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This study is examining genetically engineered GD2-targeting T cells (GD2 CAR T cells) together with a VZV vaccine, Fludarabine, and Cyclophosphamide in patients with refractory or metastatic GD2-positive sarcoma and neuroblastoma. It includes patients with relapsed or refractory osteosarcoma or high-risk neuroblastoma not responsive to standard treatment. The study is in Phase 1 and is active but not currently recruiting.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: Procurement: * Diagnosis of relapsed or refractory osteosarcoma OR relapsed or refractory high risk neuroblastoma not responsive to standard treatment. * Either previously infected with varicella zoster virus(VZV; chicken pox) or previously vaccinated with VZV vaccine * Karnofsky/Lansky score of greater than or equal to 50 * Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent Treatment: * Diagnosis of relapsed or refractory osteosarcoma OR relapsed or refractory high risk neuroblastoma not responsive to standard treatment. * Recovered from the acute toxic effects of all prior chemotherapy * Karnofsky/Lansky score of greater than or equal to 50 * Bilirubin less than or equal to 3x upper limit of normal, AST less than or equal to 5x upper limit of normal, Serum creatinine less than or equal to 2x upper limit of normal, Hgb greater than or equal to 7.0 g/dl, ANC\>500/uL, platelets \> 50,000/uL * Pulse oximetry of greater than or equal to 90% on room air * Sexually active patients must be willing to utilize one of the more effective birth control methods for 6 months after the CTL infusion. Male partner should use a condom. * Available autologous transduced cytotoxic T lymphocytes with greater than or equal to 20% expression of GD2 CAR and killing of GD2-positive targets greater than or equal to 20% in cytotoxicity assay * Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent Exclusion Criteria: Procurement: • Known primary immune deficiency or HIV positivity Treatment: * Severe intercurrent infection * Known primary immune deficiency or HIV positivity * Pregnant or lactating * History of hypersensitivity reactions to murine protein-containing products * Known allergy to VZV vaccine