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.

NCT Number	NCT07148050
Lead Sponsor	Seattle Children's Hospital
Conditions	Solid Tumor (Excluding CNS), Liver Cell Carcinoma, Malignant Rhabdoid Tumor, Yolk Sac Tumor, Liposarcoma, Rhabdomyosarcoma, Embryonal Sarcoma of Liver, Wilms Tumor +2 more
Enrollment	21 participants
Start Date	2025-12-22
Primary Completion	2029-04-22 (estimated)
Study Completion	2044-04-22 (estimated)
Updated on ClinicalTrials.gov	2026-02-17