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