INTERCEPT-GPC3: Interleukin-15 and -21 Armored Glypican-3 Specific Chimeric Antigen Receptor Expressing Autologous T-cells in Adults With GPC3-positive Solid Tumors
Seattle Children's Hospital
Summary
This Phase 1, open-label, non-randomized study will enroll 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). An adult participant 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.
Description
Study Overview This study is testing a different treatment which uses the body's own immune system to recognize and kill the cancer cells, called chimeric antigen receptor (CAR) T cells. Some solid tumors express a specific type of molecule called glypican-3 or GPC3. Seattle Children's Therapeutics (SCTx) are able to insert a new gene (a piece of DNA that contains a set of instructions for the body) into T cells which are a type of immune system cell. This is how SCTx make CAR T cells: they will insert a gene that will program the CAR T cell to recognize GPC3 to make GPC3-CAR T cells. To make…
Eligibility
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- No
1. Procurement Eligibility Inclusion Criteria: * Diagnosis of a solid tumor expressing GPC3 * Karnofsky score of \>=60% * Life expectancy of \>16 weeks * Informed consent explained to, understood by and signed by participant or participant's legally authorized representative 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…
Interventions
- BiologicalSC-CAR.GPC3xIL15.21 CAR T cells
Autologous SC-CAR.GPC3xIL15.21 T cell products infusion
Location
- Fred Hutch Cancer CenterSeattle, Washington