Testing CAR T cells against GPC3 in children with relapsed solid tumors
Tests modified immune T cells targeting GPC3 in young people with relapsed solid tumors.
Plain-language title generated from the registry record
Registry title: Immunotherapy for Solid Tumor Malignancies in Pediatrics Using Interleukin-15 and -21 Armored Glypican-3-specific Chimeric Antigen Receptor T Cells
Key facts
- Where
- Seattle, United StatesSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 1 and 26 years old?
Source: NCT07148050, who can take part
Where in United States
- Seattle Children's HospitalSeattle, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Seattle Children's Hospital
- Trial code
- NCT07148050
- Record updated
- 17 February 2026
- Original description
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).Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: 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); 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; Live vaccines within 30 days prior to enrollment; Active bacterial, fungal, or viral infection (except Hepatitis B or Hepatitis C virus infections); Systemic steroid treatment (≥ 0.5 mg prednisone equivalent/kg/day, dose adjustment or discontinuation of medication must occur at least 24hrs prior to CAR T cell infusion); Congestive heart failure (as defined by New York Heart Association Functional Classification III or IV), unstable angina, serious uncontrolled cardiac arrhythmia, a myocardial infarction within 6 months prior to study entry or a history of myocarditis; Active autoimmune or inflammatory disorder; Uncontrolled infection; Treatment eligibility; Pregnancy or lactation.
Procurement Eligibility.