Study of CAR T-Cells Targeting the GD2 With IL-15+iCaspase9 for Relapsed/Refractory Neuroblastoma or Relapsed/Refractory Osteosarcoma

Más betegség

• Has a known additional malignancy that is active and/or progressive requiring treatment.
• History of hypersensitivity reactions to murine protein-containing products.
• History of hypersensitivity to cyclophosphamide or fludarabine.

Egyéb

• Pregnant or breastfeeding (NOTE: breast milk cannot be stored for future use while the mother is being treated on study).

• Written HIPAA authorization signed by legal guardian.
• Adequate performance status as defined by Lansky or Karnofsky performance status of ≥ 60 (Lansky for <16 years of age).
• Life expectancy ≥12 weeks.
• Histological confirmation of neuroblastoma or ganglioneuroblastoma at initial diagnosis. Bone marrow samples are acceptable as confirmation of neuroblastoma, confirmation of osteosarcoma at diagnosis
• High-risk neuroblastoma with persistent/refractory or relapsed disease, defined as:
  • First or greater relapse of neuroblastoma following completion of aggressive multi-drug frontline therapy.
  • First episode of progressive neuroblastoma during aggressive multi-drug frontline therapy. Persistent/refractory neuroblastoma as defined by less than a complete response by the revised International Neuroblastoma Response Criteria (INRC) at the conclusion of at least 4 cycles of aggressive multidrug induction chemotherapy on or according to a high-risk neuroblastoma protocol (such as A3973 or ANBL0532).
  • Patients must be diagnosed with high risk neuroblastoma at initial diagnosis or if non-high risk at time of initial diagnosis must have had evidence of metastatic progression when >18 months of age as defined in the protocol or relapsed or refractory osteosarcoma that is not responsive to standard treatment.
• Measurable or evaluable disease per Revised INRC for subjects with neuroblastoma or measurable disease by Response Evaluation Criteria In Solid Tumors Criteria (RECIST) v1.1 criteria for subjects with osteosarcoma.
• Adequate central nervous system function as defined by:
  • No known Central Nervous System ( CNS) disease
  • No seizure disorder requiring antiepileptic drug therapy

A regiszterben nem jelölt feltételek

• All clinical and laboratory data required for determining eligibility must be available in the subject's medical/research record which will serve as the source document.
• Because of the nature of iC9.GD2.CAR.IL-15 T cell product preparation, subjects will be assessed for initial study enrollment eligibility (prior to cell procurement) and then will have to meet criteria prior to starting lymphodepletion and prior to T cell infusion.