Immunotherapy for Solid Tumor Malignancies in Pediatrics Using Interleukin-15 and -21 Armored Glypican-3-specific Chimeric Antigen Receptor T Cells

Prior treatment

• History of hypersensitivity reactions to murine protein-containing products OR presence of human anti-mouse antibody (HAMA) prior to enrollment for patients who have received prior therapy with murine antibodies.
  • History of organ transplantation
  • Known HIV positivity
  • Active bacterial, fungal, or viral infection (except Hepatitis B or Hepatitis C virus infections)
• History of hypersensitivity reactions to murine protein-containing products OR presence of human anti-mouse antibody (HAMA) prior to enrollment for patients who have received prior therapy with murine antibodies.
  • History of organ transplantation
  • Known HIV positivity
• Live vaccines within 30 days prior to enrollment
  • Active bacterial, fungal, or viral infection (except Hepatitis B or Hepatitis C virus infections)
• Systemic steroid treatment (≥ 0.5 mg prednisone equivalent/kg/day, dose adjustment or discontinuation of medication must occur at least 24hrs prior to CAR T cell infusion)
• Congestive heart failure (as defined by New York Heart Association Functional Classification III or IV), unstable angina, serious uncontrolled cardiac arrhythmia, a myocardial infarction within 6 months prior to study entry or a history of myocarditis.

Other illness

• Active autoimmune or inflammatory disorder
• Uncontrolled infection

Other

• Treatment eligibility
• Pregnancy or lactation

• Diagnosis of a solid tumor expressing GPC3
• Lansky or Karnofsky score of \>=60%
• Life expectancy of \>16 weeks
• Informed consent explained to, understood by and signed by patient/guardian.
  • For patients with hepatocellular carcinoma only:
• Barcelona Liver Cancer Stage A, B or C
• Child-Pugh Turcotte Score \<7
• Lansky or Karnofsky score of \>=60%
• Life expectancy of \>16 weeks
• Informed consent explained to, understood by and signed by patient/guardian.
• Adequate organ function
• Adequate laboratory values
• Refractory or relapsed disease after treatment with up- front therapy and at least one salvage treatment cycle
• Recovered from acute toxic effects of all prior chemotherapy and investigational agents before entering this study
• Sexually active patients must be willing to utilize one of the more effective birth control methods for 12 months after the T-cell infusion.
• Informed consent explained to, understood by and signed by patient/guardian.
  • For patients with hepatocellular carcinoma only:
• Barcelona Liver Cancer Stage A, B or C
• Child-Pugh Turcotte Score \<7

Criteria the registry did not label

• Procurement Eligibility