Immunotherapy for Solid Tumor Malignancies in Pediatrics Using Interleukin-15 and -21 Armored Glypican-3-specific Chimeric Antigen Receptor T Cells
Trial Parameters
Brief Summary
This Phase 1, open-label, non-randomized study will enroll pediatric and young adult subjects with relapsed or refractory non-central nervous system (CNS) malignant solid tumors expressing glypican-3 (GPC3) to examine the safety, feasibility, and efficacy of administering T cell products derived from peripheral blood mononuclear cells (PBMC) that have been genetically modified to co-express a GPC3-specific chimeric antigen receptor (CAR), interleukin (IL)-15 and IL-21 as well as the inducible caspase 9 (iC9) suicide gene (SC-CAR.GPC3xIL15.21 T cells). A child or young adult meeting all eligibility criteria and meeting none of the exclusion criteria will have a blood sample collected, which will be used to bioengineer the CAR T cells targeting their tumor.
Eligibility Criteria
1. Procurement Eligibility Inclusion Criteria: * 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 Exclusion Criteria: * 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) 2. Treatment eligibility Inclusion Criteria: * 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 va