Immunotherapy for Solid Tumor Malignancies in Pediatrics Using Interleukin-15 and -21 Armored Glypican-3-specific Chimeric Antigen Receptor T Cells
Eligible age
1–26 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: Seattle Children's Hospital
You may qualify if…
- ✓ 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%
You may not qualify if…
- ✕ 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)
- ✕ 2. Treatment eligibility
- ✕ 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
Where it's recruiting
Seattle
Source: ClinicalTrials.gov · NCT07148050 · last updated 2026-02-17