Phase 1 Study of GPC3-Targeted CAR T Cell Therapy with Interleukin-15 and -21 for Pediatric and Young Adult Solid Tumors

What this Trial Is About

Researchers are evaluating an experimental immunotherapy for children and young adults with solid tumors outside the central nervous system that express a molecule called glypican-3 GPC3. This Phase 1 study aims to assess the safety, feasibility, and effectiveness of special immune cells called CAR T cells that have been genetically modified to target GPC3 and enhanced with genes IL-15 and IL-21 to help them grow and last longer in the body. The study also includes a safety switch gene to control the CAR T cells if needed. Participants will have blood drawn to create personalized CAR T cells programmed to attack their tumors. After confirming eligibility, participants will receive lymphodepleting chemotherapy for three days to prepare the body, followed by a single infusion of the CAR T cells at Seattle Childrens Hospital. The study uses a dose escalation approach to determine the safest and most effective dose, with close monitoring for side effects during the first month after treatment. During the study, participants will have frequent visits for assessments including tumor evaluations, safety checks, and laboratory tests. After the initial month of monitoring, participants will continue follow-up visits for up to 15 years with decreasing frequency over time. Researchers will measure the ability to manufacture the CAR T cells, safety by tracking adverse events, dose limits, and changes in tumor burden to understand how the treatment works and its effects over the long term.

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