
• 9. Pulmonary Function as follows:
• 8. Cardiac Function as follows:
• 10. Patients of child-bearing potential ( patients who have reached menarche and have not experienced treatment-related premature ovarian failure) must have a negative serum pregnancy test performed at the time of screening It is recommended that all patients of reproductive potential use at least one medically acceptable form of contraception for at least 1 year after their last infusion of PHOX2B PC-CAR T cells. Investigators shall counsel patients on the importance of pregnancy prevention and the implications of an unexpected pregnancy.
• * 1. Patients with active hepatitis B or active hepatitis C. 2. Patients with active HIV infection (patients undergoing anti-retroviral therapy with undetectable HIV viral load are eligible).
• 3. Patients with uncontrolled active infection 4. Patients with primary or acquired immunodeficiency disorder. 5. Concurrent use of systemic steroids or immunosuppression at the time of cell infusion or cell collection, or a condition, in the treating physician's opinion, that is likely to require steroid therapy or immunosuppression during collection or after infusion. Steroids for disease treatment at times other than cell collection or at the time of infusion are permitted. Use of physiologic replacement hydrocortisone or inhaled steroids is permitted as well.
• 6. Patients with actively progressing CNS metastases, including parenchymal or leptomeningeal involvement. (Note: CNS imaging at screening is only required if there is a clinical indication of suspected CNS metastasis) 7. Active medical disorder that, in the opinion of the investigator, would substantially increase the risk of uncontrollable CRS and/or neurotoxicity.
• 8. Patients who have received any live vaccines within 30 days prior to enrollment.
• 9. Pregnant or nursing (lactating) patients.